Drug Safety Information for DIOVAN (Valsartan)
Recall for VALSARTAN (VALSARTAN) Rx Drug: FDA Link
NDMA contamination voluntary recalls of some products
Safety-related Labeling Changes for DIOVAN (VALSARTAN) Rx Drug: FDA Link
Adverse Drug Reactions for DIOVAN* (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 DIOVAN
(reported in FDA Medwatch/FAERS Reports)
Side Effect | # of FDA Reports | |
---|---|---|
1 | Dizziness* | 2697 |
2 | Nausea | 2559 |
3 | Dyspnoea | 2545 |
4 | Hypertension | 2267 |
5 | Drug ineffective | 2204 |
6 | Fatigue* | 2197 |
7 | Blood pressure increased | 2182 |
8 | Headache* | 2043 |
9 | Diarrhoea | 1873 |
10 | Asthenia | 1820 |
11 | Fall | 1811 |
12 | Pain* | 1771 |
13 | Malaise | 1722 |
14 | Vomiting | 1581 |
15 | Death | 1558 |
16 | Cerebrovascular accident | 1549 |
17 | Myocardial infarction | 1517 |
18 | Oedema peripheral | 1458 |
19 | Hypotension | 1345 |
20 | Pain in extremity | 1336 |
* This side effect also appears in "Top 10 Side Effects of DIOVAN " in the drug's Review Summary based on AskaPatient reviews.
Top 10 Reasons for Taking DIOVAN
(associated with FDA Medwatch/FAERS Reports)
Reason | # of FDA Reports | |
---|---|---|
1 | Hypertension* | 67120 |
2 | Product used for unknown indication | 15287 |
3 | Blood pressure* | 4258 |
4 | Blood pressure abnormal | 1569 |
5 | Cardiac disorder | 1112 |
6 | Blood pressure increased* | 1078 |
7 | Essential hypertension | 641 |
8 | Cardiovascular disorder | 547 |
9 | Cardiac failure | 408 |
10 | Cardiac failure chronic | 330 |
*Also a top-10 reason in AskaPatient Review Summary.
Types of Adverse Events for DIOVAN
Total Reports Filed with FDA: 228025
Number of FDA Adverse Event Reports by Patient Age for DIOVAN
Total Reports Filed with FDA: 228025*
* Reports for drugs with the same active ingredients have been aggregated in this analysis: Valsartan (Exforge 10/160, Vals, Cgp 48933, Nisis, Exforge 5/160, Tareg, Miten, Kalpress, Diovan hct 160/12.5, Provas, Valsartan, Diovan)
Charts are based on 228025 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 DIOVAN Reviews and Review Summary .
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.