Sunitinib Malate side effects: what 39,092 FDA adverse event reports show
Drug class
Kinase inhibitor
Who reports
39,092 reports · 77% serious · 11,666 with death outcome · 35% female
Used for
Sunitinib malate is a kinase inhibitor indicated for: treatment of adult patients with gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. ( 1.1 ) treatment of adult patients with advanced renal cell carcinoma (RCC). ( 1.2 ) adjuvant treatment of adult patients at high risk of recurrent RCC following nephrectomy.
What it is
Sunitinib is a kinase inhibitor present in sunitinib malate capsules as the malate salt. Sunitinib malate is described chemically as N-(2-(Diethylamino)ethyl)-5-((Z)-(5-fluoro-1,2-dihydro-2-oxo-3H-indol-3-ylidene)methyl)-2,4-dimethyl-1H-pyrrole-3-carboxamide (2S)-hydroxybutanedioate acid.
Boxed warning
HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate capsules 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 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.
- 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.
- 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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,100 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 |
|---|---|---|---|---|---|---|
| Metastatic renal cell carcinoma | 764 | 378.3 344.9–414.9ROR 385.8 · calibrated p 9e-13 ✓ | 219.7 EB05 206.9 · IC025 +7.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=639 | not reported in cached trials |
| Renal cancer metastatic | 196 | 180.4 153.5–212.1ROR 181.3 · calibrated p 1e-9 ✓ | 133.0 EB05 118.1 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=147 | not reported in cached trials |
| Renal cell carcinoma stage iv | 26 | 157.9 101.9–244.7ROR 158.0 · calibrated p 1e-8 ✓ | 112.0 EB05 80.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=22 | not reported in cached trials |
| Renal cell carcinoma | 975 | 132.3 123.4–141.8ROR 135.7 · calibrated p 1e-8 ✓ | 105.8 EB05 100.3 · IC025 +6.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=785 | not reported in cached trials |
| Gastrointestinal stromal tumour | 436 | 104.3 94.2–115.6ROR 105.5 · calibrated p 8e-8 ✓ | 87.0 EB05 80.3 · IC025 +6.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=381 | not reported in cached trials |
| Yellow skin | 680 | 91.0 83.9–98.6ROR 92.6 · calibrated p 2e-7 ✓ | 77.6 EB05 72.8 · IC025 +6.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=528 | NCT00716625: 57/1,673 (3.4%) on Sunitinib Malate |
| Eyelash discolouration | 30 | 83.9 57.1–123.3ROR 83.9 · calibrated p 1e-6 ✓ | 69.4 EB05 51.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | ♀ 60% (drug 35%) | not reported in cached trials |
| Malignant urinary tract neoplasm | 16 | 82.1 48.5–139.0ROR 82.1 · calibrated p 2e-6 ✓ | 65.8 EB05 43.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Pancreatic neuroendocrine tumour | 79 | 75.3 59.5–95.4ROR 75.5 · calibrated p 1e-6 ✓ | 65.1 EB05 53.9 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=64 | not reported in cached trials |
| Pancreatic neuroendocrine tumour metastatic | 21 | 51.6 33.0–80.8ROR 51.6 · calibrated p 3e-5 ✓ | 45.3 EB05 31.3 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=16 | not reported in cached trials |
| Plantar erythema | 21 | 50.0 32.0–78.2ROR 50.0 · calibrated p 3e-5 ✓ | 44.1 EB05 30.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Nephritic syndrome | 25 | 47.2 31.3–71.0ROR 47.2 · calibrated p 4e-5 ✓ | 42.1 EB05 30.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 35%) · 100% clinician | not reported in cached trials |
| Anal injury | 14 | 47.1 27.3–81.4ROR 47.1 · calibrated p 7e-5 ✓ | 41.1 EB05 26.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Palmar-plantar erythrodysaesthesia syndrome | 1,454 | 35.5 33.7–37.4ROR 36.9 · calibrated p 8e-5 ✓ | 33.3 EB05 31.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 | NCT00716625: 24/1,673 (1.4%) on Sunitinib Malate (serious AE) |
| Tumour rupture | 34 | 35.1 24.8–49.6ROR 35.1 · calibrated p 2e-4 ✓ | 32.4 EB05 24.3 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=34 | not reported in cached trials |
| Neoplasm progression | 2,019 | 32.7 31.3–34.2ROR 34.4 · calibrated p 1e-4 ✓ | 30.8 EB05 29.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.1 | NCT00716625: 23/1,673 (1.4%) on Sunitinib Malate (serious AE) |
| Mouth injury | 79 | 29.3 23.3–36.7ROR 29.3 · calibrated p 3e-4 ✓ | 27.6 EB05 22.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=77 · 100% consumer | not reported in cached trials |
| Oral pain | 1,147 | 28.8 27.2–30.6ROR 29.7 · calibrated p 3e-4 ✓ | 27.4 EB05 26.1 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.8 | NCT00326898: 1/628 (0.2%) on Sunitinib Malate; 1/625 (0.2%) control (serious AE) |
| Renal cell carcinoma stage unspecified | 29 | 28.4 19.6–41.3ROR 28.4 · calibrated p 5e-4 ✓ | 26.6 EB05 19.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=29 · 100% clinician | not reported in cached trials |
| Tumour compression | 15 | 26.5 15.8–44.5ROR 26.5 · calibrated p 0.001 ✓ | 24.5 EB05 15.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Hyperkeratosis | 238 | 24.1 21.1–27.4ROR 24.2 · calibrated p 8e-4 ✓ | 23.0 EB05 20.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=148 | not reported in cached trials |
| Cardiopulmonary failure | 164 | 23.4 20.0–27.4ROR 23.5 · calibrated p 1e-3 ✓ | 22.4 EB05 19.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=164 | not reported in cached trials |
| Tumour pain | 53 | 22.3 17.0–29.4ROR 22.4 · calibrated p 0.001 ✓ | 21.3 EB05 16.9 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=53 · 74% consumer | not reported in cached trials |
| Hair colour changes | 465 | 20.6 18.8–22.5ROR 20.8 · calibrated p 0.002 ✓ | 19.8 EB05 18.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=283 | not reported in cached trials |
| Second primary malignancy | 294 | 19.6 17.5–22.1ROR 19.8 · calibrated p 0.002 ✓ | 18.9 EB05 17.2 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 | not reported in cached trials |
| Clear cell renal cell carcinoma | 24 | 19.4 12.9–29.2ROR 19.5 · calibrated p 0.003 ✓ | 18.5 EB05 12.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | not reported in cached trials |
| Disease progression | 3,912 | 18.4 17.8–18.9ROR 20.3 · calibrated p 0.002 ✓ | 17.8 EB05 17.3 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 10.6 | NCT00716625: 187/1,673 (11.2%) on Sunitinib Malate (serious AE) |
| Hydrothorax | 27 | 17.9 12.2–26.3ROR 17.9 · calibrated p 0.004 ✓ | 17.1 EB05 12.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 0% (drug 35%) | not reported in cached trials |
| Hypogeusia | 60 | 16.9 13.1–21.9ROR 16.9 · calibrated p 0.005 ✓ | 16.3 EB05 13.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=43 | not reported in cached trials |
| Tumour necrosis | 32 | 16.8 11.8–23.9ROR 16.8 · calibrated p 0.006 ✓ | 16.1 EB05 11.8 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=32 · ♀ 0% (drug 35%) · 100% clinician | not reported in cached trials |
| Anal ulcer | 24 | 16.2 10.8–24.4ROR 16.2 · calibrated p 0.007 ✓ | 15.4 EB05 10.6 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=24 | not reported in cached trials |
| Tongue blistering | 59 | 14.5 11.2–18.7ROR 14.5 · calibrated p 0.009 ✓ | 14.0 EB05 11.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=31 | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 588 | 14.5 13.3–15.7ROR 14.7 · calibrated p 0.008 ✓ | 14.1 EB05 13.2 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 | NCT00716625: 1/1,673 (0.1%) on Sunitinib Malate (serious AE) |
| Gingival discomfort | 17 | 14.3 8.8–23.1ROR 14.3 · calibrated p 0.013 ✓ | 13.1 EB05 8.1 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Thyroid function test abnormal | 108 | 14.2 11.7–17.2ROR 14.3 · calibrated p 0.009 ✓ | 13.8 EB05 11.7 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=72 | not reported in cached trials |
| Reversible posterior leukoencephalopathy syndrome | 20 | 13.9 8.9–21.6ROR 13.9 · calibrated p 0.013 ✓ | 12.8 EB05 8.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=20 | not reported in cached trials |
| Ageusia (loss of taste) | 623 | 13.7 12.6–14.8ROR 13.9 · calibrated p 0.010 ✓ | 13.3 EB05 12.5 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.8 | not reported in cached trials |
| Tongue discomfort | 103 | 13.4 11.1–16.3ROR 13.5 · calibrated p 0.011 ✓ | 13.0 EB05 11.0 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious n=54 | not reported in cached trials |
| Exposed bone in jaw | 53 | 13.3 10.1–17.4ROR 13.3 · calibrated p 0.013 ✓ | 12.8 EB05 10.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=52 | not reported in cached trials |
| Stomatitis (mouth sores) | 1,466 | 13.3 12.6–14.0ROR 13.7 · calibrated p 0.010 ✓ | 13.0 EB05 12.4 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 | NCT00326898: 2/625 (0.3%) control (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Sunitinib Malate 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 (7 of 40 signal terms matched).
- NCT00326898 — Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery (N=1943, PHASE3; 153 AE terms posted; arms: Arm A (Sunitinib + Sorafenib Placebo); Arm B (Sorafenib + Sunitinib Placebo); Arm C (Sunitinib Placebo + Sorafenib Pla)
- NCT00716625 — Special Investigation For Renal Cell Carcinoma (RCC) Of Sunitinib Malate (Regulatory Post Marketing Commitment (N=1674, phase n/a; 420 AE terms posted; arms: Sunitinib Malate)
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 | 7,433 | 4.7 4.6–4.8ROR 5.5 · calibrated p 0.185 | 4.6 EB05 4.5 · IC025 +2.2 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 3.5 | NCT00716625: 14/1,673 (0.8%) on Sunitinib Malate (serious AE) |
| Diarrhoea (diarrhea) | 4,418 | 3.7 3.6–3.8ROR 4.0 · calibrated p 0.369 | 3.7 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | NCT00326898: 2/626 (0.3%) on Sunitinib Malate; 57/625 (9.1%) control (serious AE) |
| Fatigue (tiredness) | 4,190 | 2.9 2.8–3.0ROR 3.1 · calibrated p 0.585 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | NCT00326898: 15/626 (2.4%) on Sunitinib Malate; 108/625 (17.3%) control (serious AE) |
| Disease progression | 3,912 | 18.4 17.8–18.9ROR 20.3 · calibrated p 0.002 ✓ | 17.8 EB05 17.3 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 10.6 | NCT00716625: 187/1,673 (11.2%) on Sunitinib Malate (serious AE) |
| Nausea | 3,121 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.939 | 2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00326898: 5/628 (0.8%) on Sunitinib Malate; 22/625 (3.5%) control (serious AE) |
| Asthenia (weakness) | 2,462 | 3.5 3.4–3.7ROR 3.7 · calibrated p 0.438 | 3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | NCT00716625: 3/1,673 (0.2%) on Sunitinib Malate (serious AE) |
| Decreased appetite (loss of appetite) | 2,317 | 5.4 5.2–5.6ROR 5.7 · calibrated p 0.172 | 5.4 EB05 5.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | NCT00716625: 44/1,673 (2.6%) on Sunitinib Malate (serious AE) |
| Vomiting | 2,210 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.760 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | NCT00326898: 1/626 (0.2%) on Sunitinib Malate; 11/625 (1.8%) control (serious AE) |
| Neoplasm progression | 2,019 | 32.7 31.3–34.2ROR 34.4 · calibrated p 1e-4 ✓ | 30.8 EB05 29.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.1 | NCT00716625: 23/1,673 (1.4%) on Sunitinib Malate (serious AE) |
| Hypertension (high blood pressure) | 1,803 | 4.6 4.4–4.8ROR 4.8 · calibrated p 0.261 | 4.6 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.5 | NCT00326898: 15/626 (2.4%) on Sunitinib Malate; 104/625 (16.6%) control (serious AE) |
| Dysgeusia (altered taste) | 1,696 | 12.4 11.9–13.0ROR 13.0 · calibrated p 0.013 ✓ | 12.2 EB05 11.7 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.0 | NCT00716625: 2/1,673 (0.1%) on Sunitinib Malate (serious AE) |
| Weight decreased (weight loss) | 1,588 | 3.1 2.9–3.2ROR 3.2 · calibrated p 0.579 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | NCT00326898: 2/626 (0.3%) control (serious AE) |
| Malaise (feeling unwell) | 1,583 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.930 | 1.9 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.8 | NCT00716625: 37/1,673 (2.2%) on Sunitinib Malate (serious AE) |
| Stomatitis (mouth sores) | 1,466 | 13.3 12.6–14.0ROR 13.7 · calibrated p 0.010 ✓ | 13.0 EB05 12.4 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 | NCT00326898: 2/625 (0.3%) control (serious AE) |
| Palmar-plantar erythrodysaesthesia syndrome | 1,454 | 35.5 33.7–37.4ROR 36.9 · calibrated p 8e-5 ✓ | 33.3 EB05 31.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 | NCT00716625: 24/1,673 (1.4%) on Sunitinib Malate (serious AE) |
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.
- Renal cell carcinoma stage iv — n=26, PRR 157.9
- Eyelash discolouration — n=30, PRR 83.9
- Plantar erythema — n=21, PRR 50.0
- Nephritic syndrome — n=25, PRR 47.2
- Palmar-plantar erythrodysaesthesia syndrome — n=1,454, PRR 35.5 (also seen in trial arm)
- Neoplasm progression — n=2,019, PRR 32.7 (also seen in trial arm)
- Mouth injury — n=79, PRR 29.3
- Renal cell carcinoma stage unspecified — n=29, PRR 28.4
- Hyperkeratosis — n=238, PRR 24.1
- Cardiopulmonary failure — n=164, PRR 23.4
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 Sunitinib Malate?
In FDA FAERS, the most frequently co-reported reaction terms for Sunitinib Malate are diarrhoea, fatigue, nausea, asthenia, decreased appetite, vomiting. 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 Sunitinib Malate have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: HEPATOTOXICITY Hepatotoxicity may be severe, and in some cases, fatal. Monitor hepatic function and interrupt, dose reduce, or discontinue sunitinib malate capsules as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning.
Do FAERS signals prove that Sunitinib Malate 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 04d34bce-1296-d2b9-e063-6394a90a7018, effective 20240910; matched on
openfda.generic_name.exact:"SUNITINIB MALATE") - 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, 1,140 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
SUNITINIB MALATE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.