Drug Safety Information for CAPTOPRIL (Captopril)

FDA Safety-related Labeling Changes for CAPOTEN (CAPTOPRIL) Discontinued Drug: Safety Information Link

Adverse Drug Reactions for CAPTOPRIL* (Captopril)

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 CAPTOPRIL
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Dyspnoea	443
2	Hypertension	342
3	Asthenia*	319
4	Pain*	316
5	Drug ineffective	312
6	Dizziness*	304
7	Nausea	288
8	Pneumonia	282
9	Vomiting	275
10	Myocardial infarction	273
11	Renal failure	258
12	Headache	258
13	Diarrhoea	258
14	Fatigue	243
15	Cardiac failure congestive	242
16	Pyrexia	237
17	Hypotension	227
18	Blood pressure increased	222
19	Oedema peripheral	216
20	Chest pain	216

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

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

	Reason	# of FDA Reports
1	Hypertension*	6485
2	Product used for unknown indication	2257
3	Blood pressure	632
4	Blood pressure increased	273
5	Cardiac disorder	260
6	Blood pressure abnormal	159
7	Cardiac failure congestive	132
8	Ill-defined disorder	123
9	Cardiac failure	114
10	Suicide attempt	105

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

Types of Adverse Events for CAPTOPRIL

Total Reports Filed with FDA: 37281

Number of FDA Adverse Event Reports by Patient Age for CAPTOPRIL

Total Reports Filed with FDA: 37281*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Captopril (Tensopril, Lopirin, Acepril, Capoten, Captopril)

Charts are based on 37281 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.

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.