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Clarithromycin er

Generic Name: clarithromycin (kla RITH roe MYE sin)
Brand Names: Biaxin, Biaxin XL
Clarithromycin is used to treat bacterial infections affecting the skin and respiratory system. Learn about side effects, interactions and indications.
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Drug Information:
Clarithromycin is a macrolide antibiotic that fights bacteria in your body. Clarithromycin is used to treat many different types of bacterial infections affecting the skin and respiratory system. Clarithromycin is also used together with other medicines to treat stomach ulcers caused by Helicobacter pylori. Take clarithromycin for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. This medicine will not treat a viral infection such as the common cold or flu. Learn more

Clarithromycin er Side Effects

Clarithromycin Side Effects

In Summary

Commonly reported side effects of clarithromycin include: dysgeusia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to clarithromycin: oral powder for suspension, oral tablet, oral tablet extended release

Along with its needed effects, clarithromycin 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:

Less common

  • Cough
  • fever or chills
  • hoarseness
  • lower back or side pain
  • painful or difficult urination

Rare

  • Fever with or without chills
  • nausea and vomiting
  • severe stomach cramps and pain
  • skin rash and itching
  • stomach tenderness
  • unusual bleeding or bruising
  • watery and severe diarrhea, which may also be bloody
  • yellow eyes or skin

Incidence not known

  • Anxiety
  • black, tarry stools
  • blistering, peeling, loosening of the skin
  • blurred vision
  • chest pain or discomfort
  • clay-colored stools
  • confusion about identity, place, and time
  • cool, pale skin
  • dark urine
  • depression
  • difficulty with swallowing
  • dizziness
  • fainting
  • fast, slow, pounding, or irregular heartbeat or pulse
  • feeling of unreality
  • feeling that others are watching you or controlling your behavior
  • feeling that others can hear your thoughts
  • feeling, seeing, or hearing things that are not there
  • hives
  • increased hunger
  • irregular heartbeat
  • joint or muscle pain
  • light-colored stools
  • loss of appetite
  • nightmares
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • recurrent fainting
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness, swelling, or soreness of the tongue
  • seizures
  • sense of detachment from self or body
  • severe mood or mental changes
  • shakiness
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach pain
  • sudden death
  • swollen glands
  • tightness in the chest
  • unpleasant breath odor
  • unusual behavior
  • unusual tiredness or weakness
  • vomiting of blood

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:

Less common

  • Belching
  • bloated or full feeling
  • change in sensation of taste
  • excess air or gas in the stomach or intestines
  • headache
  • heartburn
  • indigestion
  • mild diarrhea
  • passing gas

Incidence not known

  • Alterations of sense of smell
  • continuing ringing or buzzing or other unexplained noise in the ears
  • feeling of constant movement of self or surroundings
  • hearing loss
  • lightheadedness
  • loss of taste
  • mood or mental changes
  • sensation of spinning
  • shakiness in the legs, arms, hands, or feet
  • skin eruptions
  • sore mouth or tongue
  • swelling or inflammation of the mouth
  • tongue discoloration
  • tooth discoloration
  • trouble sleeping
  • weight loss

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.

Nervous system

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

Gastrointestinal

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.

Local

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

Hepatic

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.

Hypersensitivity

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.

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

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.

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

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

Other

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.

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.

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

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.

Common (1% to 10%): Increased alkaline phosphatase

Uncommon (0.1% to 1%): Anorexia, decreased appetite, increased blood LDH

Postmarketing reports: Hypoglycemia

Respiratory

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

Ocular

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.

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

Elevated BUN (greater than 50 mg/dL) was reported in less than 1% of patients.

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

Immunologic

Rare (0.01% to 0.1%): Leukocytoclastic vasculitis

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Clarithromycin Er