raloxifene Side Effects
Also known as: Evista
Analysis of 2,311 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
2,311
Death-Related
155
6.7% of reports
Hospitalizations
632
27.3% 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 155 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 69 |
| CARDIO-RESPIRATORY ARREST | 9 |
| DYSPNOEA | 9 |
| PNEUMONIA | 9 |
| DIARRHOEA | 8 |
| ASTHENIA | 7 |
| COMPLETED SUICIDE | 7 |
| FATIGUE | 7 |
| ATRIAL FIBRILLATION | 6 |
| NAUSEA | 6 |
| RESPIRATORY FAILURE | 6 |
| SEPSIS | 6 |
| ANAEMIA | 5 |
| HEADACHE | 5 |
| PAIN | 5 |
| ASCITES | 4 |
| BACTERAEMIA | 4 |
| CARDIAC DISORDER | 4 |
| DEHYDRATION | 4 |
| DRUG-INDUCED LIVER INJURY | 4 |
Reactions in Hospitalization Reports
Top reactions in 632 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 44 |
| PNEUMONIA | 39 |
| DIARRHOEA | 32 |
| DYSPNOEA | 29 |
| NAUSEA | 27 |
| PULMONARY EMBOLISM | 25 |
| FATIGUE | 23 |
| DIZZINESS | 22 |
| URINARY TRACT INFECTION | 22 |
| ASTHENIA | 21 |
| PAIN | 21 |
| OFF LABEL USE | 20 |
| PYREXIA | 19 |
| BACK PAIN | 18 |
| DECREASED APPETITE | 18 |
| VOMITING | 18 |
| ABDOMINAL PAIN | 17 |
| ATRIAL FIBRILLATION | 17 |
| CONSTIPATION | 17 |
| COUGH | 17 |
Nearby — Related Medications
What the FAERS Data Reveals About raloxifene Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 2,311 voluntary reports linked to raloxifene and its brand equivalents (Evista), spanning 2004 through 2025. Of those, 155 (6.7%) listed death as an outcome and 632 (27.3%) 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, 98% were female and 2% male; age distribution skews toward 65-74, with 540 reports in that bracket. The single most reported reaction is fatigue with 143 submissions, followed by arthralgia and diarrhoea.
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.