Biaxin XL-Pak Side Effects

Generic Name: clarithromycin

Please note - some side effects for Biaxin XL-Pak 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 by Body System - for Healthcare Professionals

Applies to: oral powder for reconstitution; oral tablet; oral tablet, extended release

General

Clarithromycin is generally well tolerated. During clinical trials, most side effects were of a mild and transient nature, and less than 2% up to 4% of patients discontinued clarithromycin therapy due to adverse side effects.

Gastrointestinal

Gastrointestinal side effects have included nausea (up to 12.3%), diarrhea (up to 7.7%), vomiting (up to 7.5%), abdominal pain/discomfort (up to 5%), dyspepsia (up to 3.8%), flatulence (up to 2.4%), and Clostridium difficile associated diarrhea. Anorexia, glossitis, stomatitis, oral moniliasis, pancreatitis, tongue discoloration, tooth discoloration (usually reversible with professional dental cleaning), and vomiting have been reported during postmarketing experience.

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 hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice. In some instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications. Elevated AST /SGOT (greater than 5 times ULN; up to 4%), ALT/SGPT (greater than 5 times ULN; up to 3%), alkaline phosphatase (greater than 5 times ULN; up to 2%), gamma glutamyltransferase (less than 1%), lactate dehydrogenase (less than 1%), and total bilirubin (less than 1%) have been reported. Fulminant hepatic failure has been reported in at least one patient during clarithromycin treatment. Adverse reactions related to hepatic dysfunction have been reported during postmarketing experience.

Nervous system

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

Nervous system side effects have included abnormal taste/taste perversion (up to 16%) and headache (up to 9%). New onset symptoms of myasthenic syndrome and exacerbation of symptoms of myasthenia gravis have been reported. Dizziness, hearing loss, convulsions, tinnitus, tremor, vertigo, and alterations of the sense of smell including smell loss, usually in conjunction with taste perversion or taste loss, have been reported during postmarketing experience.

Hypersensitivity

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.

Hypersensitivity side effects have included allergic reactions ranging from urticaria and mild skin eruptions to rare cases of anaphylaxis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, and toxic epidermal necrolysis during postmarketing experience.

Cardiovascular

Cardiovascular side effects have included QT interval prolongation and ventricular arrhythmias, including ventricular tachycardia and torsade de pointes, during postmarketing experience.

Hematologic

Hematologic side effects have included decreased WBC [less than 1 x 10(9)/L; up to 4%], decreased platelet count [less than 50 x 10(9)/L; up to 4%], decreased hemoglobin (less than 8 g/dL; 3%), and elevated prothrombin time (1%). Thrombocytopenia, leukopenia, neutropenia, and hemorrhage have been reported during postmarketing experience.

Renal

Renal side effects have included elevated BUN (unspecified: 4%; greater than 50 mg/dL: less than 1%), elevated serum creatinine (less than 1%), and acute renal failure. Interstitial nephritis has been reported during postmarketing experience.

Dermatologic

Dermatologic side effects have included rash (3.2%).

Other

Many reports of tablets in the stool occurred in patients with anatomic (including ileostomy or colostomy) or functional gastrointestinal disorders with shortened gastrointestinal transit times.

Other side effects have included infection (2%). The presence of Biaxin(R) XL tablets in the stool has been reported during postmarketing experience.

Psychiatric

Psychiatric side effects have included anxiety, behavioral changes, confusional states, depersonalization, disorientation, hallucinations, insomnia, depression, manic behavior, nightmares, and psychosis during postmarketing experience. These effects usually resolved after discontinuation of clarithromycin.

Metabolic

Metabolic side effects have included hypoglycemia during postmarketing experience; however, some cases occurred in patients receiving oral hypoglycemic agents or insulin.

Musculoskeletal

In some cases, clarithromycin was administered concomitantly with other drugs known to be associated with rhabdomyolysis (such as statins, fibrates, colchicine, or allopurinol).

Musculoskeletal side effects have included myalgia and rhabdomyolysis during postmarketing experience.

Ocular

Ocular side effects have included at least one case of corneal opacities in a patient with AIDS and Mycobacterium avium complex bacteremia. The patient's ocular signs and symptoms resolved upon substitution with azithromycin.

Immunologic

Immunologic side effects have included isolated cases of leukocytoclastic vasculitis.

Respiratory

Respiratory side effects have included laryngismus.

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