Proquin XR Side Effects

Generic Name: ciprofloxacin

Note: This page contains side effects data for the generic drug ciprofloxacin. It is possible that some of the dosage forms included below may not apply to the brand name Proquin XR.

It is possible that some side effects of Proquin XR may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ciprofloxacin: oral powder for suspension, oral tablet

Other dosage forms:

As well as its needed effects, ciprofloxacin (the active ingredient contained in Proquin XR) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking ciprofloxacin, check with your doctor immediately:

More common
  • Diarrhea
Rare
  • Bloody or black, tarry stools
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • changes in skin color
  • changes in urination
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills or fever
  • clumsiness or unsteadiness
  • confusion
  • continuing ringing or buzzing or other unexplained noise in the ears
  • coughing or spitting up blood
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, irregular, pounding, or racing heartbeat or pulse
  • headache, severe and throbbing
  • hearing loss
  • hives or welts
  • joint stiffness
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • muscle pain or stiffness
  • nausea and vomiting
  • nightmares
  • numbness of the hands
  • pain in the joints
  • pain or discomfort in the arms, jaw, back, or neck
  • painful, red lumps under the skin, mostly on the legs
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the face, neck, arms, and occasionally, upper chest
  • seizures
  • severe abdominal or stomach pain, cramping, or burning
  • shakiness in the legs, arms, hands, or feet
  • skin rash
  • swelling of the face, feet, or lower legs
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • thick, white vaginal discharge with no odor or with a mild odor
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • white patches in the mouth and/or on the tongue
  • yellow eyes or skin
Incidence not known
  • Acid or sour stomach
  • blistering, peeling, or loosening of the skin
  • bluish-colored lips, fingernails, or palms
  • bone pain
  • diarrhea, watery and severe, which may also be bloody
  • difficulty with breathing, chewing, or talking
  • double vision
  • excessive muscle tone
  • feeling of discomfort
  • feeling, seeing, or hearing things that are not there
  • increased sensitivity to pain
  • increased sensitivity to touch
  • irregular or slow heart rate
  • mood changes
  • nosebleeds
  • rapid heart rate
  • red skin lesions, often with a purple center
  • sores, ulcers, or white spots on the lips or in the mouth
  • unusual bleeding or bruising
  • unusual excitement, nervousness, or restlessness
  • vaginal yeast infection

Some ciprofloxacin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

Less common
  • Runny nose
  • sneezing
  • stuffy nose

For Healthcare Professionals

Applies to ciprofloxacin: intravenous solution, oral powder for reconstitution, oral tablet, oral tablet extended release

General

In clinical trials with oral and parenteral ciprofloxacin (the active ingredient contained in Proquin XR) 49,038 patients received courses of the drug. Most side effects were described as mild to moderate, subsided soon after the drug was discontinued, and required no treatment. Oral and IV ciprofloxacin were discontinued due to side effects in 1% and 1.8% of patients, respectively. IV ciprofloxacin was most frequently (greater than 1%) associated with nausea, diarrhea, central nervous system disturbance, local IV site reactions, abnormal liver function tests, eosinophilia, headache, restlessness, and rash; the majority of which were of mild to moderate severity. The most frequently reported drug-related effects, from clinical trials of all formulations, all dosages, all drug-therapy durations, and for all indications of ciprofloxacin therapy were nausea, diarrhea, abnormal liver function tests, vomiting, and rash.

Among patients surveyed by the CDC, more than 1000 received only ciprofloxacin for inhalational anthrax postexposure prophylaxis. Gastrointestinal side effects (nausea, vomiting, diarrhea, or stomach pain); neurological side effects (problems sleeping, nightmares, headache, dizziness, lightheadedness), and musculoskeletal side effects (muscle or tendon pain and joint swelling or pain) occurred more often than in previous controlled trials. This higher incidence, without a control group, may be due to reporting bias, concurrent medical conditions, other concomitant medications, emotional stress or other confounding factors, and/or a longer duration of ciprofloxacin therapy. Due to such factors, it was difficult to determine if the reported side effects were drug-related.

Gastrointestinal

Common (1% to 10%): Nausea (up to 4%), diarrhea (up to 2%), vomiting (up to 2%)
Uncommon (0.1% to 1%): Abdominal pain/discomfort, Clostridium difficile-associated diarrhea, constipation, dyspepsia, epigastric pain, dysphagia, flatulence, gastrointestinal bleeding, ileus, intestinal perforation, elevated amylase, elevated lipase, mouth dryness, oral candidiasis, oral ulceration, painful oral mucosa, pancreatitis, pseudomembranous colitis
Rare (less than 0.1%): Elevated serum amylase
Frequency not reported: Heartburn, acid reflux, aggravated irritable bowel syndrome, lower abdominal pain
Postmarketing reports: Clostridium difficile-associated diarrhea, constipation, dyspepsia, dysphagia, flatulence, gastrointestinal bleeding, ileus, intestinal perforation, elevated amylase, elevated lipase, oral and gastrointestinal moniliasis, oral candidiasis, oral ulceration, pancreatitis, pseudomembranous colitis

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

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

Dermatologic

Common (1% to 10%): Rash (IV: greater than 1%)
Uncommon (0.1% to 1%): Rash, pruritus, urticaria, cutaneous candidiasis, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis (Lyell's syndrome), increased perspiration, burning, erythema, erythema nodosum, photosensitivity/phototoxicity reaction, dry skin, maculopapular rash, skin disorder, vesiculobullous rash, hyperpigmentation, sweating
Rare (less than 0.1%): Photoinduced acute exanthematous pustulosis (at least 1 case)
Frequency not reported: Bullous pemphigoid
Postmarketing reports: Cutaneous candidiasis, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis (Lyell's syndrome), increased perspiration, erythema nodosum, photosensitivity/phototoxicity reaction, hyperpigmentation, sweating, acute generalized exanthematous pustulosis (AGEP)

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.

Nervous system

One survey reported 11 cases of peripheral neuropathy associated with ciprofloxacin (the active ingredient contained in Proquin XR) The severity ranged from mild and reversible to severe and persistent. In one case, a 44-year-old female developed numbness, allodynia, hypoesthesia, 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.

Common (1% to 10%): Headache (up to 3%; IV: greater than 1%), dizziness (up to 2%), restlessness (IV: greater than 1%), central nervous system disturbance (IV: greater than 1%)
Uncommon (0.1% to 1%): Abnormal gait, ataxia, convulsive seizures (including status epilepticus), grand mal convulsion, irritability, lightheadedness, paresthesia, restlessness, syncope, tremor, weakness, unresponsiveness, tinnitus, hearing loss, bad taste, anosmia, migraine, incoordination, vertigo, taste perversion
Frequency not reported: Disturbance in attention, benign intracranial hypertension, dysesthesia, dyskinesia, neuropathy, paresis, aseptic meningitis
Postmarketing reports: Abnormal gait, ataxia, grand mal convulsion, lightheadedness, paresthesia, restlessness, unresponsiveness, agitation, hyperesthesia, hypoesthesia, tinnitus, hearing loss, taste loss, anosmia, migraine, peripheral neuropathy (may be irreversible), polyneuropathy, twitching, convulsion

Hypersensitivity

At least two cases have been reported of patients developing a cutaneous vasculitis related to ciprofloxacin (the active ingredient contained in Proquin XR) use. The vasculitis resolved without medical intervention following discontinuation of the drug.

Anaphylactic reactions may occur at an increased incidence among HIV-infected individuals.

Uncommon (0.1% to 1%): Allergic reactions, anaphylactic reactions (including life-threatening anaphylactic shock), vasculitis, angioedema, edema (lips, face, neck, conjunctivae, hands, or lower extremities), vesicles
Frequency not reported: Allergic interstitial nephritis, lobular panniculitis, anaphylactoid reactions, necrotizing vasculitis, cutaneous vasculitis
Postmarketing reports: Allergic reactions (ranging from urticaria to anaphylactic reactions, including life-threatening anaphylactic shock), fixed eruptions, vasculitis, angioedema, edema (lips, face, neck, conjunctivae, hands, or lower extremities), vesicles, serum sickness-like reaction

Hepatic

The most frequently reported changes in laboratory parameters with IV ciprofloxacin (the active ingredient contained in Proquin XR) included elevated ALT, AST, alkaline phosphatase, LDH, and serum bilirubin.

Common (1% to 10%): Elevated ALT (1.9%), elevated AST (1.7%), abnormal liver function tests (up to 1.3%)
Uncommon (0.1% to 1%): Elevated alkaline phosphatase (0.8%), elevated LDH (0.4%), elevated serum bilirubin (0.3%), cholestatic jaundice, hepatitis, hepatic necrosis, jaundice
Rare (less than 0.1%): Elevated serum gamma glutamyltransferase
Postmarketing reports: Cholestatic jaundice, hepatitis, hepatic necrosis, hepatic failure (including fatal cases), jaundice

Renal

The most frequently reported changes in laboratory parameters with IV ciprofloxacin (the active ingredient contained in Proquin XR) included elevated serum creatinine, BUN, and uric acid.

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.

Common (1% to 10%): Elevated serum creatinine (1.1%)
Uncommon (0.1% to 1%): Elevated BUN (0.9%), renal failure, interstitial nephritis, nephritis, renal calculi, abnormal kidney function
Rare (less than 0.1%): Elevated uric acid, decreased BUN, decreased uric acid
Frequency not reported: Myoglobin-associated acute kidney injury/failure
Postmarketing reports: Renal failure, interstitial nephritis, nephritis, renal calculi

Local

Local IV site reactions occurred more often if the infusion time was 30 minutes or less.

Injection site irritation and induration have been reported with IV infusion over less than 30 minutes or when a small vein in the back of the hand was used. The manufacturer recommends an infusion time of 1 hour.

Common (1% to 10%): Local IV site reactions (IV: greater than 1%)
Uncommon (0.1% to 1%): Injection site reaction
Frequency not reported: Injection site irritation and induration with IV infusion

Musculoskeletal

The most frequently reported changes in laboratory parameters with IV ciprofloxacin (the active ingredient contained in Proquin XR) included elevated serum creatine phosphokinase.

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.

Uncommon (0.1% to 1%): Jaw, arm, or back pain, neck and/or chest pain, arthralgia, back pain, joint stiffness, achiness, myasthenia gravis, muscle weakness, gout flare-up, hypertonia
Frequency not reported: Joint swelling, muscle spasms, night cramps, elevated serum creatine phosphokinase, knee inflammation, suspected cases of reversible arthropathy
Postmarketing reports: Arthralgia, joint stiffness, achiness, gout flare-up, hypertonia, myoclonus, myasthenia, exacerbation of myasthenia gravis, tendinitis, tendon rupture, myalgia

Cardiovascular

Uncommon (0.1% to 1%): Angina pectoris, arrhythmia, atrial flutter, cardiac murmur, cardiopulmonary arrest, cardiovascular collapse, cerebral thrombosis, hypertension, hypotension, myocardial infarction, palpitation, phlebitis/thrombophlebitis, tachycardia, vasodilation, ventricular ectopy, bradycardia
Frequency not reported: Ventricular bigeminy, abdominal aortic bruit
Postmarketing reports: Angina pectoris, arrhythmia, atrial flutter, cardiac murmur, cardiopulmonary arrest, cardiovascular collapse, cerebral thrombosis, hypertension, hypotension, myocardial infarction, palpitation, phlebitis, tachycardia, ventricular ectopy, QT prolongation, torsade de pointes, ventricular arrhythmia, postural hypotension

Hematologic

Common (1% to 10%): Eosinophilia (IV: greater than 1%)
Uncommon (0.1% to 1%): Lymphadenopathy, petechiae, eosinophilia (0.6%), leukopenia (0.4%), decreased blood platelets (0.1%), increased blood platelets (0.1%), pancytopenia (up to 0.1%), agranulocytosis, prolongation of prothrombin time, purpura, decreased prothrombin time
Rare (less than 0.1%): Anemia, bleeding diathesis, decreased hemoglobin, decreased leukocytes, increased atypical lymphocyte count, immature white blood cells, increased blood monocytes, leukocytosis, hemolytic anemia, elevated sedimentation rate
Frequency not reported: Decreased hematocrit, thrombocytopenia, neutropenia
Postmarketing reports: Lymphadenopathy, petechiae, pancytopenia, agranulocytosis, anemia, bleeding diathesis, marrow depression (including life-threatening), prolongation of prothrombin time, hemolytic anemia, purpura, decreased prothrombin time, life-threatening or fatal pancytopenia, methemoglobinemia, increased international normalized ratio (INR) (in patients treated with vitamin K antagonists)

The most frequently reported changes in laboratory parameters with IV ciprofloxacin included elevated eosinophil and platelet counts, decreased platelet counts, hemoglobin and/or hematocrit.

Metabolic

Uncommon (0.1% to 1%): Anorexia, hyperglycemia, hypoglycemia, acidosis
Rare (less than 0.1%): Elevated serum calcium, elevated serum cholesterol, elevated serum potassium, decreased serum albumin, decreased serum potassium, decreased total serum protein, decreased blood glucose
Frequency not reported: Symptomatic hypoglycemia
Postmarketing reports: Acidosis, elevated serum triglycerides, elevated serum cholesterol, elevated blood glucose, elevated serum potassium

The most frequently reported changes in laboratory parameters with IV ciprofloxacin included elevated blood glucose and triglycerides.

Quinolone class antibiotics have been associated with symptomatic hypoglycemia.

Psychiatric

Uncommon (0.1% to 1%): Anxiety, confusion, drowsiness, depersonalization, depression (potentially culminating in self-injurious behavior, such as suicidal ideations/thoughts and attempted or completed suicide), dysphasia, hallucinations, insomnia, lethargy, manic reaction, nightmares, paranoia, phobia, toxic psychosis, abnormal dreams, somnolence
Frequency not reported: Catatonia
Postmarketing reports: Anxiety, confusion, delirium, drowsiness, hallucinations, lethargy, manic reaction, nightmares, paranoia, phobia, toxic psychosis

Respiratory

Uncommon (0.1% to 1%): Bronchospasm, dyspnea, epistaxis, hemoptysis, hiccough, laryngeal or pulmonary edema, pleural effusion, pulmonary embolism, respiratory arrest, respiratory distress
Frequency not reported: Wheeze, cough, upper respiratory tract infection, pharyngitis, nasopharyngitis
Postmarketing reports: Bronchospasm, dyspnea, epistaxis, hemoptysis, hiccough, laryngeal or pulmonary edema, pleural effusion, pulmonary embolism, respiratory arrest, respiratory distress

Ocular

Uncommon (0.1% to 1%): Decreased visual acuity, blurred vision, visual disturbances (flashing lights, overbrightness of lights, change in color perception), chromatopsia, diplopia, nystagmus, eye pain
Frequency not reported: Cataracts, multiple punctate lenticular opacities
Postmarketing reports: Decreased visual acuity, blurred vision, visual disturbances (flashing lights, overbrightness of lights, change in color perception), chromatopsia, nystagmus

Quinolone class antibiotics have been associated with cataracts and multiple punctate lenticular opacities.

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.

Common (1% to 10%): Vaginal moniliasis (up to 2%)
Uncommon (0.1% to 1%): Albuminuria, breast pain, candiduria, cylindruria, crystalluria, frequent urination, gynecomastia, hematuria, hemorrhagic cystitis, polyuria, urethral bleeding, urinary retention, vaginitis, dysmenorrhea
Frequency not reported: Urinary tract infection, fungal vaginosis, bacterial vaginitis, dysuria, abnormal urine odor, female genital pruritus, vaginal infection, urinary frequency, micturition urgency
Postmarketing reports: Albuminuria, candiduria, frequent urination, gynecomastia, hemorrhagic cystitis, polyuria, urethral bleeding, urinary retention, vaginal candidiasis, vaginal pruritus, vaginal moniliasis

Other

Uncommon (0.1% to 1%): Pain, foot pain, extremity pain, fever, chills, flushing, swelling, malaise, asthenia, thirst
Rare (less than 0.1%): Serum phenytoin alteration, Jarisch-Herxheimer reaction (at least 1 case)
Frequency not reported: Fatigue, suprapubic pain, rigors, tenderness, fungal infection, increased body temperature, elevated serum theophylline
Postmarketing reports: Fever, chills, flushing, serum phenytoin alteration, pain (arm, back, breast, chest, epigastric, eye, extremities, foot, jaw, neck, oral mucosa)

The most frequently reported changes in laboratory parameters with IV ciprofloxacin included elevated serum theophylline (in patients receiving theophylline concomitantly).

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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