Drug Safety Information for VOTRIENT (Pazopanib hydrochloride)

Safety-related Labeling Changes for VOTRIENT (PAZOPANIB HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for VOTRIENT* (Pazopanib hydrochloride)

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 VOTRIENT
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea*1305
2Death1273
3Nausea1002
4Fatigue980
5Vomiting583
6Decreased appetite548
7Drug ineffective502
8Hypertension481
9Disease progression431
10Blood pressure increased344
11Asthenia323
12Weight decreased322
13Hair colour changes321
14Dyspnoea302
15Headache269
16Malaise260
17Neoplasm malignant255
18Dysgeusia232
19Abdominal pain218
20Pain207

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

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

Reason # of FDA Reports
1Renal cancer6063
2Renal cell carcinoma3970
3Product used for unknown indication3787
4Sarcoma1109
5Metastatic renal cell carcinoma1001
6Renal cancer metastatic762
7Neoplasm malignant749
8Malignant urinary tract neoplasm369
9Neoplasm361
10Leiomyosarcoma359

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


Types of Adverse Events for VOTRIENT

Total Reports Filed with FDA: 26689


Number of FDA Adverse Event Reports by Patient Age for VOTRIENT

Total Reports Filed with FDA: 26689*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pazopanib hydrochloride (Votrient)

Charts are based on 26689 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 VOTRIENT 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.