Biaxin Side Effects
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Biaxin Side Effects
The majority of Biaxin side effects observed in Biaxin 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 Biaxin therapy because of drug-related side effects.
The most frequently reported Biaxin side effects in adults were:
- diarrhea (3%)
- nausea (3%)
- abnormal taste (3%)
- dyspepsia (2%)
- abdominal pain/discomfort (2%)
- headache (2%).
In pediatric patients, the most frequently Biaxin side effects were:
- diarrhea (6%)
- vomiting (6%)
- abdominal pain (3%)
- rash (3%)
- headache (2%).
Most of these Biaxin side effects were described as mild or moderate in severity. Of the reported Biaxin side effects, only 1% was described as severe.
In pneumonia studies conducted in adults comparing Biaxin (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 side effects compared to 4% of Biaxin (clarithromycin)-treated patients.
In two U.S. studies of acute otitis media comparing Biaxin (clarithromycin) to amoxicillin/potassium clavulanate in pediatric patients, there were fewer adverse events involving the digestive system in Biaxin (clarithromycin)-treated patients compared to amoxicillin/potassium clavulanate-treated patients (21% vs. 40%, p<0.001). One-third as many Biaxin (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 and Stevens-Johnson syndrome have occurred as Biaxin (clarithromycin) side effects. Other spontaneously reported Biaxin (clarithromycin) side effects include glossitis, stomatitis, oral moniliasis, vomiting, tongue discoloration, thrombocytopenia, leukopenia, neutropenia, and dizziness. There have been reports of tooth discoloration in patients treated with Biaxin (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 have also been reported.
Transient CNS Biaxin side effects including anxiety, behavioral changes, confusional states, depersonalization, disorientation, hallucinations, insomnia, manic behavior, nightmares, psychosis, tinnitus, tremor and vertigo have been reported during post-marketing surveillance. Events usually resolve quickly 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 Biaxin (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.
As with other macrolides, Biaxin (clarithromycin) has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes.
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