Pazopanib Hydrochloride side effects: what 26,904 FDA adverse event reports show

Pazopanib Hydrochloride · 1,061 reaction terms · 77,611 drug–reaction co-reports · data 2026-09-14

Drug class

Kinase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Who reports

26,904 reports · 67% serious · 6,943 with death outcome · 41% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Pazopanib tablets are a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy. ( 1.2 ) Limitations of Use: The efficacy of pazopanib tablets for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated.

FDA label, Indications and Usage

What it is

Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-Dimethyl-2 H -indazol-6-yl)methylamino]pyrimidin-2-yl]amino]-2-methylbenzenesulfonamide monohydrochloride. It has the molecular formula C 21 H 23 N 7 O 2 S·HCl and a molecular weight of 473.98 g/mol.

FDA label, Description section

Boxed warning

HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled adverse reaction 1Likely indication confounding 6Lab value / disease marker 2Not in label — unassessed 31

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,021 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Desmoplastic small round cell tumour	48	945.4 619.7–1,442.3ROR 947.1 · χ² 19,878 / p <1e-300	362.8 EB05 284.6 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious n=48 · ♀ 68% (drug 41%)	not reported in cached trials
Synovial sarcoma metastatic	11	650.0 291.2–1,450.7ROR 650.2 · χ² 3,517 / p <1e-300	219.0 EB05 130.5 · IC025 +3.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=11	not reported in cached trials
Malignant connective tissue neoplasm	10	640.1 276.6–1,481.4ROR 640.3 · χ² 3,140 / p <1e-300	210.0 EB05 121.9 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=9	not reported in cached trials
Soft tissue sarcoma	109	354.8 282.8–445.0ROR 356.2 · χ² 26,062 / p <1e-300	233.1 EB05 198.6 · IC025 +6.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=108	not reported in cached trials
Uterine leiomyosarcoma	17	207.3 121.3–354.1ROR 207.4 · χ² 2,588 / p <1e-300	138.4 EB05 91.5 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Leiomyosarcoma metastatic	14	199.1 110.6–358.4ROR 199.2 · χ² 2,037 / p <1e-300	130.6 EB05 82.7 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Osteosarcoma metastatic	16	155.6 90.9–266.2ROR 155.7 · χ² 1,917 / p <1e-300	112.5 EB05 73.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=15	not reported in cached trials
Neurofibrosarcoma	17	155.5 92.3–261.8ROR 155.6 · χ² 2,043 / p <1e-300	113.3 EB05 74.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Renal cell carcinoma stage iv	19	155.3 94.8–254.2ROR 155.4 · χ² 2,296 / p <1e-300	114.7 EB05 77.6 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious n=19	not reported in cached trials
Sarcoma metastatic	23	149.7 95.8–234.0ROR 149.8 · χ² 2,720 / p <1e-300	113.8 EB05 79.9 · IC025 +4.4 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=23	not reported in cached trials
Splenic necrosis	13	138.7 76.8–250.3ROR 138.8 · χ² 1,391 / p <1e-300	100.7 EB05 62.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Synovial sarcoma	14	132.8 75.3–234.1ROR 132.8 · χ² 1,451 / p <1e-300	98.5 EB05 62.4 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=14	not reported in cached trials
Angiosarcoma metastatic	17	125.6 75.2–209.6ROR 125.6 · χ² 1,700 / p <1e-300	96.6 EB05 63.9 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Polycystic liver disease	13	107.4 60.1–191.8ROR 107.4 · χ² 1,110 / p 9e-244	83.2 EB05 51.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Renal cancer metastatic	90	101.7 81.6–126.6ROR 102.0 · χ² 7,834 / p <1e-300	88.3 EB05 74.0 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious n=90	NCT00720941: 1/548 (0.2%) on Pazopanib (serious AE)
Renal cell carcinoma recurrent	11	82.8 44.5–154.3ROR 82.9 · χ² 731 / p 3e-161	66.6 EB05 39.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Renal cancer recurrent	14	81.5 47.0–141.3ROR 81.5 · χ² 935 / p 2e-205	67.3 EB05 42.6 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Metastatic renal cell carcinoma	175	81.2 69.5–94.8ROR 81.7 · χ² 12,462 / p <1e-300	72.9 EB05 64.3 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious n=172	not reported in cached trials
Angiosarcoma	41	75.3 54.7–103.8ROR 75.5 · χ² 2,672 / p <1e-300	66.7 EB05 51.2 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=41	not reported in cached trials
Eyelash discolouration	18	68.8 42.5–111.4ROR 68.8 · χ² 1,042 / p 6e-229	59.4 EB05 39.8 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=7	not reported in cached trials
Osteoma	13	60.2 34.2–105.8ROR 60.2 · χ² 647 / p 4e-143	51.9 EB05 32.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Metastases to soft tissue	18	57.6 35.7–93.0ROR 57.6 · χ² 879 / p 1e-193	50.9 EB05 34.1 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=18	not reported in cached trials
Hair colour changes	832	55.2 51.5–59.1ROR 56.9 · χ² 41,268 / p <1e-300	51.5 EB05 48.6 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=337	NCT01235962: 322/766 (42.0%) on Pazopanib; 9/204 (4.4%) control
Haemoglobin urine present	13	52.8 30.1–92.7ROR 52.9 · χ² 571 / p 2e-126	46.4 EB05 28.8 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious n=13	not reported in cached trials
Splenic cyst	13	50.9 29.1–89.3ROR 51.0 · χ² 551 / p 4e-122	44.9 EB05 27.9 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Rhabdomyosarcoma	11	48.0 26.1–88.3ROR 48.0 · χ² 433 / p 2e-96	42.2 EB05 25.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=11	not reported in cached trials
Leiomyosarcoma	22	47.1 30.6–72.4ROR 47.1 · χ² 892 / p 3e-196	42.9 EB05 29.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=22 · ♀ 67% (drug 41%)	not reported in cached trials
Activated partial thromboplastin time abnormal	14	47.0 27.4–80.5ROR 47.0 · χ² 551 / p 4e-122	42.0 EB05 26.6 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	serious n=14	not reported in cached trials
Renal cell carcinoma	277	46.3 41.1–52.3ROR 46.8 · χ² 11,548 / p <1e-300	43.6 EB05 39.5 · IC025 +5.1 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=274	not reported in cached trials
Metastases to pancreas	23	42.6 28.0–64.8ROR 42.6 · χ² 846 / p 3e-186	39.2 EB05 27.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=23 · ♀ 67% (drug 41%)	not reported in cached trials
Osteosarcoma	17	36.0 22.1–58.5ROR 36.0 · χ² 519 / p 3e-115	33.3 EB05 22.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=17	not reported in cached trials
Clear cell renal cell carcinoma	30	35.7 24.7–51.4ROR 35.7 · χ² 933 / p 3e-205	33.5 EB05 24.6 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=30 · ♀ 15% (drug 41%) · 100% clinician	not reported in cached trials
Liposarcoma	14	35.4 20.7–60.4ROR 35.4 · χ² 415 / p 2e-92	32.5 EB05 20.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious n=14	not reported in cached trials
Metastases to kidney	24	35.3 23.5–53.2ROR 35.3 · χ² 733 / p 1e-161	33.0 EB05 23.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=24	not reported in cached trials
Sarcoma	48	34.5 25.8–46.0ROR 34.5 · χ² 1,461 / p <1e-300	32.6 EB05 25.6 · IC025 +4.2 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious n=47	not reported in cached trials
Metastases to thorax	10	31.9 16.9–60.0ROR 31.9 · χ² 258 / p 2e-58	29.0 EB05 16.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=10	not reported in cached trials
Tumour pain	50	30.6 23.1–40.6ROR 30.6 · χ² 1,348 / p 3e-295	29.2 EB05 23.0 · IC025 +4.1 3/3 methods agree	Labeled adverse reaction exact term	serious n=43	not reported in cached trials
Lordosis	13	29.8 17.1–51.9ROR 29.8 · χ² 321 / p 4e-72	27.7 EB05 17.1 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Splenic lesion	13	28.5 16.4–49.6ROR 28.5 · χ² 307 / p 5e-69	26.5 EB05 16.4 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious n=13	not reported in cached trials
Metastases to adrenals	32	28.1 19.7–40.0ROR 28.1 · χ² 781 / p 4e-172	26.8 EB05 19.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious n=31	not reported in cached trials

Trial evidence (ClinicalTrials.gov)

✓ Trial adverse-event data found on ClinicalTrials.gov

Largest completed trials with posted results that list Pazopanib as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (2 of 40 signal terms matched).

NCT01235962 — A Study to Evaluate Pazopanib as an Adjuvant Treatment for Localized Renal Cell Carcinoma (RCC) (N=1538, PHASE3; 197 AE terms posted; arms: ITT Pazopanib 800 mg; ITT Placebo 800 mg; I TT Pazopanib 600 mg; ITT Placebo 600 mg)
NCT00720941 — Pazopanib Versus Sunitinib in the Treatment of Locally Advanced and/or Metastatic Renal Cell Carcinoma (N=1110, PHASE3; 369 AE terms posted; arms: Pazopanib 800 mg; Sunitinib 50 mg; Pazopanib 800 mg (Post-Treatment); Sunitinib 50 mg (Post-Treatment))

Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Death	4,579	4.2 4.1–4.3ROR 4.8 · χ² 11,401 / p <1e-300	4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree	Outcome field, not a reaction boxed warning mentions mortality	serious PRR 3.6	NCT00720941: 1/554 (0.2%) on Pazopanib (serious AE)
Diarrhoea (diarrhea)	3,606	4.4 4.3–4.5ROR 4.9 · χ² 9,676 / p <1e-300	4.4 EB05 4.2 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.0	NCT01235962: 4/766 (0.5%) on Pazopanib (serious AE)
Fatigue (tiredness)	2,490	2.5 2.4–2.6ROR 2.7 · χ² 2,325 / p <1e-300	2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.9	NCT01235962: 296/766 (38.6%) on Pazopanib; 53/204 (26.0%) control
Nausea	2,419	2.4 2.3–2.5ROR 2.5 · χ² 2,033 / p <1e-300	2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.9	NCT01235962: 315/766 (41.1%) on Pazopanib; 28/204 (13.7%) control
Malignant neoplasm progression	1,671	13.0 12.4–13.6ROR 13.8 · χ² 18,253 / p <1e-300	12.8 EB05 12.3 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 11.2	not reported in cached trials
Drug ineffective (drug did not work)	1,487	0.9 0.8–0.9ROR 0.9 · χ² 26 / p 2e-7	0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	serious PRR 1.0	not reported in cached trials
Decreased appetite (loss of appetite)	1,438	4.9 4.6–5.1ROR 5.1 · χ² 4,431 / p <1e-300	4.8 EB05 4.6 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.8	NCT01235962: 154/766 (20.1%) on Pazopanib; 11/204 (5.4%) control
Vomiting	1,406	2.3 2.2–2.5ROR 2.4 · χ² 1,101 / p 1e-241	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.8	NCT01235962: 1/766 (0.1%) on Pazopanib; 1/204 (0.5%) control (serious AE)
Hypertension (high blood pressure)	1,263	4.7 4.4–4.9ROR 4.8 · χ² 3,648 / p <1e-300	4.6 EB05 4.4 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.4	NCT01235962: 3/766 (0.4%) on Pazopanib; 1/558 (0.2%) control (serious AE)
Disease progression	1,013	6.7 6.3–7.2ROR 7.0 · χ² 4,936 / p <1e-300	6.7 EB05 6.3 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious PRR 4.7	NCT00720941: 1/554 (0.2%) on Pazopanib (serious AE)
Asthenia (weakness)	932	1.9 1.8–2.1ROR 2.0 · χ² 426 / p 6e-95	1.9 EB05 1.8 · IC025 +0.8	Labeled adverse reaction exact term	serious PRR 1.7	NCT01235962: 103/766 (13.4%) on Pazopanib; 12/204 (5.9%) control
Malaise (feeling unwell)	903	1.6 1.5–1.7ROR 1.6 · χ² 208 / p 2e-47	1.6 EB05 1.5 · IC025 +0.6	Not in label — unassessed	serious PRR 1.6	NCT00720941: 1/548 (0.2%) on Pazopanib (serious AE)
Weight decreased (weight loss)	882	2.5 2.3–2.6ROR 2.5 · χ² 777 / p 3e-171	2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 1.7	NCT01235962: 43/766 (5.6%) on Pazopanib; 2/204 (1.0%) control
Dyspnoea (shortness of breath)	845	1.2 1.1–1.2ROR 1.2 · χ² 20 / p 4e-6	1.2 EB05 1.1 · IC025 +0.1	Labeled adverse reaction exact term	serious PRR 1.2	NCT01235962: 2/766 (0.3%) on Pazopanib (serious AE)
Hair colour changes	832	55.2 51.5–59.1ROR 56.9 · χ² 41,268 / p <1e-300	51.5 EB05 48.6 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious n=337	NCT01235962: 322/766 (42.0%) on Pazopanib; 9/204 (4.4%) control

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Desmoplastic small round cell tumour — n=48, PRR 945.4
Renal cancer metastatic — n=90, PRR 101.7 (also seen in trial arm)
Metastatic renal cell carcinoma — n=175, PRR 81.2
Angiosarcoma — n=41, PRR 75.3
Hair colour changes — n=832, PRR 55.2 (also seen in trial arm)
Leiomyosarcoma — n=22, PRR 47.1
Metastases to pancreas — n=23, PRR 42.6
Clear cell renal cell carcinoma — n=30, PRR 35.7
Metastases to kidney — n=24, PRR 35.3
Metastases to adrenals — n=32, PRR 28.1

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Pazopanib?

In FDA FAERS, the most frequently co-reported reaction terms for Pazopanib are diarrhoea, fatigue, nausea, decreased appetite, vomiting, hypertension. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Pazopanib have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning.

Do FAERS signals prove that Pazopanib causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 115eb5bb-1403-fb3d-e063-6394a90ad320, effective 20251124; matched on openfda.generic_name.exact:"PAZOPANIB")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 1,061 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath
ClinicalTrials.gov API v2 (query PAZOPANIB, results-bearing studies sorted by enrollment)

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.