butorphanol Side Effects
Also known as: Stadol
Analysis of 318 adverse event reports submitted to the FDA from 2002 to 2025.
Total Reports
318
Death-Related
7
2.2% of reports
Hospitalizations
48
15.1% of reports
Top Indication
Migraine
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 7 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| CARDIAC FAILURE | 2 |
| PNEUMONIA | 2 |
| PNEUMONITIS | 2 |
| ABDOMINAL DISTENSION | 1 |
| BRAIN CONTUSION | 1 |
| BRAIN HERNIATION | 1 |
| BRAIN OEDEMA | 1 |
| BURNING SENSATION | 1 |
| CAROTID ARTERY THROMBOSIS | 1 |
| CEREBRAL HAEMORRHAGE | 1 |
| CEREBRAL INFARCTION | 1 |
| COMA | 1 |
| DEPENDENCE | 1 |
| DIZZINESS | 1 |
| DRUG INEFFECTIVE | 1 |
| DYSGEUSIA | 1 |
| EXPOSURE DURING PREGNANCY | 1 |
| LIVE BIRTH | 1 |
| MULTI-ORGAN FAILURE | 1 |
| NASAL DISORDER | 1 |
Reactions in Hospitalization Reports
Top reactions in 48 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| DYSPNOEA | 8 |
| ANXIETY | 7 |
| PAIN | 7 |
| FATIGUE | 6 |
| HEADACHE | 6 |
| NAUSEA | 6 |
| PNEUMONIA | 6 |
| DEPRESSION | 5 |
| HYPOAESTHESIA | 5 |
| CEREBROVASCULAR ACCIDENT | 4 |
| DRUG HYPERSENSITIVITY | 4 |
| FALL | 4 |
| MUSCULAR WEAKNESS | 4 |
| WEIGHT DECREASED | 4 |
| ABDOMINAL PAIN | 3 |
| ARTHRALGIA | 3 |
| BACK PAIN | 3 |
| CARDIAC DISORDER | 3 |
| CHEST PAIN | 3 |
| DIARRHOEA | 3 |
Nearby — Related Medications
What the FAERS Data Reveals About butorphanol Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 318 voluntary reports linked to butorphanol and its brand equivalents (Stadol), spanning 2002 through 2025. Of those, 7 (2.2%) listed death as an outcome and 48 (15.1%) involved hospitalization. The most common indication reported alongside adverse events was Migraine.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 84% were female and 16% male; age distribution skews toward 45-64, with 85 reports in that bracket. The single most reported reaction is drug hypersensitivity with 48 submissions, followed by drug ineffective and product dose omission issue.
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.