Proquin XR Side Effects

Generic Name: ciprofloxacin,ciprofloxacin hydrochloride

Please note - some side effects for Proquin XR 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 Proquin XR - for the Consumer

Proquin 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 Proquin 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 Proquin 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.

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Proquin XR Side Effects - for the Professional

Proquin XR

Two clinical trials enrolled 1,095 patients, of whom 547 patients received Proquin XR 500 mg once daily and 538 patients received CIPRO 250 mg twice daily for 3 days. The patients were followed for approximately 5 weeks after the end of study drug dosing. Most adverse events reported were described as mild to moderate in severity and required no treatment. Proquin XR was discontinued due to adverse reactions thought to be drug-related in 0.5% of patients.

The incidence of all adverse events (regardless of relationship to study drug) reported for at least 2% of patients treated with Proquin XR during the entire 5-week study period was as follows: fungal infection (2.6%), nasopharyngitis (2.6%), headache (2.4%), and micturition urgency (2.0%).

The incidence of adverse events (regardless of relationship to study drug) reported for at least 1% of patients treated with Proquin XR during study drug treatment and up to 3 days after study drug was headache (1.5%).

The incidence of adverse events, judged by investigators to be at least possibly drug-related, occurring any time during the study in at least 1% of Proquin XR-treated patients was fungal infection (1.6%).

Additional uncommon events, judged by the investigator to be at least possibly drug-related, occurring at any time during the study in less than 1% of Proquin XR-treated patients were:

Cardiac Disorders: ventricular bigeminy.

Immune System Disorders: hypersensitivity.

Gastrointestinal Disorders: abdominal pain, nausea, diarrhea, dyspepsia, aggravated irritable bowel syndrome, lower abdominal pain, vomiting.

General Disorders: suprapubic pain, fatigue, pain, rigors, tenderness.

Infections and Infestations: urinary tract infection, fungal vaginosis, bacterial vaginitis, vaginal candidiasis, vaginal infection, vaginitis.

Investigations: blood bilirubin increased, alanine aminotransferase increased, abdominal aortic bruit, aspartate aminotransferase increased, body temperature increased.

Musculoskeletal and Connective Tissue Disorders: joint swelling, muscle spasms, night cramps.

Nervous System Disorders: headache, dizziness, disturbance in attention, paresthesia.

Renal and Urinary Disorders: micturition urgency, dysuria, urinary frequency, abnormal urine odor.

Reproductive System and Breast Disorders: female genital pruritus.

Respiratory, Thoracic, and Mediastinal Disorders: dyspnea.

Skin/Subcutaneous Tissue Disorders: rash, photosensitivity/ phototoxicity reaction, pruritus, urticaria.

Reported Post-Marketing Adverse Events with Other Formulations of Ciprofloxacin

The following adverse events, some of them life threatening, regardless of incidence or relationship to drug, have been reported during clinical trials and from worldwide post-marketing experience in patients given ciprofloxacin (includes all formulations, all dosages, all drug-therapy, and all indications). Because these reactions have been reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or a causal relationship to drug exposure. The events in alphabetical order are:

Abnormal gait, achiness, acidosis, agitation, agranulocytosis, allergic reactions (ranging from urticaria to anaphylactic reactions), amylase increase, anemia, angina pectoris, angioedema, anosmia, anxiety, arrhythmia, arthralgia, ataxia, atrial flutter, bleeding diathesis, blurred vision, bronchospasm, C. difficile associated diarrhea, candidiasis (cutaneous, oral), candiduria, cardiac murmur, cardiopulmonary arrest, cardiovascular collapse, cerebral thrombosis, chills, cholestatic jaundice, chromatopsia, confusion, convulsion, delirium, depression, diplopia, drowsiness, dysphagia, dyspnea, edema (conjunctivae, face, hands, laryngeal, lips, lower extremities, neck, pulmonary), epistaxis, erythema multiforme, erythema nodosum, exfoliative dermatitis, fever, fixed eruptions, flushing, gastrointestinal bleeding, gout (flare up), grand mal convulsion, gynecomastia, hallucinations, hearing loss, hematuria, hemolytic anemia, hemoptysis, hemorrhagic cystitis, hepatic failure (including fatal cases), hepatic necrosis, hepatitis, hiccup, hyperesthesia, hyperpigmentation, hypertension, hypertonia, hypoesthesia, hypotension, ileus, insomnia, interstitial nephritis, intestinal perforation, jaundice, joint stiffness, lethargy, lightheadedness, lipase increase, lymphadenopathy, malaise, manic reaction, marrow depression, migraine, moniliasis (oral, gastrointestinal, vaginal), mouth dryness, myalgia, myasthenia, myasthenia gravis (possible exacerbation), myocardial infarction, myoclonus, nephritis, nightmares, nystagmus, oral ulceration, pain (arm, back, breast, chest, epigastric, eye, extremities, foot, jaw, neck, oral mucosa), palpitation, pancreatitis, pancytopenia, paranoia, paresthesia, peripheral neuropathy, perspiration (increased), petechia, phlebitis, phobia, photosensitivity/phototoxicity reaction pleural effusion, polyuria, postural hypotension, prothrombin time prolongation, pseudomembranous colitis (the onset of symptoms may occur during or after antimicrobial treatment), pulmonary embolism, purpura, renal calculi, renal failure, respiratory arrest, respiratory distress, restlessness, serum sickness-like reaction, Stevens-Johnson syndrome, sweating, syncope, tachycardia, taste loss, tendonitis, tendon rupture, tinnitus, torsade de pointes, toxic epidermal necrolysis, toxic psychosis, tremor, twitching, unresponsiveness, urethral bleeding, urinary retention, urination (frequent), vaginal pruritus, vasculitis, ventricular ectopy, vesicles, visual acuity (decreased), visual disturbances (flashing lights, change in color perception, overbrightness of lights), weakness.

Reported Laboratory Changes with Proquin XR and Other Formulations of Ciprofloxacin

The following laboratory adverse events were reported for Proquin XR-treated patients during clinical trials: anemia, blood bilirubin increased, alanine aminotransferase increased, aspartate aminotransferase increased, platelet count decreased, and hematuria. All events were reported for <1% of Proquin XR-treated patients, except for hematuria (1.2%).

The following adverse laboratory changes, in alphabetical order, regardless of incidence or relationship to drug, have been reported in patients given ciprofloxacin (includes all formulations, all dosages, all drug-therapy durations, and all indications):

Decreases in blood glucose, BUN, hematocrit, hemoglobin, leukocyte counts, platelet counts, prothrombin time, serum albumin, serum potassium, total serum protein, uric acid.

Increases in alkaline phosphatase, ALT (SGPT), AST (SGOT), atypical lymphocyte counts, blood glucose, blood monocytes, BUN, cholesterol, eosinophils counts, LDH, platelet counts, prothrombin time, sedimentation rate, serum amylase, serum bilirubin, serum calcium, serum cholesterol, serum creatinine phosphokinase, serum creatinine, serum gamma-glutamyl transpeptidase (GGT), serum potassium, serum theophylline (in patients receiving theophylline concomitantly), serum triglycerides, uric acid.

Others: albuminuria, change in serum phenytoin, crystalluria, cylindruria, immature WBCs, leukocytosis, methemaglobinemia, pancytopenia.

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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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