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What the label lists and what reports show

Nalbuphine side effects

Nalbuphine's FDA label lists its adverse reactions in its own words. FAERS holds 225 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug hypersensitivity (36 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the nalbuphine FDA label on DailyMed (effective December 31, 2025, Hospira, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most frequent adverse reaction in 1066 patients treated in clinical studies with Nalbuphine Hydrochloride Injection was sedation 381 (36%). Less frequent reactions were: sweaty/clammy 99 (9%), nausea/vomiting 68 (6%), dizziness/vertigo 58 (5%), dry mouth 44 (4%), and headache 27 (3%). Other adverse reactions which occurred (reported incidence of 1% or less) were: CNS Effects: Nervousness, depression, restlessness, crying, euphoria, floating, hostility, unusual dreams, confusion, faintness, hallucinations, dysphoria, feeling of heaviness, numbness, tingling, unreality. The incidence of psychotomimetic effects, such as unreality, depersonalization, delusions, dysphoria and hallucinations has been shown to be less than that which occurs with pentazocine. Cardiovascular: Hypertension, hypotension, bradycardia, tachycardia. Gastrointestinal: Cramps, dyspepsia, bitter taste. …

Source: FDA drug label, Hospira, Inc., effective December 31, 2025 (SPL set 6025e8d4-5083-4c3a-58a0-050e7b0b6150), via openFDA; the full label on DailyMed

What do FAERS reports show?

225 reports list nalbuphine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 79 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Drug Hypersensitivity36
  • Off Label Use (a use or a product term, not a reaction)16
  • Drug Ineffective (a use or a product term, not a reaction)11
  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)10
  • Neonatal Asphyxia10
  • Neonatal Epileptic Seizure10
  • Malaise7
  • Pain (a use or a product term, not a reaction)7
  • Pancreatitis Acute7
  • Vomiting (named in the label)7
  • Acute Hepatic Failure6
  • Encephalopathy6
  • Product Package Associated Injury6
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)6
  • Pruritus (named in the label)6
  • Pyrexia (named in the label)6
  • Drug Interaction (a use or a product term, not a reaction)5
  • Fatigue (named in the label)5
  • Headache (named in the label)5
  • Hypertension (named in the label)5
  • Hypotension (named in the label)5
  • Nausea (named in the label)5
  • Somnolence (named in the label)5
  • Urticaria (named in the label)5
  • Wrong Technique In Product Usage Process (a use or a product term, not a reaction)5

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Nalbuphine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions