Drug Safety Information for TARKA (Trandolapril; verapamil hydrochloride)

Safety-related Labeling Changes for TARKA (TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for TARKA* (Trandolapril; verapamil 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 TARKA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
6Drug ineffective*54
10Renal failure acute43
12Blood pressure increased40
14Oedema peripheral37
15Cardiac failure congestive35
16Myocardial infarction34
17Cerebrovascular accident33
18Drug interaction33

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

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

Reason # of FDA Reports
2Product used for unknown indication554
3Essential hypertension129
4Heart rate increased121
5Blood pressure increased72
6Suicide attempt55
7Blood pressure abnormal39
8Blood pressure38
9Blood cholesterol increased16
10Blood pressure management13

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

Types of Adverse Events for TARKA

Total Reports Filed with FDA: 5209

Number of FDA Adverse Event Reports by Patient Age for TARKA

Total Reports Filed with FDA: 5209*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Trandolapril; verapamil hydrochloride (Tarka)

Charts are based on 5209 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 TARKA 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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