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In clinical trials, most of the adverse events were mild to moderate in severity and transient in nature. During clinical investigations with the recommended dosage, 1585 patients received sparfloxacin and 1331 patients received a comparator. The discontinuation rate due to adverse events was 6.6% for sparfloxacin versus 5.6% for cefaclor, 14.8% for erythromycin, 8.9% for ciprofloxacin, 7.4% for ofloxacin, and 8.3% for clarithromycin.
The most frequently reported events (remotely, possibly, or probably drug related with an incidence of ≥ 1%) among sparfloxacin treated patients in the US phase 3 clinical trials with the recommended dosage were: photosensitivity reaction (7.9%), diarrhea (4.6%), nausea (4.3%), headache (4.2%), dyspepsia (2.3%), dizziness (2.0%), insomnia (1.9%), abdominal pain (1.8%), pruritus (1.8%), taste perversion (1.4%), and QTc interval prolongation (1.3%), vomiting (1.3%), flatulence (1.1%), and vasodilatation (1.0%).
In US phase 3 clinical trials of shorter treatment duration than the recommended dosage, the most frequently reported events (incidence ≥ 1%, remotely, possibly, or probably drug related) were: headache (8.1%), nausea (7.6%), dizziness (3.8%), photosensitivity reaction (3.6%), pruritus (3.3%), diarrhea (3.2%), vaginal moniliasis (2.8%), abdominal pain (2.4%), asthenia (1.7%), dyspepsia (1.6%), somnolence (1.5%), dry mouth (1.4%), and rash (1.1%).
Additional possibly or probably related events that occurred in less than 1% of all patients enrolled in US phase 3 clinical trials are listed below:
BODY AS A WHOLE: fever, chest pain, generalized pain, allergic reaction, cellulitis, back pain, chills, face edema, malaise, accidental injury, anaphylactoid reaction, infection, mucous membrane disorder, neck pain, rheumatoid arthritis;
CARDIOVASCULAR: palpitation, electrocardiogram abnormal, hypertension, tachycardia, sinus bradycardia, PR interval shortened, angina pectoris, arrhythmia, atrial fibrillation, atrial flutter, complete AV block, first degree AV block, second degree AV block, cardiovascular disorder, hemorrhage, migraine, peripheral vascular disorder, supraventricular extrasystoles, ventricular extrasystoles, postural hypotension;
METABOLISM: gout, peripheral edema, thirst;
CENTRAL NERVOUS SYSTEM: paresthesia, hypesthesia, nervousness, somnolence, abnormal dreams, dry mouth, depression, tremor, anxiety, confusion, hallucinations, hyperesthesia, hyperkinesia, sleep disorder, hypokinesia, vertigo, abnormal gait, agitation, lightheadedness, emotional lability, euphoria, abnormal thinking, amnesia, twitching;
SKIN/HYPERSENSITIVITY: rash, maculopapular rash, dry skin, herpes simplex, sweating, urticaria, vesiculobullous rash, exfoliative dermatitis, acne, alopecia, angioedema, contact dermatitis, fungal dermatitis, furunculosis, pustular rash, skin discoloration, herpes zoster, petechial rash;
In the US phase 3 clinical trials, with the recommended dosage, the most frequently (incidence ≥ 1%) reported changes in laboratory parameters listed as adverse events, regardless of relationship to drug, were: elevated ALT (SGPT) (2.0%), AST (SGOT) (2.3%), and white blood cells (1.1%).
Increases for the following laboratory tests were reported in less than 1% of all patients enrolled in clinical trials: alkaline phosphatase, serum amylase, aPTT, blood urea nitrogen, calcium, creatinine, eosinophils, serum lipase, monocytes, neutrophils, total bilirubin, urine glucose, urine protein, urine red blood cells, and urine white blood cells.
Decreases for the following laboratory tests were reported in less than 1% of all patients enrolled in clinical trials: albumin, creatinine clearance, hematocrit, hemoglobin, lymphocytes, phosphorus, red blood cells, and sodium.
Postmarketing Adverse Events
The following are additional adverse events (regardless of relationship to drug) reported from worldwide postmarketing experience with sparfloxacin or other quinolones: acidosis, acute renal failure, agranulocytosis, albuminuria, anaphylactic shock, angioedema, anosmia, ataxia, bullous eruption, candiduria, cardiopulmonary arrest, cerebral thrombosis, convulsions, crystalluria, dysgeusia, dysphasia, ebrious feeling, embolism, erythema nodosum, exacerbation of myasthenia gravis, gastralgia, hemolytic anemia, hepatic failure, hepatic necrosis, hepatitis, hiccough, hyperpigmentation, interstitial nephritis, interstitial pneumonia, intestinal perforation, jaundice, laryngeal or pulmonary edema, manic reaction, numbness, nystagmus, painful oral mucosa, pancreatitis, pancytopenia, phobia, prolongation of prothrombin time, pseudomembranous colitis, Quincke's edema, renal calculi, rhabdomyolysis, sensory disturbance, Stevens-Johnson syndrome, squamous cell carcinoma, tendonitis, tendon rupture, tremor, thrombocytopenia, thrombocytopenia purpura, torsades de pointes, toxic epidermal necrolysis, toxic psychosis, urinary retention, uveitis, vaginal candidiasis, vasculitis.
elevation of serum triglycerides, serum cholesterol, blood glucose, serum potassium, decrease in WBC counts, RBC counts, hemoglobin level, hematocrit level, thrombocyte counts, elevation in GOT, GPT, ALP, LDH, γ-GTP, total bilirubin.
Read the Zagam (sparfloxacin) Side Effects Center for a complete guide to possible side effects
Sparfloxacin has no effect on the pharmacokinetics of digoxin.
Sparfloxacin does not increase plasma theophylline concentrations. Since there is no interaction with theophylline, interaction with other methylxanthines such as caffeine is unlikely.
Sparfloxacin does not increase the anti-coagulant effect of warfarin.
Cimetidine does not affect the pharmacokinetics of sparfloxacin.
Antacids and Sucralfate
Aluminum and magnesium cations in antacids and sucralfate form chelation complexes with sparfloxacin. The oral bioavailability of sparfloxacin is reduced when an aluminum-magnesium suspension is administered between 2 hours before and 2 hours after sparfloxacin administration. Similarly, the oral bioavailability of sparfloxacin may be reduced when Videx®, (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution is administered between 2 hours before and 2 hours after sparfloxacin administration. The oral bioavailability of sparfloxacin is not reduced when the aluminum-magnesium suspension is administered 4 hours following sparfloxacin administration.
Absorption of quinolones is reduced significantly by these preparations. These products may be taken 4 hours after sparfloxacin administration.
Probenecid does not alter the pharmacokinetics of sparfloxacin.
Drug/Laboratory Test Interactions
Sparfloxacin therapy may produce falsenegative culture results for Mycobacterium tuberculosisby suppression of mycobacterial growth.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/7/2009
Additional Zagam Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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