Drug Safety Information for ACCURETIC (Hydrochlorothiazide; quinapril hydrochloride)

Safety-related Labeling Changes for ACCURETIC (HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ACCURETIC* (Hydrochlorothiazide; 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 ACCURETIC
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Drug ineffective*34
2Nausea33
3Dyspnoea32
4Hypertension30
5Pain29
6Headache27
7Pain in extremity26
8Blood glucose increased26
9Weight decreased24
10Chest pain24
11Back pain22
12Dizziness22
13Diarrhoea21
14Vomiting20
15Blood pressure increased19
16Fatigue19
17Insomnia19
18Cough*19
19Syncope19
20Malaise19

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

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

Reason # of FDA Reports
1Hypertension692
2Product used for unknown indication214
3Blood pressure94
4Blood pressure abnormal41
5Atrial fibrillation11
6Blood pressure increased11
7Fluid retention11
8Cardiac disorder10
9Blood pressure management8
10Unevaluable event7

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


Types of Adverse Events for ACCURETIC

Total Reports Filed with FDA: 2708


Number of FDA Adverse Event Reports by Patient Age for ACCURETIC

Total Reports Filed with FDA: 2708*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Hydrochlorothiazide; quinapril hydrochloride (Quinaretic, Accuretic)

Charts are based on 2708 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 ACCURETIC 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.