Drug Safety Information for ACCUPRIL (Quinapril hydrochloride)

FDA Safety-related Labeling Changes for ACCUPRIL (QUINAPRIL HYDROCHLORIDE) Rx Drug: Safety Information Link

Adverse Drug Reactions for ACCUPRIL* (Quinapril hydrochloride)

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 ACCUPRIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea*541
2Myocardial infarction532
3Dyspnoea*509
4Dizziness471
5Drug ineffective437
6Pain421
7Cardiac failure congestive401
8Fatigue*392
9Diarrhoea387
10Hypertension386
11Cerebrovascular accident*361
12Asthenia352
13Headache346
14Chest pain334
15Oedema peripheral310
16Anxiety306
17Blood glucose increased301
18Vomiting294
19Fall284
20Pain in extremity282

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

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

Reason # of FDA Reports
1Hypertension*7461
2Product used for unknown indication2176
3Blood pressure978
4Ill-defined disorder492
5Blood pressure abnormal354
6Cardiac disorder220
7Blood pressure increased97
8Renal disorder67
9Essential hypertension64
10Cardiac failure congestive58

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


Types of Adverse Events for ACCUPRIL

Total Reports Filed with FDA: 45435


Number of FDA Adverse Event Reports by Patient Age for ACCUPRIL

Total Reports Filed with FDA: 45435*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Quinapril hydrochloride (Accupro, Accupril)

Charts are based on 45435 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 ACCUPRIL 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.