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Nalbuphine Side Effects

The most commonly reported side effects of nalbuphine include dependence, overdose, and drug hypersensitivity, based on 1,897 FDA adverse event reports from 2004 to 2025. 2.8% of reports found the drug to be ineffective.

Nalbuphine side effects

Percentages show how often each reaction appears relative to total reports for nalbuphine.

1
Dependence16.8%318
2
Overdose10.3%195
3
Drug Hypersensitivity8.2%156
4
Off Label Use3.8%72
5
Death3.7%70
6
Drug Ineffective2.8%53
7
Pain2.4%45
8
Pancreatitis Acute2.2%41
9
Febrile Bone Marrow Aplasia2.1%40
10
Pyrexia2.0%38
11
Anxiety2.0%38
12
Convulsion2.0%37
13
Vomiting2.0%37
14
Product Use In Unapproved Indication1.9%36
15
Nausea1.8%35

These are voluntary reports and do not establish that nalbuphine caused these reactions.

Report severity

87.0%Serious1,650 reports
40.7%Hospitalizations772 reports
9.5%Fatal181 reports

Seriousness is determined by the reporter, not by OpenClaim.

Nalbuphine drug interactions

Other drugs that appear in adverse event reports alongside nalbuphine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Acetaminophen22.8%433
2
Oxycodone19.7%374
3
Tramadol-hydrochloride16.4%312
4
Methotrexate15.6%295
5
Morphine-sulfate15.4%292
6
Pegaspargase14.3%272
7
Vincristine-sulfate14.0%266
8
Fentanyl13.3%252
9
Oxymorphone-hydrochloride12.1%229
10
Buprenorphine10.3%196
11
Hydrocodone10.1%192
12
Promethazine-hydrochloride10.0%190
13
Cytarabine9.9%188
14
Codeine9.3%176
15
Dexamethasone8.9%168

Taken alongside

1
Acetaminophen25.5%484
2
Ondansetron14.4%273
3
Sulfamethoxazole12.7%241
4
Hydroxyzine12.0%227
5
Trimethoprim11.4%216
6
Vancomycin10.8%204
7
Apomorphine-hydrochloride8.2%155
8
Omeprazole7.9%150
9
Furosemide6.5%124
10
Amphotericin-b6.5%123
11
Amoxicillin6.1%115
12
Pantoprazole-sodium6.0%113
13
Promethazine-hydrochloride5.5%105
14
Oxycodone5.5%105
15
Diphenhydramine5.5%105

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports nalbuphine side effects

51.8% of nalbuphine adverse event reports involve female patients and 38.9% involve male patients. The largest age group is adult at 41%. These figures reflect who reports side effects, not underlying risk.

Sex

Female51.8%
Male38.9%
Unknown9.3%

Age group

< 27.1%
2–1125.1%
12–1713.4%
18–6441.3%
65+13.0%

What is nalbuphine used for

Conditions and purposes for which patients were taking nalbuphine when the adverse event was reported.

Abdominal PainAbdominal Pain UpperAnaesthesiaAnalgesiaAnalgesic EffectAnalgesic Intervention Supportive TherapyAnalgesic TherapyArthralgiaArthritisAbdominal PainAcute Myeloid LeukaemiaAdverse Drug ReactionAnalgesic TherapyAnogenital WartsBack Pain

Showing 15 of 148 indications

Nalbuphine brand names and reporting trend

Nalbuphine is sold under the brand name Nubain.

Brand names

Nubain5

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking nalbuphine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.