Note: This document contains side effect information about clarithromycin. Some dosage forms listed on this page may not apply to the brand name Biaxin XL.
Applies to clarithromycin: oral clarithromycin combinations, oral for suspension, oral tablets.
Side effects include:
GI adverse effects (diarrhea, nausea, abnormal taste, dyspepsia, abdominal pain) and headache.
For Healthcare Professionals
Applies to clarithromycin: oral powder for reconstitution, oral tablet, oral tablet extended release.
General
The most common side effects were abdominal pain/discomfort, diarrhea, nausea, vomiting, and dysgeusia/taste perversion.
In immunocompromised patients treated with higher doses of this drug (1 to 2 g/day), the most common side effects were nausea, vomiting, taste perversion, abdominal pain, diarrhea, rash, flatulence, headache, constipation, hearing disturbance, increased AST, and increased ALT.[Ref]
Nervous system
Very common (10% or more): Dysgeusia/taste perversion (up to 16%)
Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Loss of consciousness, dyskinesia, somnolence, hearing impaired, tinnitus, tremor, vertigo
Frequency not reported: New onset of symptoms of myasthenic syndrome, exacerbation of symptoms of myasthenia gravis, hearing disturbance, muzziness
Postmarketing reports: Convulsions, ageusia, parosmia/smell perversion, anosmia, paresthesia, deafness, hyperkinesia[Ref]
Deafness was reported mainly in elderly women and was usually reversible.[Ref]
Gastrointestinal
The incidence of dry mouth was similar for patients treated with 1 to 2 g/day, but was generally about 3 to 4 times as frequent for those treated with 4 g/day.
Severity of pseudomembranous colitis has ranged from mild to life-threatening.
Tooth discoloration was usually reversible with professional dental cleaning after the drug was stopped.[Ref]
Very common (10% or more): Nausea (up to 12.3%)
Common (1% to 10%): Diarrhea, vomiting, abdominal pain/discomfort, dyspepsia/heartburn, flatulence, oral candidiasis/moniliasis, constipation
Uncommon (0.1% to 1%): Glossitis, stomatitis, esophagitis, gastroesophageal reflux disease, gastritis, proctalgia, abdominal distension, dry mouth, eructation, gastroenteritis, gastrointestinal hemorrhage, bleeding gums, bloodstained stools
Frequency not reported: Clostridium difficile-associated diarrhea (ranging from mild diarrhea to fatal colitis), pancreatitis
Postmarketing reports: Acute pancreatitis, tongue discoloration, tooth discoloration, pseudomembranous colitis, enteritis[Ref]
Local
Very common (10% or more): Injection site phlebitis
Common (1% to 10%): Injection site pain, injection site inflammation, tenderness at site of administration
Frequency not reported: Vessel puncture site pain
These side effects are specific to the IV formulation.
Hepatic
Elevated AST (greater than 5 times the upper limit of normal [5 x ULN]) and ALT (greater than 5 x ULN) were reported in up to 4% and up to 3% of patients, respectively.
Hepatic dysfunction (sometimes severe and usually reversible), including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice have been reported. In some instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases (e.g., preexisting liver disease) and/or concomitant medications (e.g., hepatotoxic agents).
Drug-induced hepatotoxicity was rare and typically associated with higher doses (1 to 2 g/day) and high serum drug levels. The enzyme elevation pattern was usually cholestatic with minimal elevations of AST and ALT.[Ref]
Common (1% to 10%): Elevated AST, elevated ALT, abnormal liver function test
Uncommon (0.1% to 1%): Cholestasis, hepatitis (symptoms included anorexia, jaundice, dark urine, pruritus, tender abdomen), increased blood bilirubin, elevated GGT, elevated direct bilirubin, hepatic dysfunction (including increased liver enzymes), hepatitis and cholestasis with or without jaundice
Frequency not reported: Hepatocellular and/or cholestatic hepatitis (with or without jaundice), drug-induced hepatotoxicity, fulminant hepatic failure
Postmarketing reports: Hepatic failure, hepatocellular jaundice, adverse reactions related to hepatic dysfunction, abnormal hepatic function, liver abnormalities[Ref]
Hypersensitivity
Common (1% to 10%): Anaphylactoid reaction
Uncommon (0.1% to 1%): Hypersensitivity, allergic reactions
Postmarketing reports: Anaphylactic reaction, angioedema[Ref]
Allergic reactions have ranged from urticaria and mild skin eruptions to rare cases of anaphylaxis.
A 92-year-old female admitted for heart failure and a right upper lobe infiltrate was started on clarithromycin 500 mg. The following day, this drug was discontinued and IV antibiotics were initiated due to persisting fever. She received only 1 dose of this drug. On day 6 of the hospitalization, the patient was afebrile, IV antibiotics were stopped, and this drug was again started. Two hours after 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.[Ref]
Cardiovascular
Common (1% to 10%): Vasodilation, phlebitis
Uncommon (0.1% to 1%): ECG QT prolonged, cardiac arrest, atrial fibrillation, extrasystoles, palpitations
Rare (0.01% to 0.1%): Arrhythmia
Frequency not reported: QT interval prolongation
Postmarketing reports: Ventricular arrhythmia, ventricular tachycardia, torsades de pointes, hemorrhage[Ref]
Hematologic
Decreased WBC (less than 1 x 10[9]/L), platelet count (less than 50 x 10[9]/L), and hemoglobin (less than 8 g/dL) were reported in up to 4%, up to 4%, and 3% of patients, respectively.[Ref]
Common (1% to 10%): Decreased WBC, decreased platelet count, decreased hemoglobin
Uncommon (0.1% to 1%): Leukopenia, neutropenia, thrombocythemia, eosinophilia, increased prothrombin time
Frequency not reported: Granulocytopenia, reduction in prothrombin time
Postmarketing reports: Thrombocytopenia, agranulocytosis, prolonged prothrombin time, decreased WBC count, increased INR[Ref]
Dermatologic
Common (1% to 10%): Rash, hyperhidrosis, pruritus
Uncommon (0.1% to 1%): Urticaria, dermatitis bullous, maculopapular rash, cellulitis, pustular rash (non-urticarial), stained fingernails
Postmarketing reports: Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schonlein purpura, acne, erysipelas, erythrasma[Ref]
Other
Many reports of extended-release tablets in the stool occurred in patients with anatomic (including ileostomy or colostomy) or functional gastrointestinal disorders with shortened gastrointestinal transit times. In several reports, tablet residues occurred in the context of diarrhea.
Colchicine toxicity has been reported with concomitant use of this drug and colchicine, especially in the elderly; some occurred in patients with renal dysfunction. Death occurred in some such patients.[Ref]
Common (1% to 10%): Infection, candidiasis, pyrexia/fever, asthenia
Uncommon (0.1% to 1%): Malaise, chest pain, chills, fatigue, thirst, abnormal albumin globulin ratio, body aches and pains, flushing, accidental injury, flu syndrome
Postmarketing reports: Otitis media, extended-release tablets in the stool, colchicine toxicity[Ref]
Psychiatric
The incidence of insomnia was similar for patients treated with 1 to 2 g/day, but was generally about 3 to 4 times as frequent for those treated with 4 g/day.
Psychotic disorder, confusional state, depersonalization, depression, disorientation, manic behavior, hallucination, abnormal behavior, and/or abnormal dreams usually resolved after the drug was stopped.[Ref]
Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Anxiety, nervousness, screaming, depression, sleep disturbance
Frequency not reported: Behavioral changes, nightmares, psychosis
Postmarketing reports: Psychotic disorder, confusional state, depersonalization, disorientation, hallucination, depression, manic behavior, abnormal behavior, abnormal dreams[Ref]
Metabolic
Increased alkaline phosphatase (greater than 5 x ULN) was reported in up to 2% of patients.
Hypoglycemia has been reported in patients receiving oral hypoglycemic agents or insulin.[Ref]
Common (1% to 10%): Increased alkaline phosphatase
Uncommon (0.1% to 1%): Anorexia, decreased appetite, increased blood LDH
Postmarketing reports: Hypoglycemia[Ref]
Respiratory
Common (1% to 10%): Dyspnea, rhinitis, increased cough, pharyngitis, asthma
Uncommon (0.1% to 1%): Epistaxis, pulmonary embolism
Frequency not reported: Laryngismus[Ref]
The incidence of dyspnea was similar for patients treated with 1 to 2 g/day, but was generally about 3 to 4 times as frequent for those treated with 4 g/day.[Ref]
Ocular
Common (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Photophobia
Very rare (less than 0.01%): Uveitis
Frequency not reported: Corneal opacities[Ref]
Uveitis was reported primarily in patients treated with concomitant rifabutin; most cases were reversible.
A case of corneal opacities was reported in a patient with AIDS and Mycobacterium avium complex bacteremia. The patient's ocular signs and symptoms resolved upon substitution with azithromycin.[Ref]
Renal
Uncommon (0.1% to 1%): Elevated BUN, elevated serum creatinine, increased blood urea, increased blood creatinine
Frequency not reported: Acute renal failure
Postmarketing reports: Interstitial nephritis, renal failure[Ref]
Elevated BUN (greater than 50 mg/dL) was reported in less than 1% of patients.[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Myalgia, muscle spasms, nuchal rigidity, musculoskeletal stiffness, arthralgia, back pain
Postmarketing reports: Myopathy, rhabdomyolysis
In some cases of rhabdomyolysis, this drug was coadministered with statins, fibrates, colchicine, or allopurinol.
Genitourinary
Uncommon (0.1% to 1%): Vaginal infection
Postmarketing reports: Abnormal urine color (associated with hepatic failure), dysuria[Ref]
Immunologic
Rare (0.01% to 0.1%): Leukocytoclastic vasculitis[Ref]
