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What the label lists and what reports show

Trifluoperazine side effects

Trifluoperazine's FDA label lists its adverse reactions in its own words. FAERS holds 122 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 euphoric mood (45 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the trifluoperazine FDA label on DailyMed (effective July 22, 2025, Mylan Institutional Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Drowsiness, dizziness, skin reactions, rash, dry mouth, insomnia, amenorrhea, fatigue, muscular weakness, anorexia, lactation, blurred vision and neuromuscular (extrapyramidal) reactions. Neuromuscular (Extrapyramidal) Reactions These symptoms are seen in a significant number of hospitalized mental patients. They may be characterized by motor restlessness, be of the dystonic type, or they may resemble parkinsonism. Depending on the severity of symptoms, dosage should be reduced or discontinued. If therapy is reinstituted, it should be at a lower dosage. Should these symptoms occur in children or pregnant patients, the drug should be stopped and not reinstituted. In most cases, barbiturates by suitable route of administration will suffice. …

Source: FDA drug label, Mylan Institutional Inc., effective July 22, 2025 (SPL set f742a579-411a-4140-91c4-edc735d638fa), via openFDA; the full label on DailyMed

What do FAERS reports show?

122 reports list trifluoperazine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 75 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 19 reactions below, 4 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 Ineffective (a use or a product term, not a reaction)46
  • Euphoric Mood45
  • Suicide Attempt45
  • Toxicity To Various Agents45
  • Weight Increased43
  • Akathisia (named in the label)41
  • Leukopenia (named in the label)41
  • Antipsychotic Drug Level Below Therapeutic40
  • Disinhibition40
  • Increased Appetite (named in the label)40
  • Obsessive-Compulsive Disorder40
  • Hypertension39
  • Therapeutic Product Effect Incomplete (a use or a product term, not a reaction)39
  • Therapeutic Product Effect Variable (a use or a product term, not a reaction)39
  • Dyslipidaemia38
  • Irritability38
  • Obesity38
  • Prescribed Overdose (a use or a product term, not a reaction)37
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)28
  • Off Label Use (a use or a product term, not a reaction)27
  • Schizoaffective Disorder26
  • Leukaemia19
  • Loss Of Consciousness18
  • Drug Abuse15
  • Insomnia (named in the label)12

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

What next?

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