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What the label lists and what reports show

Butorphanol side effects

Butorphanol's FDA label: “The most frequently reported adverse experiences across all clinical trials with Butorphanol Tartrate Injection and Nasal Spray were somnolence (43%), dizziness (19%), nausea and/or vomiting (13%).” FAERS holds 326 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 (48 reports).

  • Generic listed
  • Boxed warning
  • DEA Schedule IV

Check it at the source: the butorphanol FDA label on DailyMed (effective January 2, 2026, Hospira, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most frequently reported adverse experiences across all clinical trials with Butorphanol Tartrate Injection and Nasal Spray were somnolence (43%), dizziness (19%), nausea and/or vomiting (13%).

From the label: adverse reactions, continued

Clinical Trial Experience A total of 1658 patients were studied in premarketing clinical trials of Butorphanol Tartrate Injection. In nearly all cases the type and incidence of side effects with butorphanol were those commonly observed with opioid analgesics. The adverse experiences described below are based on data from short- and long-term clinical trials in patients receiving Butorphanol Tartrate Injection. The most frequently reported adverse experiences across all clinical trials with Butorphanol Tartrate Injection and Nasal Spray were somnolence (43%), dizziness (19%), nausea and/or vomiting (13%).

Source: FDA drug label, Hospira, Inc., effective January 2, 2026 (SPL set 9822ca3f-aee2-46e5-8a96-495400e65d10), via openFDA; the full label on DailyMed

What do FAERS reports show?

326 reports list butorphanol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 9 are coded as a death and 50 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 21 reactions below, 11 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 Hypersensitivity48
  • Drug Ineffective (a use or a product term, not a reaction)45
  • Product Dose Omission Issue (a use or a product term, not a reaction)38
  • Nausea (named in the label)25
  • Headache (named in the label)17
  • Pruritus (named in the label)17
  • Pain (a use or a product term, not a reaction)16
  • Vomiting (named in the label)16
  • Anxiety (named in the label)14
  • Dyspnoea (named in the label)14
  • Migraine14
  • Product Quality Issue (a use or a product term, not a reaction)14
  • Dizziness (named in the label)12
  • Product Packaging Quantity Issue12
  • Depression10
  • Pneumonia10
  • Fatigue (named in the label)9
  • Malaise9
  • Product Taste Abnormal9
  • Blood Pressure Increased7
  • Insomnia (named in the label)7
  • Muscular Weakness7
  • Rash (named in the label)7
  • Somnolence (named in the label)7
  • Agitation6

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

What next?

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