FDA Adverse Events Reports (FAERS) Summary for VOTRIENT

These tables and charts are based on 22,508 total reports for VOTRIENT (PAZOPANIB HYDROCHLORIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through April 28, 2026.

This FAERS total includes 20,582 pharmaceutical company-submitted and non-U.S. FAERS reports and 1,926 U.S. consumer or healthcare provider-submitted MedWatch reports. For a separate summary of the 1,926 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch VOTRIENT summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with VOTRIENT (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	DEATH	4270
2	DIARRHEA	3306
3	FATIGUE	2225
4	NAUSEA	2210
5	DECREASED APPETITE	1278
6	VOMITING	1231
7	DRUG INEFFECTIVE	1208
8	CANCER PROGRESSION	1146
9	HIGH BLOOD PRESSURE	1113
10	MALAISE	833
11	WEIGHT DECREASED	814
12	LACK OF STRENGTH AND ENERGY (ASTHENIA)	803
13	HAIR COLOUR CHANGES	783
14	DISEASE PROGRESSION	759
15	BLOOD PRESSURE INCREASED	740
16	SHORTNESS OF BREATH	679
17	HEADACHE	640
18	PAIN	606
19	METALLIC OR ALTERED TASTE	480
20	ABDOMINAL PAIN UPPER	457
21	RASH	438
22	PRODUCT USE IN UNAPPROVED INDICATION	419
23	ABDOMINAL PAIN	413
24	ABDOMINAL DISCOMFORT	397
25	PAIN IN EXTREMITY	385
26	DIZZINESS	373
27	ELEVATED LIVER ENZYMES	346
28	CONSTIPATION	345
29	COUGH	334
30	FEVER	331
31	DEHYDRATION	306
32	BACK PAIN	300
33	STOMATITIS	293
34	JOINT PAIN	290
35	HAIR LOSS	284
36	PLATELET COUNT DECREASED	282
37	LUNG CANCER	272
38	PNEUMONIA	257
39	CANCER MALIGNANT	253
40	OFF LABEL USE	250
41	HAND-FOOT SYNDROME	250
42	ANEMIA	240
43	RENAL CELL CARCINOMA	235
44	ALT LIVER ENZYME INCREASED	231
45	GENERAL PHYSICAL HEALTH DETERIORATION	227
46	LOSS OF TASTE	222
47	HOSPITALIZATION	219
48	MUSCLE SPASMS	217
49	LIVER FUNCTION ABNORMAL	211
50	ASPARTATE AMINOTRANSFERASE INCREASED	208
51	ADVERSE DRUG REACTION	203
52	CHEST PAIN	203
53	KIDNEY CANCER	202
54	PLEURAL EFFUSION	198
55	GAIT DISTURBANCE	196
56	LIVER DISORDER	193
57	DRUG INTOLERANCE	192
58	NOSEBLEED	192
59	FEELING ABNORMAL	192
60	BLOOD BILIRUBIN INCREASED	190
61	HYPOTHYROIDISM	190
62	INDIGESTION	189
63	FALL	186
64	ITCHING	184
65	DRUG DOSE OMISSION	182
66	SKIN DISCOLOURATION	182
67	STROKE	179
68	HOSPICE CARE	174
69	MUSCLE PAIN	167
70	KIDNEY IMPAIRMENT	166
71	CANCER PROGRESSION	159
72	PROTEINURIA	158
73	JAUNDICE	157
74	SWELLING OF LIMBS	153
75	BLISTER	152
76	CONFUSIONAL STATE	150
77	INSOMNIA	150
78	THROMBOCYTOPENIA	150
79	THERAPY CESSATION	147
80	METASTATIC RENAL CELL CARCINOMA	146
81	LIVER FUNCTION TEST ABNORMAL	144
82	PRODUCT USE ISSUE	143
83	BLOOD CREATININE INCREASED	142
84	HOARSE VOICE	142
85	LOWER LIMBS SWELLING	142
86	ABDOMINAL DISTENSION	141
87	SKIN REDNESS	140
88	HEART ATTACK (MYOCARDIAL INFARCTION)	140
89	COLLAPSE OF LUNG	137
90	LIVER DAMAGE	133
91	DRY SKIN	132
92	ORAL PAIN	132
93	METASTASES TO CENTRAL NERVOUS SYSTEM	131
94	HEART FAILURE	128
95	KIDNEY FAILURE	125
96	DIFFICULTY SWALLOWING	123
97	FLATULENCE	123
98	ILL-DEFINED DISORDER	122
99	COMMON COLD	122
100	BLEEDING	120

Latest Known Outcomes for Reactions Reported for VOTRIENT

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	12139
2	Patient died	5428
3	Patient has not recovered/symtoms have not resolved	3170
4	Patient recovered	2852
5	Patient is recovering/symptoms resolving	1955
6	Patient has recovered but has consequent health issues	138

Search all MedWatch and FAERS by keyword:

VOTRIENT Total Reports

Male	Female	Unknown	Total
12050	8226	2232	22,508

Top Countries Reporting

	Country	Number of Reports
1	United States	15347
2	Japan	1309
3	India	609
4	France	503
5	Canada	495
6	Colombia	401
7	Germany	361
8	Brazil	252
9	China	177
10	United Kingdom	154

Outcomes for Reports

Serious: 13720
Not Serious: 8788
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Product used for unknown indication
Malignant connective tissue neoplasm
KIDNEY CANCER
Renal cell carcinoma
CANCER MALIGNANT

Top Companies Reporting

NOVARTIS

Safety-Related FDA Updates

FDA Approval Date: 2009-10-19

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

Have experience (good or bad) with VOTRIENT? Rate VOTRIENT at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

This report, created by AskaPatient.com, is derived from the cases for VOTRIENT reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through April 28, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.