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What the label lists and what reports show

Chlorpromazine side effects

Chlorpromazine's FDA label lists its adverse reactions in its own words. FAERS holds 7,098 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 toxicity to various agents (458 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the chlorpromazine FDA label on DailyMed (effective May 12, 2026, Amneal Pharmaceuticals NY LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Note: Some adverse effects of chlorpromazine may be more likely to occur, or occur with greater intensity, in patients with special medical problems, e.g., patients with mitral insufficiency or pheochromocytoma have experienced severe hypotension following recommended doses. Drowsiness: Usually mild to moderate, may occur, particularly during the first or second week, after which it generally disappears. If troublesome, dosage may be lowered. Jaundice: Overall incidence has been low, regardless of indication or dosage. Most investigators conclude it is a sensitivity reaction. Most cases occur between the second and fourth weeks of therapy. The clinical picture resembles infectious hepatitis, with laboratory features of obstructive jaundice, rather than those of parenchymal damage. It is usually promptly reversible on withdrawal of the medication; …

Source: FDA drug label, Amneal Pharmaceuticals NY LLC, effective May 12, 2026 (SPL set aa086a21-de85-4b03-af58-49b70acf8cf0), via openFDA; the full label on DailyMed

What do FAERS reports show?

7,098 reports list chlorpromazine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,324 are coded as a death and 3,306 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 15 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.

Reports received each year

The 25 most reported reactions

  • Drug Ineffective (a use or a product term, not a reaction)544
  • Toxicity To Various Agents458
  • Off Label Use (a use or a product term, not a reaction)449
  • Overdose (a use or a product term, not a reaction)354
  • Drug Interaction (a use or a product term, not a reaction)326
  • Neuroleptic Malignant Syndrome (named in the label)294
  • Nausea (a use or a product term, not a reaction)275
  • Neutropenia (named in the label)271
  • Diarrhoea256
  • Fatigue253
  • Vomiting (a use or a product term, not a reaction)251
  • Somnolence (named in the label)241
  • Psychotic Disorder (a use or a product term, not a reaction)229
  • Suicide Attempt222
  • Hypotension (named in the label)206
  • Condition Aggravated (a use or a product term, not a reaction)205
  • Death (an outcome recorded in the report)205
  • Seizure (named in the label)203
  • Completed Suicide (an outcome recorded in the report)198
  • Drug Abuse198
  • Aggression195
  • Insomnia (named in the label)192
  • Anxiety186
  • Agitation (named in the label)184
  • Confusional State183

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

What next?

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