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What the label lists and what reports show

Levorphanol side effects

Levorphanol's FDA label lists its adverse reactions in its own words. FAERS holds 367 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 nausea (25 reports).

  • Generic listed
  • Boxed warning
  • DEA Schedule II

Check it at the source: the levorphanol FDA label on DailyMed (effective January 13, 2026, Sun Pharmaceutical Industries, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

In approximately 1400 patients treated with levorphanol tartrate tablets in controlled clinical trials, the type and incidence of side effects were those expected of an opioid analgesic, and no unforeseen or unusual toxicity was reported. Drugs of this type are expected to produce a cluster of typical opioid effects in addition to analgesia, consisting of nausea, vomiting, altered mood and mentation, pruritus, flushing, difficulties in urination, constipation, and biliary spasm. The frequency and intensity of these effects appears to be dose related. Although listed as adverse events these are expected pharmacologic actions of these drugs and should be interpreted as such by the clinician.

Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective January 13, 2026 (SPL set 438cf3ea-04fe-4626-9f0f-adcda7633651), via openFDA; the full label on DailyMed

What do FAERS reports show?

367 reports list levorphanol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 20 are coded as a death and 31 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 20 reactions below, 7 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

  • Product Dose Omission Issue (a use or a product term, not a reaction)36
  • Pain (a use or a product term, not a reaction)29
  • Drug Ineffective (a use or a product term, not a reaction)25
  • Nausea (named in the label)25
  • Product Dose Omission (a use or a product term, not a reaction)21
  • Headache (named in the label)17
  • Diarrhoea13
  • Hyperhidrosis13
  • Product Availability Issue12
  • Withdrawal Syndrome12
  • Anxiety11
  • Dizziness (named in the label)11
  • Inappropriate Schedule Of Drug Administration (a use or a product term, not a reaction)11
  • Vomiting (named in the label)11
  • Constipation (named in the label)9
  • Drug Dependence9
  • Dyspnoea9
  • Feeling Abnormal9
  • Malaise9
  • Pruritus (named in the label)9
  • Asthenia8
  • Insomnia8
  • Fall7
  • Hallucination7
  • Rash (named in the label)7

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

What next?

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