Drug Safety Information for PROCHLORPERAZINE (Prochlorperazine maleate)

Adverse Drug Reactions for PROCHLORPERAZINE* (Prochlorperazine maleate)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with PROCHLORPERAZINE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea2246
2Vomiting1669
3Diarrhoea1489
4Fatigue1309
5Dehydration1194
6Dyspnoea1128
7Asthenia1015
8Pyrexia956
9Death867
10Anaemia858
11Pain*851
12Pneumonia823
13Decreased appetite747
14Abdominal pain727
15Dizziness724
16Neutropenia614
17Hypotension610
18Headache600
19Febrile neutropenia589
20Weight decreased574

* This side effect also appears in "Top 10 Side Effects of PROCHLORPERAZINE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking PROCHLORPERAZINE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Nausea*12133
2Product used for unknown indication8300
3Vomiting*601
4Prophylaxis of nausea and vomiting440
5Prophylaxis368
6Vertigo215
7Headache*146
8Migraine*144
9Dizziness141
10Antiemetic supportive care140

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for PROCHLORPERAZINE

Total Reports Filed with FDA: 103808


Number of FDA Adverse Event Reports by Patient Age for PROCHLORPERAZINE

Total Reports Filed with FDA: 103808*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Prochlorperazine maleate (Compro, Proclorperazina, Stemetil, Compazine, Prochlorperazine)

Charts are based on 103808 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and PROCHLORPERAZINE Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.