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Clarithromycin Side Effects

Not all side effects for clarithromycin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

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

In addition to its needed effects, some unwanted effects may be caused by clarithromycin. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking clarithromycin:

Less common
  • Cough
  • fever or chills
  • hoarseness
  • lower back or side pain
  • painful or difficult urination
Rare
  • Abdominal or stomach tenderness
  • fever with or without chills
  • nausea and vomiting
  • severe abdominal or stomach cramps and pain
  • shortness of breath
  • skin rash and itching
  • unusual bleeding or bruising
  • watery and severe diarrhea, which may also be bloody
  • yellow eyes or skin
Incidence not known
  • Abdominal or stomach pain
  • anxiety
  • black, tarry stools
  • blistering, peeling, or 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, 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
  • slow heartbeat
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • sudden death
  • swollen glands
  • tightness in the chest
  • unpleasant breath odor
  • unusual behavior
  • unusual tiredness or weakness
  • vomiting of blood
  • wheezing

Some of the side effects that can occur with clarithromycin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Acid or sour stomach
  • belching
  • bloated or full feeling
  • change in sensation of taste
  • diarrhea (mild)
  • excess air or gas in the stomach or intestines
  • headache
  • heartburn
  • indigestion
  • passing gas
  • stomach discomfort, upset, or pain
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
  • mental depression
  • mood or mental changes
  • sensation of spinning
  • shakiness in the legs, arms, hands, or feet
  • skin eruptions
  • sleeplessness
  • sore mouth or tongue
  • swelling or inflammation of the mouth
  • taste loss
  • tongue discoloration
  • tooth discoloration
  • trouble sleeping
  • unable to sleep
  • 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.[Ref]

Nervous system

Deafness was reported mainly in elderly women and was usually reversible.[Ref]

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]

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[Ref]

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]

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[Ref]

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]

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

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]

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]

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

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]

Common (1% to 10%): Dyspnea, rhinitis, increased cough, pharyngitis, asthma
Uncommon (0.1% to 1%): Epistaxis, pulmonary embolism
Frequency not reported: Laryngismus[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]

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