Drug Safety Information for ZESTORETIC (Hydrochlorothiazide; lisinopril)

Safety-related Labeling Changes for ZESTORETIC (HYDROCHLOROTHIAZIDE; LISINOPRIL) Rx Drug: FDA Link

Adverse Drug Reactions for ZESTORETIC* (Hydrochlorothiazide; lisinopril)

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 ZESTORETIC
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea436
2Dizziness*353
3Fatigue345
4Drug ineffective325
5Dyspnoea319
6Diarrhoea310
7Pain*295
8Headache*285
9Angioedema280
10Hypertension245
11Asthenia233
12Cough*232
13Vomiting218
14Renal failure acute211
15Arthralgia*207
16Hypotension194
17Fall194
18Flushing192
19Pruritus*185
20Malaise180

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

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

Reason # of FDA Reports
1Hypertension*6972
2Product used for unknown indication2325
3Blood pressure*766
4Blood pressure abnormal245
5Essential hypertension170
6Blood pressure increased169
7Cardiac disorder72
8Fluid retention70
9Oedema peripheral54
10Diuretic therapy27

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


Types of Adverse Events for ZESTORETIC

Total Reports Filed with FDA: 28541


Number of FDA Adverse Event Reports by Patient Age for ZESTORETIC

Total Reports Filed with FDA: 28541*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Hydrochlorothiazide; lisinopril (Prinzide, Zestoretic)

Charts are based on 28541 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 ZESTORETIC Reviews and Review Summary .

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.

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