Drug Safety Information for ZESTRIL (Lisinopril)

Safety-related Labeling Changes for PRINIVIL (LISINOPRIL) Rx Drug: FDA Link

Safety-related Labeling Changes for ZESTRIL (LISINOPRIL) Rx Drug: FDA Link

Adverse Drug Reactions for ZESTRIL* (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 ZESTRIL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Nausea6509
2Dyspnoea5698
3Drug ineffective5450
4Dizziness*5208
5Fatigue*5047
6Diarrhoea4622
7Pain*4477
8Asthenia4084
9Headache*3917
10Vomiting3893
11Hypertension3300
12Myocardial infarction3280
13Cough*3139
14Hypotension3097
15Renal failure acute3062
16Fall3002
17Chest pain2939
18Flushing2886
19Angioedema2820
20Blood glucose increased2801

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

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

Reason # of FDA Reports
1Hypertension*86575
2Product used for unknown indication40183
3Blood pressure*10776
4Blood pressure abnormal4449
5Cardiac disorder1933
6Blood pressure increased*1915
7Cardiac failure congestive*1179
8Renal disorder837
9Essential hypertension764
10Prophylaxis732

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


Types of Adverse Events for ZESTRIL

Total Reports Filed with FDA: 472015


Number of FDA Adverse Event Reports by Patient Age for ZESTRIL

Total Reports Filed with FDA: 472015*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Lisinopril (Lisinopril 20mg, Lisinopril 5mg, Lisinopril, Lisinopril 40mg, Lisinopril 2.5mg, Lisinopril 10mg, Carace, Zestril, Prinivil)

Charts are based on 472015 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 ZESTRIL 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.