nalbuphine Side Effects
Also known as: Nubain
Analysis of 218 adverse event reports submitted to the FDA from 2007 to 2025.
Total Reports
218
Death-Related
10
4.6% of reports
Hospitalizations
77
35.3% 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 10 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| ACUTE KIDNEY INJURY | 2 |
| CONTUSION | 2 |
| HYPERTENSION | 2 |
| HYPOTENSION | 2 |
| RENAL IMPAIRMENT | 2 |
| RESPIRATORY FAILURE | 2 |
| ANAEMIA | 1 |
| ANAPHYLACTOID REACTION | 1 |
| AREFLEXIA | 1 |
| B-CELL TYPE ACUTE LEUKAEMIA | 1 |
| BACK PAIN | 1 |
| BLINDNESS UNILATERAL | 1 |
| BLISTER | 1 |
| BRAIN MIDLINE SHIFT | 1 |
| BRAIN OEDEMA | 1 |
| CANDIDA SEPSIS | 1 |
| CAPILLARY LEAK SYNDROME | 1 |
| CARDIO-RESPIRATORY ARREST | 1 |
| CEREBRAL HAEMORRHAGE | 1 |
| CHRONIC KIDNEY DISEASE | 1 |
Reactions in Hospitalization Reports
Top reactions in 77 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| ACUTE HEPATIC FAILURE | 6 |
| DRUG INEFFECTIVE | 6 |
| PANCREATITIS ACUTE | 6 |
| FEBRILE BONE MARROW APLASIA | 4 |
| MENTAL STATUS CHANGES | 4 |
| PYREXIA | 4 |
| CARDIAC PERFUSION DEFECT | 3 |
| DRUG CLEARANCE DECREASED | 3 |
| FATIGUE | 3 |
| HAEMODYNAMIC INSTABILITY | 3 |
| INTRA-ABDOMINAL HAEMORRHAGE | 3 |
| OFF LABEL USE | 3 |
| RESPIRATORY FAILURE | 3 |
| ACUTE KIDNEY INJURY | 2 |
| AGRANULOCYTOSIS | 2 |
| AMNESIA | 2 |
| ANAEMIA | 2 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 2 |
| ASTHENIA | 2 |
| BRADYCARDIA | 2 |
Nearby — Related Medications
What the FAERS Data Reveals About nalbuphine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 218 voluntary reports linked to nalbuphine and its brand equivalents (Nubain), spanning 2007 through 2025. Of those, 10 (4.6%) listed death as an outcome and 77 (35.3%) 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, 69% were female and 31% male; age distribution skews toward 0-17, with 74 reports in that bracket. The single most reported reaction is drug hypersensitivity with 36 submissions, followed by off label use and drug ineffective.
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.