Chlorpromazine hydrochloride: adverse event reports filed with FDA

843

reports as suspect product

0% of all reports · about 38 a year

30

reports, 12 months to June 2026

65 in the 12 months before

91.9%

marked serious by the reporter

87.8% across the class

17.4%

record death among outcomes, as reported

147 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Chlorpromazine hydrochloride reports recording the termmedian drug in phenothiazine

1. Toxicity to various agentspoisoning or toxic effect of one or more substances10.8%91
2. Drug ineffectivethe medicine did not work as expected7.2%61
3. Overdosea dose above the recommended amount5.5%46
4. Neuroleptic malignant syndromea rare severe reaction with fever and rigidity4.4%37
5. Drug abusemisuse of a medicine4.2%35
6. Off label useused for a purpose or in a way not on the label4.2%35
7. Maternal exposure during pregnancythe mother took the medicine during pregnancy3.6%30
8. Foetal exposure during pregnancythe unborn baby was exposed to the medicine3.4%29
9. Myocarditisinflammation of the heart muscle2.7%23
10. Coma2.6%22
11. Completed suicidedeath by suicide2.6%22
12. Delusiona fixed false belief2.6%22
13. Drug interactionan interaction between medicines2.6%22
14. Foetal disorder2.6%22
15. Low birth weight baby2.6%22
16. Neutropenialow neutrophils, a type of white blood cell2.6%22
17. Premature babya baby born early2.6%22
18. Psychotic disordera loss of contact with reality2.6%22
19. Tachycardiafast heart rate2.6%22
20. Aggressionaggressive behaviour2.5%21
21. Headachehead pain2.3%19
22. Condition aggravatedthe condition being treated got worse2.1%18
23. Confusional stateconfusion2.1%18
24. Dizzinesslight-headedness or unsteadiness2.1%18
25. Hallucination, auditory2.1%18
26. Cardio-respiratory arrestthe heart and breathing stopped2%17
27. Fatiguetiredness2%17
28. Hypotensionlow blood pressure2%17
29. Malaisegeneral feeling of being unwell2%17
30. Product use in unapproved indicationused for a purpose not on the label2%17

Top 30 of 357 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 8 drugs in the phenothiazine class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 15,718 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 23.7% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 843 reports.

Drugs most often listed in the same reports

Other products listed in reports where Chlorpromazine hydrochloride is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the phenothiazine class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Chlorpromazine hydrochloride as a suspect or interacting product; reports listing it only as a concomitant medication (674) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.