Pazopanib side effects: what 4,418 FDA adverse event reports show
Who reports
4,418 reports · 97% serious · 929 with death outcome · 45% female
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.
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.
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.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- 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. 121 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Metastases to lung | 100 | 41.5 34.1–50.4ROR 42.4 · χ² 3,877 / p <1e-300 | 40.8 EB05 34.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.7 | no trial data cached |
| Thyroid cancer | 85 | 33.5 27.1–41.4ROR 34.2 · χ² 2,633 / p <1e-300 | 33.1 EB05 27.6 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.9 · 100% clinician | no trial data cached |
| Malignant neoplasm progression | 513 | 24.0 22.1–26.1ROR 27.0 · χ² 11,292 / p <1e-300 | 23.9 EB05 22.2 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 14.4 · 93% clinician | no trial data cached |
| Hair colour changes | 59 | 22.4 17.3–28.8ROR 22.7 · χ² 1,178 / p 2e-258 | 22.1 EB05 17.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 22% (drug 45%) | no trial data cached |
| Pneumothorax | 63 | 18.9 14.8–24.2ROR 19.2 · χ² 1,049 / p 2e-230 | 18.8 EB05 15.2 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.1 · 97% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 36 | 18.0 13.0–25.0ROR 18.2 · χ² 560 / p 5e-124 | 17.8 EB05 13.3 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 · ♀ 90% (drug 45%) · 100% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 75 | 16.1 12.9–20.2ROR 16.4 · χ² 1,045 / p 1e-229 | 16.0 EB05 13.1 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.2 · 92% clinician | no trial data cached |
| Metastases to liver | 57 | 15.5 12.0–20.0ROR 15.7 · χ² 755 / p 1e-166 | 15.3 EB05 12.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 · 95% clinician | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 75 | 15.3 12.2–19.1ROR 15.5 · χ² 983 / p 4e-216 | 15.1 EB05 12.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 | no trial data cached |
| Proteinuria | 56 | 14.1 10.9–18.3ROR 14.3 · χ² 669 / p 8e-148 | 13.9 EB05 11.1 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 | no trial data cached |
| Metastases to central nervous system | 37 | 13.7 10.0–19.0ROR 13.9 · χ² 424 / p 2e-94 | 13.4 EB05 10.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 92% clinician | no trial data cached |
| Metastases to bone | 47 | 13.7 10.3–18.2ROR 13.8 · χ² 538 / p 2e-119 | 13.4 EB05 10.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 21% (drug 45%) | no trial data cached |
| Blood bilirubin increased | 70 | 12.3 9.7–15.5ROR 12.5 · χ² 714 / p 1e-157 | 12.1 EB05 9.8 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.4 | no trial data cached |
| Neoplasm progression | 82 | 11.1 9.0–13.8ROR 11.3 · χ² 744 / p 4e-164 | 10.9 EB05 9.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 98% clinician | no trial data cached |
| Alanine aminotransferase increased | 136 | 10.5 8.9–12.4ROR 10.8 · χ² 1,164 / p 2e-255 | 10.4 EB05 9.0 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 | no trial data cached |
| Hepatic function abnormal | 82 | 10.5 8.5–13.0ROR 10.7 · χ² 697 / p 8e-154 | 10.3 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 | no trial data cached |
| Ascites | 65 | 10.5 8.3–13.4ROR 10.7 · χ² 549 / p 9e-122 | 10.2 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 91% clinician | no trial data cached |
| Disease progression | 257 | 10.4 9.2–11.7ROR 10.9 · χ² 2,172 / p <1e-300 | 10.3 EB05 9.3 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 · 92% clinician | no trial data cached |
| Hypothyroidism | 68 | 10.2 8.0–12.9ROR 10.3 · χ² 552 / p 3e-122 | 9.9 EB05 8.0 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Transaminases increased | 46 | 9.8 7.4–13.1ROR 9.9 · χ² 356 / p 9e-80 | 9.4 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 93% clinician | no trial data cached |
| Therapy partial responder | 31 | 9.8 6.9–13.9ROR 9.8 · χ² 236 / p 2e-53 | 9.1 EB05 6.5 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 · 100% clinician | no trial data cached |
| Haematotoxicity | 19 | 9.7 6.2–15.3ROR 9.8 · χ² 140 / p 1e-32 | 8.6 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Hyperbilirubinaemia | 21 | 9.7 6.3–14.9ROR 9.7 · χ² 155 / p 8e-36 | 8.7 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 100% clinician | no trial data cached |
| Mucosal inflammation | 52 | 9.5 7.2–12.4ROR 9.6 · χ² 386 / p 3e-86 | 9.1 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 | no trial data cached |
| Hypertensive crisis | 21 | 8.9 5.8–13.7ROR 9.0 · χ² 140 / p 1e-32 | 7.9 EB05 5.3 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 · ♀ 80% (drug 45%) · 100% clinician | no trial data cached |
| Blood thyroid stimulating hormone increased | 17 | 8.8 5.4–14.1ROR 8.8 · χ² 109 / p 8e-26 | 7.5 EB05 4.8 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Aspartate aminotransferase increased | 86 | 7.7 6.2–9.5ROR 7.8 · χ² 495 / p 6e-110 | 7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 | no trial data cached |
| Ejection fraction decreased | 25 | 7.6 5.2–11.3ROR 7.7 · χ² 137 / p 5e-32 | 6.9 EB05 4.8 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.0 · 92% clinician | no trial data cached |
| Intestinal perforation | 18 | 7.6 4.8–12.1ROR 7.6 · χ² 97 / p 4e-23 | 6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.5 | no trial data cached |
| Blood alkaline phosphatase increased | 39 | 7.5 5.4–10.2ROR 7.5 · χ² 211 / p 4e-48 | 6.9 EB05 5.3 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.0 · 92% clinician | no trial data cached |
| Gamma-glutamyltransferase increased | 34 | 7.3 5.2–10.2ROR 7.3 · χ² 178 / p 7e-41 | 6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 4.2 · 97% clinician | no trial data cached |
| Jaundice (yellowing of skin/eyes) | 40 | 7.0 5.2–9.6ROR 7.1 · χ² 201 / p 5e-46 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 95% clinician | no trial data cached |
| Ileus | 18 | 7.0 4.4–11.0ROR 7.0 · χ² 86 / p 1e-20 | 6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Cardiomyopathy | 21 | 6.7 4.4–10.3ROR 6.8 · χ² 97 / p 3e-23 | 6.0 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · 100% clinician | no trial data cached |
| Pulmonary mass | 21 | 6.7 4.4–10.3ROR 6.7 · χ² 96 / p 5e-23 | 5.9 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Product use in unapproved indication | 343 | 6.7 6.0–7.4ROR 7.1 · χ² 1,665 / p <1e-300 | 6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · 99% clinician | no trial data cached |
| Hyperthyroidism | 20 | 6.6 4.2–10.2ROR 6.6 · χ² 89 / p 2e-21 | 5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 90% clinician | no trial data cached |
| Hypercalcaemia | 17 | 6.5 4.1–10.5ROR 6.6 · χ² 74 / p 3e-18 | 5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Pleural effusion | 78 | 6.1 4.9–7.6ROR 6.2 · χ² 327 / p 2e-73 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 95% clinician | no trial data cached |
| Drug-induced liver injury | 39 | 6.0 4.4–8.2ROR 6.1 · χ² 158 / p 2e-36 | 5.6 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 100% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 513 | 24.0 22.1–26.1ROR 27.0 · χ² 11,292 / p <1e-300 | 23.9 EB05 22.2 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 14.4 · 93% clinician | no trial data cached |
| Product use in unapproved indication | 343 | 6.7 6.0–7.4ROR 7.1 · χ² 1,665 / p <1e-300 | 6.6 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.4 · 99% clinician | no trial data cached |
| Death | 304 | 1.7 1.5–1.9ROR 1.7 · χ² 86 / p 1e-20 | 1.7 EB05 1.5 · IC025 +0.6 | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 1.0 | no trial data cached |
| Disease progression | 257 | 10.4 9.2–11.7ROR 10.9 · χ² 2,172 / p <1e-300 | 10.3 EB05 9.3 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 · 92% clinician | no trial data cached |
| Hypertension (high blood pressure) | 185 | 4.1 3.6–4.8ROR 4.3 · χ² 442 / p 2e-98 | 4.1 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Decreased appetite (loss of appetite) | 169 | 3.5 3.0–4.0ROR 3.6 · χ² 297 / p 7e-67 | 3.4 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Anaemia (low red blood cells) | 141 | 3.5 3.0–4.1ROR 3.6 · χ² 252 / p 4e-57 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 91% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 139 | 5.9 5.0–7.0ROR 6.1 · χ² 566 / p 2e-125 | 5.8 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.6 · 96% clinician | no trial data cached |
| Alanine aminotransferase increased | 136 | 10.5 8.9–12.4ROR 10.8 · χ² 1,164 / p 2e-255 | 10.4 EB05 9.0 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.1 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 113 | 4.0 3.3–4.8ROR 4.0 · χ² 249 / p 3e-56 | 3.9 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 · 95% clinician | no trial data cached |
| Metastases to lung | 100 | 41.5 34.1–50.4ROR 42.4 · χ² 3,877 / p <1e-300 | 40.8 EB05 34.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.7 | no trial data cached |
| Dehydration | 99 | 3.5 2.9–4.3ROR 3.6 · χ² 177 / p 9e-41 | 3.5 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 · 92% clinician | no trial data cached |
| Drug interaction | 97 | 2.9 2.4–3.5ROR 2.9 · χ² 120 / p 3e-28 | 2.9 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 1.9 · 95% clinician | no trial data cached |
| General physical health deterioration | 88 | 3.6 3.0–4.5ROR 3.7 · χ² 166 / p 2e-38 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 · 95% clinician | no trial data cached |
| Aspartate aminotransferase increased | 86 | 7.7 6.2–9.5ROR 7.8 · χ² 495 / p 6e-110 | 7.4 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 | no trial data cached |
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.
- Metastases to lung — n=100, PRR 41.5
- Hair colour changes — n=59, PRR 22.4
- Metastases to liver — n=57, PRR 15.5
- Palmar-plantar erythrodysaesthesia syndrome — n=75, PRR 15.3
- Metastases to central nervous system — n=37, PRR 13.7
- Metastases to bone — n=47, PRR 13.7
- Neoplasm progression — n=82, PRR 11.1
- Ascites — n=65, PRR 10.5
- Transaminases increased — n=46, PRR 9.8
- Hyperbilirubinaemia — n=21, PRR 9.7
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 hypertension, decreased appetite, anaemia, thrombocytopenia, alanine aminotransferase increased, neutropenia. 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, fieldpatient.drug.openfda.generic_name.exact, 161 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
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.