clarithromycin Side Effects
Also known as: Biaxin
Analysis of 33,247 adverse event reports submitted to the FDA from 1999 to 2025.
Total Reports
33,247
Death-Related
2,888
8.7% of reports
Hospitalizations
13,190
39.7% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 2,888 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 304 |
| PNEUMONIA | 303 |
| DEATH | 298 |
| DRUG INEFFECTIVE | 274 |
| DYSPNOEA | 231 |
| PYREXIA | 219 |
| SEPSIS | 209 |
| ACUTE KIDNEY INJURY | 169 |
| RESPIRATORY FAILURE | 166 |
| CARDIAC ARREST | 163 |
| MULTIPLE ORGAN DYSFUNCTION SYNDROME | 151 |
| OFF LABEL USE | 149 |
| DIARRHOEA | 147 |
| RENAL FAILURE | 146 |
| MALAISE | 134 |
| VOMITING | 133 |
| COUGH | 120 |
| NAUSEA | 119 |
| THROMBOCYTOPENIA | 116 |
| TOXICITY TO VARIOUS AGENTS | 111 |
Reactions in Hospitalization Reports
Top reactions in 13,190 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DRUG INTERACTION | 1,740 |
| PYREXIA | 1,150 |
| DYSPNOEA | 995 |
| NAUSEA | 982 |
| DRUG INEFFECTIVE | 978 |
| PNEUMONIA | 880 |
| MALAISE | 840 |
| DIARRHOEA | 781 |
| VOMITING | 764 |
| OFF LABEL USE | 716 |
| ACUTE KIDNEY INJURY | 670 |
| HEADACHE | 602 |
| PAIN | 580 |
| ABDOMINAL PAIN | 552 |
| ANAEMIA | 526 |
| COUGH | 512 |
| RASH | 495 |
| WEIGHT DECREASED | 488 |
| CONFUSIONAL STATE | 475 |
| ERYTHEMA | 447 |
Nearby — Related Medications
What the FAERS Data Reveals About clarithromycin Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 33,247 voluntary reports linked to clarithromycin and its brand equivalents (Biaxin), spanning 1999 through 2025. Of those, 2,888 (8.7%) listed death as an outcome and 13,190 (39.7%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 60% were female and 40% male; age distribution skews toward 45-64, with 7,602 reports in that bracket. The single most reported reaction is drug interaction with 2,906 submissions, followed by drug ineffective and nausea.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.