Drug Safety Information for TWYNSTA (Amlodipine besylate; telmisartan)

Safety-related Labeling Changes for TWYNSTA (AMLODIPINE BESYLATE; TELMISARTAN) Rx Drug: FDA Link

Adverse Drug Reactions for TWYNSTA* (Amlodipine besylate; telmisartan)

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 TWYNSTA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Headache	11
2	Dizziness	11
3	Fatigue	9
4	Asthenia	8
5	Blood pressure increased	8
6	Rash	8
7	Hypertension	7
8	Hypotension	7
9	Pyrexia	6
10	Nausea	6
11	Chills	6
12	Insomnia	6
13	Chest pain	6
14	Hyponatraemia	5
15	Dyspnoea	5
16	Palpitations	5
17	Drug ineffective	5
18	Vomiting	5
19	General physical health deterioration	5
20	Tremor	5

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

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

	Reason	# of FDA Reports
1	Hypertension	302
2	Product used for unknown indication	33
3	Blood pressure increased	14
4	Blood pressure abnormal	4
5	Essential hypertension	4
6	Hypertonia	2
7	Blood pressure	1

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

Types of Adverse Events for TWYNSTA

Total Reports Filed with FDA: 557

Number of FDA Adverse Event Reports by Patient Age for TWYNSTA

Total Reports Filed with FDA: 557*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Amlodipine besylate; telmisartan (Twynsta)

Charts are based on 557 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.

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.