ranitidine Side Effects
Also known as: Zantac
Analysis of 197,405 adverse event reports submitted to the FDA from 1999 to 2025.
Total Reports
197,405
Death-Related
15,440
7.8% of reports
Hospitalizations
25,953
13.1% of reports
Top Indication
Dyspepsia
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 15,440 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 2,248 |
| PANCREATIC CARCINOMA | 1,995 |
| HEPATIC CANCER | 1,871 |
| NEOPLASM MALIGNANT | 1,623 |
| OESOPHAGEAL CARCINOMA | 1,456 |
| GASTRIC CANCER | 1,233 |
| LUNG NEOPLASM MALIGNANT | 1,139 |
| COLORECTAL CANCER | 1,013 |
| INCORRECT DOSE ADMINISTERED | 971 |
| BLADDER CANCER | 883 |
| OFF LABEL USE | 815 |
| PNEUMONIA | 791 |
| RENAL CANCER | 700 |
| DIARRHOEA | 684 |
| INJURY | 651 |
| FATIGUE | 625 |
| NAUSEA | 613 |
| VOMITING | 608 |
| PAIN | 598 |
| ASTHENIA | 536 |
Reactions in Hospitalization Reports
Top reactions in 25,953 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| NAUSEA | 2,042 |
| DIARRHOEA | 1,967 |
| DYSPNOEA | 1,934 |
| VOMITING | 1,870 |
| PNEUMONIA | 1,740 |
| FATIGUE | 1,719 |
| PAIN | 1,521 |
| OFF LABEL USE | 1,492 |
| PYREXIA | 1,404 |
| ASTHENIA | 1,390 |
| HEADACHE | 1,364 |
| INCORRECT DOSE ADMINISTERED | 1,269 |
| MALAISE | 1,236 |
| DIZZINESS | 1,235 |
| DRUG INEFFECTIVE | 1,234 |
| ACUTE KIDNEY INJURY | 1,226 |
| FALL | 1,169 |
| ABDOMINAL PAIN | 1,108 |
| ARTHRALGIA | 1,103 |
| HYPERTENSION | 1,092 |
Nearby — Related Medications
What the FAERS Data Reveals About ranitidine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 197,405 voluntary reports linked to ranitidine and its brand equivalents (Zantac), spanning 1999 through 2025. Of those, 15,440 (7.8%) listed death as an outcome and 25,953 (13.1%) involved hospitalization. The most common indication reported alongside adverse events was Dyspepsia.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 52% were female and 48% male; age distribution skews toward 45-64, with 43,800 reports in that bracket. The single most reported reaction is breast cancer with 24,853 submissions, followed by prostate cancer and colorectal cancer.
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.