Drug Safety Information for EXFORGE HCT (Amlodipine; hydrochlorothiazide; valsartan)

Safety-related Labeling Changes for EXFORGE HCT (AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN) Rx Drug: FDA Link

Adverse Drug Reactions for EXFORGE HCT* (Amlodipine; hydrochlorothiazide; valsartan)

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 EXFORGE HCT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Blood pressure increased107
2Hypertension77
3Headache65
4Dizziness65
5Malaise65
6Oedema peripheral65
7Death61
8Wrong technique in drug usage process52
9Blood pressure decreased*50
10Fatigue*42
11Cerebrovascular accident40
12Dyspnoea38
13Hypotension37
14Feeling abnormal37
15Fall36
16Pain*35
17Infarction35
18Blood pressure inadequately controlled32
19Drug ineffective32
20Nausea31

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

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

Reason # of FDA Reports
1Hypertension2665
2Product used for unknown indication252
3Blood pressure68
4Blood pressure abnormal57
5Essential hypertension46
6Blood pressure increased32
7Cardiac disorder29
8Systolic hypertension18
9Aortic valve incompetence8
10Hypertonia6

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


Types of Adverse Events for EXFORGE HCT

Total Reports Filed with FDA: 4235


Number of FDA Adverse Event Reports by Patient Age for EXFORGE HCT

Total Reports Filed with FDA: 4235*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Amlodipine; hydrochlorothiazide; valsartan (Exforge hct)

Charts are based on 4235 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 EXFORGE HCT 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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