Note: This document contains side effect information about clarithromycin. Some of the dosage forms listed on this page may not apply to the brand name Biaxin XL.
Applies to clarithromycin: oral powder for suspension, oral tablet, oral tablet extended release
Along with its needed effects, clarithromycin (the active ingredient contained in Biaxin XL) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking clarithromycin:
Incidence not known
Some side effects of clarithromycin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to clarithromycin: oral powder for reconstitution, oral tablet, oral tablet extended release
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.
Deafness was reported mainly in elderly women and was usually reversible.
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
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
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.
These side effects are specific to the IV formulation.
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
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
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.
Common (1% to 10%): Anaphylactoid reaction
Uncommon (0.1% to 1%): Hypersensitivity, allergic reactions
Postmarketing reports: Anaphylactic reaction, angioedema
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.
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
Decreased WBC (less than 1 x 10/L), platelet count (less than 50 x 10/L), and hemoglobin (less than 8 g/dL) were reported in up to 4%, up to 4%, and 3% of patients, respectively.
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
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
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
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.
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.
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
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.
Common (1% to 10%): Increased alkaline phosphatase
Uncommon (0.1% to 1%): Anorexia, decreased appetite, increased blood LDH
Postmarketing reports: Hypoglycemia
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.
Common (1% to 10%): Dyspnea, rhinitis, increased cough, pharyngitis, asthma
Uncommon (0.1% to 1%): Epistaxis, pulmonary embolism
Frequency not reported: Laryngismus
Common (1% to 10%): Conjunctivitis
Uncommon (0.1% to 1%): Photophobia
Very rare (less than 0.01%): Uveitis
Frequency not reported: Corneal opacities
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.
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
Elevated BUN (greater than 50 mg/dL) was reported in less than 1% of patients.
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.
Uncommon (0.1% to 1%): Vaginal infection
Postmarketing reports: Abnormal urine color (associated with hepatic failure), dysuria
Rare (0.01% to 0.1%): Leukocytoclastic vasculitis
Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.
Source: Drugs.com Biaxin Xl