Biaxin Side Effects

Generic Name: clarithromycin

Please note - some side effects for Biaxin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Biaxin - for the Consumer

Biaxin

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 Biaxin:

Abnormal taste; diarrhea; headache; indigestion; nausea; stomach discomfort; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; decreased urination; depression; emotional or mood changes; hallucinations; nightmares; severe diarrhea; severe stomach pain/cramps; trouble sleeping.

Biaxin XL 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 Biaxin XL Extended-Release Tablets:

Abnormal taste; diarrhea; headache; indigestion; nausea; stomach discomfort; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; decreased urination; depression; emotional or mood changes; hallucinations; nightmares; severe diarrhea; severe stomach pain/cramps; trouble sleeping.

Biaxin 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 Biaxin Suspension:

Abnormal taste; diarrhea; headache; indigestion; nausea; stomach discomfort; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; confusion; decreased urination; depression; emotional or mood changes; hallucinations; nightmares; severe diarrhea; severe stomach pain/cramps; trouble sleeping.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Biaxin Side Effects - for the Professional

Biaxin

The majority of side effects observed in clinical trials were of a mild and transient nature. Fewer than 3% of adult patients without mycobacterial infections and fewer than 2% of pediatric patients without mycobacterial infections discontinued therapy because of drug-related side effects. Fewer than 2% of adult patients taking Biaxin XL tablets discontinued therapy because of drug-related side effects.

The most frequently reported events in adults taking Biaxin tablets (clarithromycin tablets, USP) were diarrhea (3%), nausea (3%), abnormal taste (3%), dyspepsia (2%), abdominal pain/discomfort (2%), and headache (2%). In pediatric patients, the most frequently reported events were diarrhea (6%), vomiting (6%), abdominal pain (3%), rash (3%), and headache (2%). Most of these events were described as mild or moderate in severity. Of the reported adverse events, only 1% was described as severe.

The most frequently reported events in adults taking Biaxin XL (Clarithromycin extended-release tablets) were diarrhea (6%), abnormal taste (7%), and nausea (3%). Most of these events were described as mild or moderate in severity. Of the reported adverse events, less than 1% were described as severe.

In the acute exacerbation of chronic bronchitis and acute maxillary sinusitis studies overall gastrointestinal adverse events were reported by a similar proportion of patients taking either Biaxin tablets or Biaxin XL tablets; however, patients taking Biaxin XL tablets reported significantly less severe gastrointestinal symptoms compared to patients taking Biaxin tablets. In addition, patients taking Biaxin XL tablets had significantly fewer premature discontinuations for drug-related gastrointestinal or abnormal taste adverse events compared to Biaxin tablets.

In community-acquired pneumonia studies conducted in adults comparing clarithromycin to erythromycin base or erythromycin stearate, there were fewer adverse events involving the digestive system in clarithromycin-treated patients compared to erythromycin-treated patients (13% vs 32%; p < 0.01). Twenty percent of erythromycin-treated patients discontinued therapy due to adverse events compared to 4% of clarithromycin-treated patients.

In two U.S. studies of acute otitis media comparing clarithromycin to amoxicillin/potassium clavulanate in pediatric patients, there were fewer adverse events involving the digestive system in clarithromycin-treated patients compared to amoxicillin/potassium clavulanate-treated patients (21% vs. 40%, p < 0.001). One-third as many clarithromycin-treated patients reported diarrhea as did amoxicillin/potassium clavulanate-treated patients.

Post-Marketing Experience

Allergic reactions ranging from urticaria and mild skin eruptions to rare cases of anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis have occurred. Other spontaneously reported adverse events include glossitis, stomatitis, oral moniliasis, anorexia, vomiting, pancreatitis, tongue discoloration, thrombocytopenia, leukopenia, neutropenia, and dizziness. There have been reports of tooth discoloration in patients treated with Biaxin. Tooth discoloration is usually reversible with professional dental cleaning. There have been isolated reports of hearing loss, which is usually reversible, occurring chiefly in elderly women. Reports of alterations of the sense of smell, usually in conjunction with taste perversion or taste loss have also been reported.

Transient CNS events including anxiety, behavioral changes, confusional states, convulsions, depersonalization, disorientation, hallucinations, insomnia, depression, manic behavior, nightmares, psychosis, tinnitus, tremor, and vertigo have been reported during post-marketing surveillance. Events usually resolve with discontinuation of the drug.

Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with clarithromycin. This hepatic dysfunction may be severe and is usually reversible. In very rare instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications.

There have been rare reports of hypoglycemia, some of which have occurred in patients taking oral hypoglycemic agents or insulin.

There have been post-marketing reports of Biaxin XL tablets in the stool, many of which have occurred in patients with anatomic (including ileostomy or colostomy) or functional gastrointestinal disorders with shortened GI transit times.

As with other macrolides, clarithromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes.

There have been reports of interstitial nephritis coincident with clarithromycin use.

There have been post-marketing reports of colchicine toxicity with concomitant use of clarithromycin and colchicine, especially in the elderly, some of which occurred in patients with renal insufficiency. Deaths have been reported in some such patients.

Changes in Laboratory Values

Changes in laboratory values with possible clinical significance were as follows:

Elevated SGPT (ALT) < 1%; SGOT (AST) < 1%; GGT < 1%; alkaline phosphatase< 1%; LDH < 1%; total bilirubin < 1%

Decreased WBC < 1%; elevated prothrombin time 1%

Elevated BUN 4%; elevated serum creatinine < 1%

GGT, alkaline phosphatase, and prothrombin time data are from adult studies only.

Side Effects by Body System

General

Clarithromycin is generally well tolerated. In large studies, 3% to 4% of patients discontinued clarithromycin therapy due to adverse side effects.

Gastrointestinal

Gastrointestinal side effects are the most common side effects of clarithromycin and include abdominal discomfort, dyspepsia, nausea, and diarrhea in 2% to 3% of patients. Anorexia and vomiting have been reported in postmarketing studies.

Nervous system

Nervous system side effects are unusual. An alteration in taste may occur in 1% to 2% of patients during clarithromycin therapy. Headache, depression, and dizziness have been reported rarely. Myasthenic syndrome has been described in an isolated case report.

Hepatic

Clarithromycin-induced hepatotoxicity is rare and typically associated with higher dosages (1 to 2 grams/day) and high serum drug concentrations. The enzyme elevation pattern is usually cholestatic with minimal elevations of SGOT and SGPT.

In patients with liver disease, frequent monitoring of liver function test during prolonged clarithromycin therapy is recommended.

Hepatic side effects have included mild increases in liver function tests and hepatocellular and/or cholestatic hepatitis. Fulminant hepatic failure has been reported in at least one patient during clarithromycin treatment. Pancreatitis has also been reported.

Hypersensitivity

Hypersensitivity reactions including rash have been reported in 1% to 2% of patients. Postmarketing studies have reported allergic reactions ranging from urticaria and mild skin eruptions to rare cases of anaphylaxis, Stevens-Johnson syndrome, and toxic epidermal necrolysis.

A 92-year-old female admitted for heart failure and a right upper lobe infiltrate was started on clarithromycin 500 mg. The following day, the clarithromycin was discontinued and intravenous antibiotics were initiated due to persisting fever. She received only one dose of clarithromycin. On day 6 of the hospitalization, the patient was afebrile, intravenous antibiotics were stopped, and clarithromycin was again started. Two hours following the dose, the patient developed swelling in her lips, jaw, tongue, mouth, and face. The patient was given diphenhydramine and the clarithromycin was discontinued. She was discharged the following day.

Ocular

A single case of corneal opacities has been associated with the use of clarithromycin in a patient with AIDS and M. avium complex bacteremia. The patient's ocular signs and symptoms resolved upon substitution with azithromycin.

Psychiatric

Psychiatric side effects have been reported in postmarketing experience and include anxiety, behavioral changes, confusional states, depersonalization, disorientation, hallucinations, insomnia, manic behavior, nightmares, psychosis, tinnitus, tremor, and vertigo. These effects usually resolve after discontinuation of clarithromycin.

Immunologic

Immunologic side effects have been extremely rare and include isolated cases of leukocytoclastic vasculitis.

Cardiovascular

Cardiovascular side effects including QT interval prolongation, ventricular tachycardia, and torsade de pointes have been reported rarely.

Renal

Renal side effects reported in postmarketing studies have included elevated BUN (4%), elevated serum creatinine (less than 1%), and acute renal failure.

Other

Other side effects reported in postmarketing study have included laryngismus, glossitis, stomatitis, oral moniliasis, tongue and tooth discoloration, reversible hearing loss, and alterations of the sense of smell.

The hearing loss that has been reported was usually reversible and occurred mainly in elderly women.

Hematologic

Hematologic side effects include decreased WBC (< 1%) and elevated prothrombin time (1%). Thrombocytopenia, leukopenia, and neutropenia have also been reported in postmarketing studies.

Endocrine

Endocrine side effects are extremely rare. Hypoglycemia has been reported in postmarketing studies; however, some cases occurred in patients receiving oral hypoglycemic agents or insulin.

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