Cipro Side Effects

Generic Name: ciprofloxacin,ciprofloxacin hydrochloride

Please note - some side effects for Cipro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Cipro - for the Consumer

Ciprofloxacin/Dexamethasone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ciprofloxacin/Dexamethasone:

Discomfort, pain, or itching in the ear.

Seek medical attention right away if any of these SEVERE side effects occur when using Ciprofloxacin/Dexamethasone:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ciprodex

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ciprodex:

Discomfort, pain, or itching in the ear.

Seek medical attention right away if any of these SEVERE side effects occur when using Ciprodex:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Cipro I.V.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cipro I.V.:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Cipro I.V.:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine or unusual change in the amount of urine; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; loss of consciousness; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath or trouble breathing; stomach cramps or pain; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ciprofloxacin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ciprofloxacin:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Ciprofloxacin:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine or unusual change in the amount of urine; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; loss of consciousness; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath or trouble breathing; stomach cramps or pain; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ciprofloxacin/Hydrocortisone

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Ciprofloxacin/Hydrocortisone. Seek medical attention right away if any of these SEVERE side effects occur when using Ciprofloxacin/Hydrocortisone:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); ear redness or swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Cipro HC Otic

All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with Cipro HC Otic. Seek medical attention right away if any of these SEVERE side effects occur when using Cipro HC Otic:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); ear redness or swelling.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Cipro

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cipro:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Cipro:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine or unusual change in the amount of urine; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; loss of consciousness; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath or trouble breathing; stomach cramps or pain; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ciprofloxacin Drops

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ciprofloxacin Drops:

Bad taste in the mouth; bloodshot eyes; crusting of eyelids; eye burning or discomfort; feeling of something in the eye; itching; sensitivity to light.

Seek medical attention right away if any of these SEVERE side effects occur when using Ciprofloxacin Drops:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eyelid swelling; irritation; vision changes; white crystals in the eye.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ciprofloxacin Ear Drops

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ciprofloxacin Ear Drops:

Discomfort, pain, or itching in the ear; headache.

Seek medical attention right away if any of these SEVERE side effects occur when using Ciprofloxacin Ear Drops:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased hearing; severe or persistent ear pain, itching, or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ciprofloxacin Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ciprofloxacin Extended-Release Tablets:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Ciprofloxacin Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine or unusual change in the amount of urine; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; loss of consciousness; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath or trouble breathing; stomach cramps or pain; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Cipro XR Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cipro XR Extended-Release Tablets:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Cipro XR Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine or unusual change in the amount of urine; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; loss of consciousness; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath or trouble breathing; stomach cramps or pain; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ciprofloxacin Ointment

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ciprofloxacin Ointment:

Bloodshot eyes; blurred vision; burning or discomfort; crusting of eyelids; dry eyes; feeling of something in the eye; sensitivity to light.

Seek medical attention right away if any of these SEVERE side effects occur when using Ciprofloxacin Ointment:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); eyelid swelling; irritation; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ciprofloxacin Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ciprofloxacin Suspension:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Ciprofloxacin Suspension:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine or unusual change in the amount of urine; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; loss of consciousness; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath or trouble breathing; stomach cramps or pain; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Cipro Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Cipro Suspension:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Cipro Suspension:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine or unusual change in the amount of urine; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; loss of consciousness; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath or trouble breathing; stomach cramps or pain; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Ciprofloxacin Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ciprofloxacin Tablets:

Diarrhea; dizziness; headache; loss of appetite; nausea; stomach upset; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Ciprofloxacin Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or tarry stools; burning, numbness, tingling, pain, or weakness of the arms, hands, legs, or feet; chest pain; dark urine or unusual change in the amount of urine; fainting; fever, chills, or unusual cough; hallucinations; inability to move or bear weight on a joint or tendon area; irregular heartbeat; loss of consciousness; moderate to severe sunburn; mood or mental changes (eg, new or worsening anxiety, agitation, confusion, depression, restlessness, sleeplessness); muscle pain or weakness; pain, soreness, redness, swelling, weakness, or bruising of a tendon or joint area; pale stools; persistent sore throat; red, swollen, blistered, or peeling skin; seizures; severe or persistent diarrhea; severe or persistent dizziness; shortness of breath or trouble breathing; stomach cramps or pain; suicidal thoughts or actions; tremors; unusual bruising or bleeding; unusual fatigue; vaginal yeast infection; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Cipro Side Effects - for the Professional

Cipro

Adverse Reactions in Adult Patients

During clinical investigations with oral and parenteral Ciprofloxacin, 49,038 patients received courses of the drug. Most of the adverse events reported were described as only mild or moderate in severity, abated soon after the drug was discontinued, and required no treatment. Ciprofloxacin was discontinued because of an adverse event in 1% of orally treated patients.

The most frequently reported drug related events, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of Ciprofloxacin therapy were nausea (2.5%), diarrhea (1.6%), liver function tests abnormal (1.3%), vomiting (1%), and rash (1%).

Additional medically important events that occurred in less than 1% of Ciprofloxacin patients are listed below.

BODY AS A WHOLE: headache, abdominal pain/discomfort, foot pain, pain, pain in extremities, injection site reaction (Ciprofloxacin intravenous)

CARDIOVASCULAR: palpitation, atrial flutter, ventricular ectopy, syncope, hypertension, angina pectoris, myocardial infarction, cardiopulmonary arrest, cerebral thrombosis, phlebitis, tachycardia, migraine, hypotension

CENTRAL NERVOUS SYSTEM: restlessness, dizziness, lightheadedness, insomnia, nightmares, hallucinations, manic reaction, irritability, tremor, ataxia, convulsive seizures, lethargy, drowsiness, weakness, malaise, anorexia, phobia, depersonalization, depression, paresthesia, abnormal gait, grand mal convulsion

GASTROINTESTINAL: painful oral mucosa, oral candidiasis, dysphagia, intestinal perforation, gastrointestinal bleeding, cholestatic jaundice, hepatitis

HEMIC/LYMPHATIC: lymphadenopathy, petechia

METABOLIC/NUTRITIONAL: amylase increase, lipase increase

MUSCULOSKELETAL: arthralgia or back pain, joint stiffness, achiness, neck or chest pain, flare up of gout, muscle weakness

RENAL/UROGENITAL: interstitial nephritis, nephritis, renal failure, polyuria, urinary retention, urethral bleeding, vaginitis, acidosis, breast pain

RESPIRATORY: dyspnea, epistaxis, laryngeal or pulmonary edema, hiccough, hemoptysis, bronchospasm, pulmonary embolism

SKIN/HYPERSENSITIVITY: allergic reaction, pruritus, urticaria, photosensitivity/phototoxicity reaction, flushing, fever, chills, angioedema, edema of the face, neck, lips, conjunctivae or hands, cutaneous candidiasis, hyperpigmentation, erythema nodosum, sweating

SPECIAL SENSES: blurred vision, disturbed vision (change in color perception, overbrightness of lights), decreased visual acuity, diplopia, eye pain, tinnitus, hearing loss, bad taste, chromatopsia

In several instances nausea, vomiting, tremor, irritability, or palpitation were judged by investigators to be related to elevated serum levels of theophylline possibly as a result of drug interaction with Ciprofloxacin.

In randomized, double-blind controlled clinical trials comparing Ciprofloxacin tablets (500 mg BID) to cefuroxime axetil (250 mg - 500 mg BID) and to clarithromycin (500 mg BID) in patients with respiratory tract infections, Ciprofloxacin demonstrated a CNS adverse event profile comparable to the control drugs.

Adverse Reactions in Pediatric Patients

Ciprofloxacin, administered IV and /or orally, was compared to a cephalosporin for treatment of complicated urinary tract infections (cUTI) or pyelonephritis in pediatric patients 1 to 17 years of age (mean age of 6 ± 4 years). The trial was conducted in the US, Canada, Argentina, Peru, Costa Rica, Mexico, South Africa, and Germany. The duration of therapy was 10 to 21 days (mean duration of treatment was 11 days with a range of 1 to 88 days). The primary objective of the study was to assess musculoskeletal and neurological safety within 6 weeks of therapy and through one year of follow-up in the 335 Ciprofloxacin- and 349 comparator-treated patients enrolled.

An Independent Pediatric Safety Committee (IPSC) reviewed all cases of musculoskeletal adverse events as well as all patients with an abnormal gait or abnormal joint exam (baseline or treatment-emergent). These events were evaluated in a comprehensive fashion and included such conditions as arthralgia, abnormal gait, abnormal joint exam, joint sprains, leg pain, back pain, arthrosis, bone pain, pain, myalgia, arm pain, and decreased range of motion in a joint. The affected joints included: knee, elbow, ankle, hip, wrist, and shoulder. Within 6 weeks of treatment initiation, the rates of these events were 9.3% (31/335) in the Ciprofloxacin-treated group versus 6 % (21/349) in comparator-treated patients. The majority of these events were mild or moderate in intensity. All musculoskeletal events occurring by 6 weeks resolved (clinical resolution of signs and symptoms), usually within 30 days of end of treatment. Radiological evaluations were not routinely used to confirm resolution of the events. The events occurred more frequently in Ciprofloxacin-treated patients than control patients, regardless of whether they received IV or oral therapy. Ciprofloxacin-treated patients were more likely to report more than one event and on more than one occasion compared to control patients. These events occurred in all age groups and the rates were consistently higher in the Ciprofloxacin group compared to the control group. At the end of 1 year, the rate of these events reported at any time during that period was 13.7% (46/335) in the Ciprofloxacin-treated group versus 9.5% (33/349) comparator-treated patients.

An adolescent female discontinued Ciprofloxacin for wrist pain that developed during treatment. An MRI performed 4 weeks later showed a tear in the right ulnar fibrocartilage. A diagnosis of overuse syndrome secondary to sports activity was made, but a contribution from Ciprofloxacin cannot be excluded. The patient recovered by 4 months without surgical intervention.

Findings Involving Joint or Peri-articular Tissues as Assessed by the IPSC

	Ciprofloxacin	Comparator
*The study was designed to demonstrate that the arthropathy rate for the Ciprofloxacin group did not exceed that of the control group by more than + 6%. At both the 6 week and 1 year evaluations, the 95% confidence interval indicated that it could not be concluded that Ciprofloxacin group had findings comparable to the control group.
All Patients (within 6 weeks)	31/335 (9.3%)	21/349 (6%)
95% Confidence Interval*	(-0.8%, +7.2%)
Age Group
≥ 12 months < 24 months	1/36 (2.8%)	0/41
≥ 2 years < 6 years	5/124 (4%)	3/118 (2.5%)
≥ 6 years < 12 years	18/143 (12.6%)	12/153 (7.8%)
≥ 12 years to 17 years	7/32 (21.9%)	6/37 (16.2 %)
All Patients (within 1 year)	46/335 (13.7%)	33/349 (9.5%)
95% Confidence Interval*	(-0.6%, + 9.1%)

The incidence rates of neurological events within 6 weeks of treatment initiation were 3% (9/335) in the Ciprofloxacin group versus 2% (7/349) in the comparator group and included dizziness, nervousness, insomnia, and somnolence.

In this trial, the overall incidence rates of adverse events regardless of relationship to study drug and within 6 weeks of treatment initiation were 41% (138/335) in the Ciprofloxacin group versus 31% (109/349) in the comparator group. The most frequent events were gastrointestinal: 15% (50/335) of Ciprofloxacin patients compared to 9% (31/349) of comparator patients. Serious adverse events were seen in 7.5% (25/335) of Ciprofloxacin-treated patients compared to 5.7% (20/349) of control patients. Discontinuation of drug due to an adverse event was observed in 3% (10/335) of Ciprofloxacin-treated patients versus 1.4% (5/349) of comparator patients. Other adverse events that occurred in at least 1% of Ciprofloxacin patients were diarrhea 4.8%, vomiting 4.8%, abdominal pain 3.3%, accidental injury 3%, rhinitis 3%, dyspepsia 2.7%, nausea 2.7%, fever 2.1%, asthma 1.8% and rash 1.8%.

In addition to the events reported in pediatric patients in clinical trials, it should be expected that events reported in adults during clinical trials or postmarketing experience may also occur in pediatric patients.

Postmarketing Adverse Event Reports

The following adverse events have been reported from worldwide marketing experience with fluoroquinolones, including Ciprofloxacin. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these events in labeling are typically based on one or more of the following factors: (1) seriousness of the event, (2) frequency of the reporting, or (3) strength of causal connection to the drug.

Agitation, agranulocytosis, albuminuria, anaphylactic reactions (including life-threatening anaphylactic shock), anosmia, candiduria, cholesterol elevation (serum), confusion, constipation, delirium, dyspepsia, dysphagia, erythema multiforme, exfoliative dermatitis, fixed eruption, flatulence, glucose elevation (blood), hemolytic anemia, hepatic failure (including fatal cases), hepatic necrosis, hyperesthesia, hypertonia, hypesthesia, hypotension (postural), jaundice, marrow depression (life threatening), methemoglobinemia, moniliasis (oral, gastrointestinal, vaginal), myalgia, myasthenia, exacerbation of myasthenia gravis, myoclonus, nystagmus, pancreatitis, pancytopenia (life threatening or fatal outcome), peripheral neuropathy, phenytoin alteration (serum), photosensitivity/phototoxicity reaction, polyneuropathy, potassium elevation (serum), prothrombin time prolongation or decrease, pseudomembranous colitis (The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.), psychosis (toxic), QT prolongation, renal calculi, serum sickness like reaction, Stevens-Johnson syndrome, taste loss, tendinitis, tendon rupture, torsade de pointes, toxic epidermal necrolysis (Lyell's Syndrome), triglyceride elevation (serum), twitching, vaginal candidiasis, vasculitis and ventricular arrhythmia.

Adverse events were also reported by persons who received Ciprofloxacin for anthrax post-exposure prophylaxis following the anthrax bioterror attacks of October 2001.

Adverse Laboratory Changes: Changes in laboratory parameters listed as adverse events without regard to drug relationship are listed below:

Hepatic	–	Elevations of ALT (SGPT) (1.9%), AST (SGOT) (1.7%), alkaline phosphatase (0.8%), LDH (0.4%), serum bilirubin (0.3%).
Hematologic	–	Eosinophilia (0.6%), leukopenia (0.4%), decreased blood platelets (0.1%), elevated blood platelets (0.1%), pancytopenia (0.1%).
Renal	–	Elevations of serum creatinine (1.1%), BUN (0.9%), CRYSTALLURIA, CYLINDRURIA, AND HEMATURIA HAVE BEEN REPORTED.

Other changes occurring in less than 0.1% of courses were: elevation of serum gammaglutamyl transferase, elevation of serum amylase, reduction in blood glucose, elevated uric acid, decrease in hemoglobin, anemia, bleeding diathesis, increase in blood monocytes, and leukocytosis.

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Side Effects by Body System - for Healthcare Professionals

General

In clinical trials, oral ciprofloxacin was most frequently associated with nausea (5.2%), diarrhea (2.3%), vomiting (2%), abdominal pain or discomfort (1.7%), headache (1.2%), restlessness (1.1%), and rash (1.1%). Most side effects were described as mild to moderate; 3.5% of patients discontinued treatment due to side effects. Intravenous ciprofloxacin was most frequently associated with nausea, diarrhea, central nervous system disturbance, infusion site reactions, hepatic enzyme abnormalities, eosinophilia, headache, restlessness, and rash. The majority of these effects were of mild to moderate severity.

Of the individuals (n=3428) taking oral ciprofloxacin for anthrax prophylaxis, side effects included severe nausea, vomiting, diarrhea, or abdominal pain (19%); fainting, lightheadedness, or dizziness (14%); heartburn or acid reflux (7%); rash, hives, or itchy skin (6%). Three percent discontinued it due to adverse events.

Gastrointestinal

The onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.

Nineteen percent of the individuals (n=3428) taking oral ciprofloxacin for anthrax prophylaxis reported severe nausea, vomiting, diarrhea, or abdominal pain, and 7% reported heartburn or acid reflux.

Extended-release ciprofloxacin (Proquin XR) reportedly has been associated with a lower incidence of gastrointestinal side effects.

Gastrointestinal side effects have included nausea, diarrhea, vomiting, heartburn, and acid reflux. Abdominal pain or discomfort, anorexia, Clostridium difficile-associated diarrhea, constipation, dyspepsia, dysphagia, flatulence, gastrointestinal bleeding, ileus, intestinal perforation, mouth dryness, oral and gastrointestinal moniliasis, mouth dryness, oral candidiasis, oral ulceration, painful oral mucosa, pancreatitis, aggravated irritable bowel syndrome, lower abdominal pain, and pseudomembranous colitis have been reported in up to 1% of patients.

Dermatologic

Dermatologic side effects have included rash (1%), and pruritus, urticaria, cutaneous candidiasis, flushing, increased perspiration, photosensitivity/phototoxicity reaction, and hyperpigmentation (less than 1%). Sweating has been reported. At least one case of photoinduced acute exanthematous pustulosis has been reported.

Six percent of the individuals (n=3428) taking ciprofloxacin for anthrax prophylaxis reported rashes, hives, or itchy skin.

Nervous system

Nervous system side effects have included abnormal gait, anorexia, ataxia, convulsive seizures, dizziness, drowsiness, dysphasia, grand mal convulsion, headache, insomnia, irritability, lethargy, lightheadedness, malaise, myasthenia gravis, paresthesia, restlessness, syncope, tremor, unresponsiveness, weakness, and disturbance in attention in less than 1% of patients. Agitation, benign intracranial hypertension, confusion, dysesthesia, dyskinesia, hyperesthesia, hypoesthesia, tinnitus, hearing loss, bad taste, taste loss, anosmia, migraine, neuropathy, paresis, peripheral neuropathy, polyneuropathy, exacerbation of myasthenia gravis, twitching, and aseptic meningitis have also been reported.

One survey reported 11 cases of peripheral neuropathy associated with ciprofloxacin. The severity ranged from mild and reversible to severe and persistent. In one case, a 44-year-old female developed numbness, allodynia, hypesthesia, tremors, electrical and diffuse burning sensations, twitching, disorientation, visual impairment, nausea, temperature intolerance, rash, and palpitations, and remained disabled after 29 months.

Seizures have been reported in 2 patients given ciprofloxacin and foscarnet. The temporal association between the onset of seizures and drug administration suggests a possible drug interaction, although a causal relationship could not be established in either case. Ciprofloxacin and foscarnet are individually epileptogenic, and their concurrent use may potentiate the risk of seizures.

Fourteen percent of the individuals (n=3428) taking ciprofloxacin for anthrax prophylaxis reported fainting, lightheadedness, or dizziness.

Hypersensitivity

At least two cases have been reported of patients developing a cutaneous vasculitis related to ciprofloxacin use. The vasculitis resolved without medical intervention following discontinuation of the drug.

Photosensitivity is seen most frequently when patients are exposed to intense sun, as for example when used for the treatment or prophylaxis of traveler's diarrhea.

A 27-year-old woman with mild systemic erythematosus developed toxic epidermal necrolysis (TEN) after starting a second course of oral ciprofloxacin following a previous 5-day course. She developed a rash, high fever, and diarrhea after taking the second dose and presented with diffuse rash, epidermal sloughing of 60% of the skin, desquamation of the lips, shock, and respiratory distress. She died on the twenty-eighth hospital day of TEN, right ventricular failure, and acute respiratory distress syndrome. As of 2003, 9 cases of TEN, including 5 fatalities, have been reported in the literature.

Hypersensitivity side effects have included anaphylaxis (including life-threatening anaphylactic shock), bullous pemphigoid, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, fixed eruption, toxic epidermal necrolysis (Lyell's syndrome), vasculitis, angioedema, edema of the lips, face, neck, conjunctivae, hands or lower extremities, purpura, fever, chills, flushing, pruritus, urticaria, vesicles, erythema nodosum, photosensitivity/phototoxicity reaction, allergic interstitial nephritis, lobular panniculitis, anaphylactoid reactions, necrotizing vasculitis, serum sickness-like reaction, and cutaneous vasculitis. Anaphylactic reactions may occur at an increased incidence among HIV-infected individuals.

Local

Local side effects have included injection site irritation and induration with intravenous infusion over less than 30 minutes or when a small vein in the back of the hand is used. The manufacturer recommends an infusion time of 1 hour. Thrombophlebitis, burning, pain, pruritus, paresthesia, erythema and swelling of the infusion site have been reported in less than 1% of patients.

Renal

Allergic interstitial nephritis resulting in nonoliguric renal failure has been described in a number of case reports. Several of the cases have included symptoms of rash, fever, and arthralgia and have been accompanied by eosinophilia and eosinophiluria. The cases of allergic interstitial nephritis have often responded to short courses of corticosteroid therapy.

Renal side effects have included increases in serum creatinine, BUN, and uric acid. Renal failure, interstitial nephritis, nephritis, and renal calculi have been reported in less than 1% of patients. Decreased BUN and decreased uric acid have also been reported.

Hepatic

Hepatic side effects have included cholestatic jaundice and hepatitis in less than 1% of patients. Hepatic necrosis, hepatic failure (including fatal cases), jaundice, and increased ALT, AST, alkaline phosphatase, LDH, serum bilirubin, and serum GGT have also been reported.

Musculoskeletal

Arthropathy is primarily a concern in pediatric patients. However, at least one case was described in an adult cystic fibrosis patient receiving ciprofloxacin. Although cystic fibrosis arthropathy (CFA) and hypertrophic pulmonary osteoarthropathy (HPOA) typically occur in 7% to 8% of the cystic fibrosis adult and adolescent population, the arthropathy exhibited in this patient did not resemble either. Several elements in its presentation strongly support the diagnosis of ciprofloxacin-induced arthropathy, such as: a consistent time of onset with other reported cases of suspected quinolone-induced arthropathy (usually 3 weeks after initiating therapy); a lack of history of arthralgia in the patient; reoccurrence upon rechallenge; and resolution of symptoms upon discontinuation of therapy (usually 2 weeks after termination of therapy).

Tendinitis with subsequent tendon rupture has been documented in a number of case reports. One patient with chronic renal failure developed bilateral Achilles tendon rupture after four days of ciprofloxacin therapy. Although renal transplant patients and those with end-stage renal disease tend to have an increased risk of Achilles tendinitis and rupture over the general population, quinolone use has been shown to further increase that risk (12% in quinolone-treated patients vs. 7% in nonquinolone-treated patients).

Twenty-five cases of Achilles tendon rupture have been reported to the FDA as of October 1994. Some ruptures have also occurred in the hand or shoulder. Other risk factors identified include age and corticosteroid use.

Musculoskeletal side effects have included jaw, neck, and back pain, neck and chest pain, arthralgia, joint stiffness, joint swelling, muscle spasms, night cramps, achiness, muscle weakness, and gout flare-up in less than 1% of patients. Knee inflammation, hypertonia, myoclonus, myasthenia, tendinitis, tendon rupture, myalgia, and suspected cases of reversible arthropathy have also been reported.

Cardiovascular

Cardiovascular side effects have included angina pectoris, arrhythmia, atrial flutter, cardiac murmur, cardiopulmonary arrest, cardiovascular collapse, cerebral thrombosis, hypertension, hypotension, migraine, myocardial infarction, palpitations, phlebitis, tachycardia, vasodilation, ventricular bigeminy, abdominal aortic bruit, and ventricular ectopy in less than 1% of patients. QT prolongation, torsades de pointes, ventricular arrhythmia, and postural hypotension have also been reported.

Hematologic

Hematologic side effects have included lymphadenopathy and petechiae in less than 1% of patients. Eosinophilia (0.6%), leukopenia (0.4%), decreased platelets (0.1%), increased platelets (0.1%), pancytopenia (0.1%), agranulocytosis, anemia, bleeding diathesis, bone marrow depression, decreased hemoglobin, decreased leukocytes, increased atypical lymphocyte count, immature white blood cells, increased monocytes, leukocytosis, prolongation of prothrombin time, hemolytic anemia, decreased hematocrit, thrombocytopenia, elevated sedimentation rate, decreased prothrombin time, neutropenia, life-threatening or fatal pancytopenia, and methemoglobinemia have also been reported.

Metabolic

Metabolic side effects have included acidosis; increases in serum calcium, serum amylase, lipase, triglycerides, cholesterol, blood glucose, serum creatine phosphokinase, and serum potassium; and decreases in serum albumin, serum potassium, total serum protein, and blood glucose. Quinolone class antibiotics have been associated with symptomatic hypoglycemia.

Respiratory

Respiratory side effects have included bronchospasm, dyspnea, epistaxis, hemoptysis, hiccough, laryngeal or pulmonary edema, pleural effusion, pulmonary embolism, respiratory arrest, and respiratory distress in less than 1% of patients. Wheeze, cough, upper respiratory tract infection, pharyngitis, and nasopharyngitis have also been reported.

Ocular

Ocular side effects have included decreased visual acuity, blurred vision, visual disturbances (flashing lights, overbrightness of lights, change in color perception), chromatopsia, diplopia, nystagmus, and eye pain. Quinolone class antibiotics have been associated with cataracts and multiple punctate lenticular opacities.

Psychiatric

Psychiatric side effects have included anxiety, catatonia, confusion, delirium, depersonalization, depression, hallucinations, manic reaction, nightmares, paranoia, phobia, and toxic psychosis in less than 1% of patients.

Genitourinary

Crystalluria has been reported in patients with alkaline urine and does not necessarily lead to nephrotoxicity. At physiological urinary pH, the risk of crystalluria is considered minor.

Genitourinary side effects have included albuminuria, breast pain, candiduria, cylindruria, crystalluria, frequent urination, gynecomastia, hematuria, hemorrhagic cystitis, polyuria, urethral bleeding, urinary retention, urinary tract infection, fungal vaginosis, bacterial vaginitis, dysuria, abnormal urine odor, female genital pruritus, and vaginitis in less than 1% of patients. Vaginal candidiasis, vaginal infection, urinary frequency, and micturition urgency have also been reported. Vaginal pruritus has been reported during postmarketing experience.

Other

Other side effects have included pain, foot or extremity pain, fatigue, suprapubic pain, rigors, tenderness, fungal infection, and increased body temperature. Oral ciprofloxacin has been associated with a case of Jarisch-Herxheimer reaction, characterized by hypotension, tachycardia, and disseminated intravascular coagulation, in a 14-year-old female with tickborne relapsing fever.

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