Drug Safety Information for VASOTEC (Enalapril maleate)

Safety-related Labeling Changes for VASOTEC (ENALAPRIL MALEATE) Rx Drug: FDA Link

Safety-related Labeling Changes for VASERETIC (ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE) Rx Drug: FDA Link

Safety-related Labeling Changes for EPANED KIT (ENALAPRIL MALEATE) Discontinued Drug: FDA Link

Adverse Drug Reactions for VASOTEC* (Enalapril maleate)

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 VASOTEC
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea1731
2Nausea1625
3Diarrhoea1385
4Dizziness*1378
5Fatigue*1287
6Vomiting1245
7Drug ineffective*1207
8Renal failure acute1185
9Myocardial infarction1177
10Pain1119
11Asthenia1107
12Drug interaction1070
13Hypertension1062
14Hypotension1058
15Headache1017
16Fall990
17Cardiac failure congestive975
18Renal failure915
19Pneumonia893
20Anaemia887

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

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

Reason # of FDA Reports
1Hypertension*28460
2Product used for unknown indication13322
3Blood pressure*2301
4Cardiac failure1690
5Blood pressure abnormal1022
6Cardiac disorder821
7Essential hypertension804
8Blood pressure increased719
9Cardiac failure chronic690
10Cardiac failure congestive531

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


Types of Adverse Events for VASOTEC

Total Reports Filed with FDA: 152338


Number of FDA Adverse Event Reports by Patient Age for VASOTEC

Total Reports Filed with FDA: 152338*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Enalapril maleate (Vasotec, Enalapril, Xanef, Enalaprilat)

Charts are based on 152338 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 VASOTEC 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.

Visit   DrugInformer.com more on VASOTEC's side effects.