"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(Generic versions may still be available.)
Zagam Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Zagam (sparfloxacin) is an antibiotic used to treat various types of bacterial infections. The brand name Zagam is discontinued, but generic versions may be available. Common side effects of Zagam (sparfloxacin) include:
- ringing in the ears
- increased sensitivity of the skin to sunlight
- abdominal pain
- changes in taste
- elevated blood pressure, and
- heart rhythm disorders
The recommended daily dose of Zagam in patients with normal renal function is two 200-mg tablets taken on the first day as a loading dose. Thereafter, one 200-mg tablet should be taken every 24 hours for a total of 10 days of therapy (11 tablets). Zagam may interact with antacids containing magnesium or aluminum, sucralfate, vitamin or mineral supplements containing iron or zinc, heart medicines, terfenadine, astemizole, tricyclic antidepressants, phenothiazines, erythromycin, or cisapride. Tell your doctor all medications and supplements you use. It is unknown if Zagam will harm a fetus. Tell your doctor if you are pregnant or could become pregnant during treatment. This drug passes into breast milk and may harm a nursing infant. It may affect bone development. Consult your doctor before breastfeeding.
Our Zagam (sparfloxacin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zagam FDA Prescribing Information: Side Effects
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 entire FDA prescribing information for Zagam (Sparfloxacin)
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.
Find out what women really need.