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Clarithromycin (Clarithromycin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The majority of side effects observed in clinical trials were of a mild and transient nature. Fewer than 3% of adult patients without mycobacterial infections and fewer than 2% of pediatric patients without mycobacterial infections discontinued therapy because of drug-related side effects. Fewer than 2% of adult patients taking clarithromycin extended-release tablets discontinued therapy because of drug-related side effects

The most frequently reported events in adults taking clarithromycin extended-release tablets, were diarrhea (3%), nausea (3%), abnormal taste (3%), dyspepsia (2%), abdominal pain/discomfort (2%), and headache (2%). In pediatric patients, the most frequently reported events were diarrhea (6%), vomiting (6%), abdominal pain (3%), rash (3%), and headache (2%). Most of these events were described as mild or moderate in severity. Of the reported adverse events, only 1% was described as severe.

The most frequently reported events in adults taking clarithromycin extended-release tablets were diarrhea (6%), abnormal taste (7%), and nausea (3%). Most of these events were described as mild or moderate in severity. Of the reported adverse events, less than 1% were described as severe.

In the acute exacerbation of chronic bronchitis and acute maxillary sinusitis studies overall gastrointestinal adverse events were reported by a similar proportion of patients taking either clarithromycin tablets or clarithromycin extended-release tablets; however, patients taking clarithromycin extended-release tablets reported significantly less severe gastrointestinal symptoms compared to patients taking clarithromycin tablets. In addition, patients taking clarithromycin extended-release tablets had significantly fewer premature discontinuations for drug-related gastrointestinal or abnormal taste adverse events compared to clarithromycin tablets.

In community-acquired pneumonia studies conducted in adults comparing clarithromycin to erythromycin base or erythromycin stearate, there were fewer adverse events involving the digestive system in clarithromycin-treated patients compared to erythromycin-treated patients (13% vs 32%; p < 0.01). Twenty percent of erythromycin-treated patients discontinued therapy due to adverse events compared to 4% of clarithromycin-treated patients.

In two U.S. studies of acute otitis media comparing clarithromycin to amoxicillin/potassium clavulanate in pediatric patients, there were fewer adverse events involving the digestive system in clarithromycin-treated patients compared to amoxicillin/potassium clavulanate-treated patients (21% vs. 40%, p < 0.001). One-third as many clarithromycin-treated patients reported diarrhea as did amoxicillin/potassium clavulanate-treated patients.

Post-Marketing Experience

Allergic reactions ranging from urticaria and mild skin eruptions to rare cases of anaphylaxis, Stevens-Johnson syndrome and toxic epidermal necrolysis have occurred. Other spontaneously reported adverse events include glossitis, stomatitis, oral moniliasis, anorexia, vomiting, pancreatitis, tongue discoloration, thrombocytopenia, leukopenia, neutropenia, and dizziness. There have been reports of tooth discoloration in patients treated with clarithromycin. Tooth discoloration is usually reversible with professional dental cleaning. There have been isolated reports of hearing loss, which is usually reversible, occurring chiefly in elderly women. Reports of alterations of the sense of smell, usually in conjunction with taste perversion or taste loss have also been reported.

Transient CNS events including anxiety, behavioral changes, confusional states, convulsions, depersonalization, disorientation, hallucinations, insomnia, manic behavior, nightmares, psychosis, tinnitus, tremor, and vertigo have been reported during post-marketing surveillance. Events usually resolve with discontinuation of the drug.

Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been infrequently reported with clarithromycin. This hepatic dysfunction may be severe and is usually reversible. In very rare instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications.

There have been rare reports of hypoglycemia, some of which have occurred in patients taking oral hypoglycemic agents or insulin.

There have been postmarketing reports of clarithromycin extended-release tablets in the stool, many of which have occurred in patients with anatomic (including ileostomy or colostomy) or functional gastrointestinal disorders with shortened GI transit times.

As with other macrolides, clarithromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes.

There have been reports of interstitial nephritis coincident with clarithromycin use.

Changes in Laboratory Values

Changes in laboratory values with possible clinical significance were as follows:

Hepatic

elevated SGPT (ALT) < 1%; SGOT (AST) < 1%; GGT < 1%; alkaline phosphatase < 1%; LDH < 1%; total bilirubin < 1%

Hematologic

decreased WBC < 1%; elevated prothrombin time 1%

Renal

elevated BUN 4%; elevated serum creatinine < 1%

GGT, alkaline phosphatase, and prothrombin time data are from adult studies only.



REPORTS OF SUSPECTED CLARITHROMYCIN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Clarithromycin. The information is not vetted and should not be considered as verified clinical evidence.

Possible Clarithromycin side effects / adverse reactions in 78 year old female

Reported by a physician from United States on 2011-07-11

Patient: 78 year old female weighing 55.0 kg (121.0 pounds)

Reactions: Atelectasis, Gastrointestinal Haemorrhage, Rhabdomyolysis, Dyslipidaemia, Osteoporosis, Dizziness Postural, Tricuspid Valve Incompetence, Chronic Obstructive Pulmonary Disease, Hypomagnesaemia, Thyroid Mass, Erosive Oesophagitis, Renal Failure Acute, Type 2 Diabetes Mellitus, Peptic Ulcer, Helicobacter Infection, Dehydration, Mitral Valve Incompetence, Aortic Valve Incompetence, Hypertension

Adverse event resulted in: hospitalization

Suspect drug(s):
Zocor
    Administration route: Oral
    Indication: Coronary Artery Disease
    End date: 2010-05-01

Zocor
    Administration route: Oral
    Indication: Hyperlipidaemia
    End date: 2010-05-01

Clarithromycin

Other drugs received by patient: Verapamil



Possible Clarithromycin side effects / adverse reactions in 74 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-03

Patient: 74 year old female

Reactions: Torsade DE Pointes, Nasopharyngitis, Long QT Syndrome

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Probucol
    Dosage: unk
    Administration route: Oral

Disopyramide
    Dosage: unk
    Administration route: Oral

Metildigoxin
    Administration route: Oral

Metoprolol Tartrate
    Dosage: unk
    Administration route: Oral
    Indication: Atrial Fibrillation

Clarithromycin
    Dosage: unk
    Start date: 2011-01-01



Possible Clarithromycin side effects / adverse reactions in 59 year old male

Reported by a physician from Sweden on 2011-10-03

Patient: 59 year old male

Reactions: Diarrhoea, Pancytopenia, Respiratory Distress

Adverse event resulted in: death, life threatening event, hospitalization

Suspect drug(s):
Levofloxacin
    Indication: Atypical Mycobacterial Infection
    Start date: 2011-05-19
    End date: 2011-05-30

Colchicine
    Administration route: Oral
    Indication: Gout
    Start date: 2011-04-27
    End date: 2011-05-30

Clarithromycin
    Administration route: Oral
    Indication: Atypical Mycobacterial Infection
    Start date: 2011-05-19
    End date: 2011-05-30

Amikacin Sulfate
    Indication: Atypical Mycobacterial Infection
    Start date: 2011-05-19
    End date: 2011-05-30

Other drugs received by patient: Prednisolone; Fluconazole; Warfarin Sodium; Lyrica



See index of all Clarithromycin side effect reports >>

Drug label data at the top of this Page last updated: 2008-08-08

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