LOW-VOLUME · SEX-BALANCED
nalbuphine Side Effects
nalbuphine (also sold as Nubain) is a LOW-VOLUME FAERS extract #515 of 524 by FAERS report count. Still opens on SEX-BALANCED: 69% of sex-coded reports are female (135 F / 62 M).
Data updated 2026-05-15
- 218
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
nalbuphine reporting skew - 69% of sex-coded reports are female (135 F / 62 M). Volume band LOW-VOLUME #515 of 524 by FAERS report count; caseload TRACE-CASE.
Thinner FAERS extract for nalbuphine (Nubain) (218 reports #515 of 524 by FAERS report count). 69% of sex-coded reports are female (135 F / 62 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (2007–2025). Stamps TRACE-CASE · DEATH-MARKED · HOSP-HEAVY · SEX-BALANCED.
DRUG HYPERSENSITIVITY leads 36 of 218 reports
Who reports · age peak 0-17 (SEX-BALANCED)
Sex coding · SEX-BALANCED
Age peak 0-17 (74 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death appears on 10 reports (4.6% - MARKED). Reactions below co-occur in those rows only.
| 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
Hospitalization is HEAVY (77, 35.3% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| ACUTE HEPATIC FAILURE | 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 |
| RESPIRATORY FAILURE | 3 |
| ACUTE KIDNEY INJURY | 2 |
| AGRANULOCYTOSIS | 2 |
| AMNESIA | 2 |
| ANAEMIA | 2 |
| ASPARTATE AMINOTRANSFERASE INCREASED | 2 |
| ASTHENIA | 2 |
| BRADYCARDIA | 2 |
How to read nalbuphine FAERS figures (TRACE-CASE · DEATH-MARKED · HOSP-HEAVY)
FAERS holds 218 voluntary reports linked to nalbuphine (Nubain), 2007-2025. Death is listed on 10 (4.6%). Hospitalization appears on 77 (35.3%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and SEX-BALANCED skew still differ by drug; not a complete safety profile.
Read with nalbuphine
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-MARKED · HOSP-HEAVY stamps.
ABS(total_reports) peer at 205 FAERS cases (Δ 13 lighter vs nalbuphine); DEATH-HEAVY · HOSP-MID · SEX-BALANCED vs this page's TRACE-CASE · DEATH-MARKED · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 178 FAERS cases (Δ 40 lighter vs nalbuphine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's TRACE-CASE · DEATH-MARKED · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 278 FAERS cases (Δ 60 heavier vs nalbuphine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's TRACE-CASE · DEATH-MARKED · HOSP-HEAVY · SEX-BALANCED.
ABS(total_reports) peer at 299 FAERS cases (Δ 81 heavier vs nalbuphine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's TRACE-CASE · DEATH-MARKED · HOSP-HEAVY · SEX-BALANCED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 57.5 pp vs nalbuphine's DEATH-MARKED): CASELOAD · HOSP-MID.
nalbuphine stamps DEATH-MARKED · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload TRACE-CASE and the label guide.