Prochlorperazine: adverse event reports filed with FDA

1,798

reports as suspect product

0% of all reports · about 81 a year

158

reports, 12 months to June 2026

239 in the 12 months before

85.5%

marked serious by the reporter

87.8% across the class

10.3%

record death among outcomes, as reported

186 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 Prochlorperazine reports recording the termmedian drug in phenothiazine

1. Nauseafeeling sick22.7%409
2. Vomitingbeing sick16.4%295
3. Fatiguetiredness13.2%237
4. Coughcough12.8%231
5. Drug ineffectivethe medicine did not work as expected12.3%222
6. Malaisegeneral feeling of being unwell11.6%208
7. Anxietyanxiety11.5%207
8. Headachehead pain11.3%204
9. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease11%198
10. Pyrexiafever11%197
11. Falla fall10.8%194
12. Confusional stateconfusion10.7%193
13. Gastrointestinal disorder10.5%189
14. Blood pressure increaseda raised blood pressure reading10.5%188
15. Muscle spasticity10.4%187
16. Chest discomfortchest discomfort10.3%186
17. Painpain, site not specified10.3%185
18. Pneumonialung infection10.2%184
19. Influenza like illnessflu-like symptoms10.1%182
20. Cataractclouding of the eye lens10.1%181
21. Arterial occlusive disease10%180
22. Dysphagiadifficulty swallowing10%180
23. Gangrenedeath of tissue10%180
24. Palpitationsawareness of the heartbeat10%180
25. Sinusitissinus infection10%180
26. Angina pectoris9.9%178
27. Sneezing9.9%178
28. Cerebrovascular accidentstroke9.7%174
29. Dysarthria9.7%174
30. Rhinorrhoeaa runny nose9.7%174

Top 30 of 543 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. 44.6% 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 1,798 reports.

Drugs most often listed in the same reports

Other products listed in reports where Prochlorperazine 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 Prochlorperazine as a suspect or interacting product; reports listing it only as a concomitant medication (26,184) 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.