Drug Safety Information for EDARBI (Azilsartan medoxomil)

Safety-related Labeling Changes for EDARBI (AZILSARTAN KAMEDOXOMIL) Rx Drug: FDA Link

Adverse Drug Reactions for EDARBI* (Azilsartan medoxomil)

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 EDARBI
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Dizziness	21
2	Nausea	13
3	Hypotension	12
4	Fatigue	12
5	Diarrhoea	12
6	Drug ineffective	11
7	Death	10
8	Anaemia	10
9	Feeling abnormal	9
10	Hypertension	9
11	Blood pressure increased	9
12	Asthenia	8
13	Loss of consciousness	8
14	Fall	8
15	Decreased appetite	7
16	Muscle spasms	7
17	Syncope	7
18	Cardiac failure	6
19	Vomiting	6
20	Blood creatinine increased	6

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

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

	Reason	# of FDA Reports
1	Hypertension	332
2	Product used for unknown indication	84
3	Essential hypertension	46
4	Blood pressure abnormal	30
5	Blood pressure	27
6	Blood pressure management	2

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

Types of Adverse Events for EDARBI

Total Reports Filed with FDA: 741

Number of FDA Adverse Event Reports by Patient Age for EDARBI

Total Reports Filed with FDA: 741*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Azilsartan medoxomil (Edarbi)

Charts are based on 741 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.