leuprolide Side Effects
Also known as: Lupron
Analysis of 1,385 adverse event reports submitted to the FDA from 2005 to 2025.
Total Reports
1,385
Death-Related
119
8.6% of reports
Hospitalizations
457
33.0% 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 119 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 29 |
| DRUG INEFFECTIVE | 18 |
| MALIGNANT NEOPLASM PROGRESSION | 16 |
| ACUTE KIDNEY INJURY | 10 |
| ANAEMIA | 10 |
| METASTASES TO BONE | 9 |
| PNEUMONIA | 8 |
| PROSTATE CANCER | 8 |
| HYPOTENSION | 7 |
| DISEASE PROGRESSION | 6 |
| FATIGUE | 6 |
| FEBRILE NEUTROPENIA | 6 |
| METASTASES TO LIVER | 6 |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | 6 |
| RESPIRATORY FAILURE | 6 |
| DYSPNOEA | 5 |
| FALL | 5 |
| GASTROENTERITIS NOROVIRUS | 5 |
| OPHTHALMIC HERPES ZOSTER | 5 |
| PAIN | 5 |
Reactions in Hospitalization Reports
Top reactions in 457 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FEBRILE NEUTROPENIA | 37 |
| DRUG INEFFECTIVE | 35 |
| NAUSEA | 27 |
| ACUTE KIDNEY INJURY | 26 |
| FATIGUE | 26 |
| VOMITING | 24 |
| OFF LABEL USE | 23 |
| ANAEMIA | 22 |
| FALL | 20 |
| HYPOTENSION | 19 |
| THROMBOCYTOPENIA | 19 |
| MALIGNANT NEOPLASM PROGRESSION | 18 |
| ASTHENIA | 17 |
| DRUG DEPENDENCE | 17 |
| DYSPNOEA | 17 |
| HYPERTENSION | 17 |
| INTENTIONAL PRODUCT MISUSE | 17 |
| RESPIRATORY DEPRESSION | 17 |
| DIARRHOEA | 16 |
| PNEUMOCYSTIS JIROVECII PNEUMONIA | 16 |
Nearby — Related Medications
What the FAERS Data Reveals About leuprolide Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,385 voluntary reports linked to leuprolide and its brand equivalents (Lupron), spanning 2005 through 2025. Of those, 119 (8.6%) listed death as an outcome and 457 (33.0%) 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, 43% were female and 57% male; age distribution skews toward 65-74, with 268 reports in that bracket. The single most reported reaction is drug ineffective with 106 submissions, followed by fatigue and off label use.
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.