Drug Safety Information for VALTURNA (Aliskiren hemifumarate; valsartan)

Adverse Drug Reactions for VALTURNA* (Aliskiren hemifumarate; 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 VALTURNA
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Cerebrovascular accident	48
2	Blood pressure increased	45
3	Hypertension	41
4	Dizziness	36
5	Renal failure	25
6	Oedema peripheral	23
7	Hypotension	21
8	Renal disorder	20
9	Diarrhoea	19
10	Headache	18
11	Feeling abnormal	17
12	Drug ineffective	17
13	Dyspnoea	17
14	Malaise	16
15	Diabetes mellitus	16
16	Pruritus	16
17	Blood pressure fluctuation	15
18	Renal failure chronic	15
19	Blood pressure decreased	14
20	Fall	13

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

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

	Reason	# of FDA Reports
1	Hypertension*	363
2	Product used for unknown indication	131
3	Blood pressure	36
4	Blood pressure abnormal	31
5	Blood pressure increased	30
6	Oedema	25
7	Cardiac disorder	4
8	Depression	4
9	Hypoaesthesia	1

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

Types of Adverse Events for VALTURNA

Total Reports Filed with FDA: 1695

Number of FDA Adverse Event Reports by Patient Age for VALTURNA

Total Reports Filed with FDA: 1695*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Aliskiren hemifumarate; valsartan (Valturna)

Charts are based on 1695 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.