Drug · FAERS side-effect profile with label screen
Axitinib side effects: what 19,366 FDA adverse event reports show
Brand names
Inlyta
openFDA label
Who reports
19,366 reports · 66% serious · 3,908 with death outcome · 29% female
openFDA FAERS counts, all years, deduplication not applied
Used for
INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy.
FDA label, Indications and Usage
What it is
INLYTA (axitinib) is a kinase inhibitor. Axitinib has the chemical name N-methyl-2-[3-((E)-2-pyridin-2-yl-vinyl)-1H-indazol-6-ylsulfanyl]-benzamide.
FDA label, Description section
Boxed warning
None in the current 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 7Labeled (related wording) 7Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 21
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.
- 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. 985 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Body surface area decreased | 12 | 185.7 100.6–342.7ROR 185.8 · χ² 1,723 / p <1e-300 | 126.9 EB05 77.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Metastatic renal cell carcinoma | 209 | 137.6 119.2–158.8ROR 139.0 · χ² 24,980 / p <1e-300 | 120.6 EB05 107.5 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=169 | NCT00700258: 4/237 (1.7%) on Axitinib (serious AE) |
| Malignant urinary tract neoplasm | 12 | 119.7 65.9–217.4ROR 119.8 · χ² 1,166 / p 8e-256 | 92.4 EB05 56.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Renal cancer metastatic | 46 | 67.8 50.4–91.3ROR 68.0 · χ² 2,785 / p <1e-300 | 62.3 EB05 48.6 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=31 | NCT00700258: 1/237 (0.4%) on Axitinib (serious AE) |
| Renal cell carcinoma | 244 | 56.3 49.6–64.0ROR 57.0 · χ² 12,545 / p <1e-300 | 53.3 EB05 48.0 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications | serious n=173 | NCT00700258: 7/237 (3.0%) on Axitinib (serious AE) |
| Clear cell renal cell carcinoma | 27 | 44.4 30.2–65.3ROR 44.5 · χ² 1,059 / p 2e-232 | 41.5 EB05 30.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=22 | NCT00700258: 1/605 (0.2%) on Axitinib (serious AE) |
| Neoplasm progression | 1,323 | 42.4 40.2–44.7ROR 45.4 · χ² 51,468 / p <1e-300 | 40.8 EB05 39.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 29.2 | NCT00700258: 4/237 (1.7%) on Axitinib (serious AE) |
| Immune-mediated hepatic disorder | 70 | 41.1 32.4–52.2ROR 41.3 · χ² 2,601 / p <1e-300 | 39.3 EB05 32.1 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=70 | not reported in cached trials |
| Nephrectomy | 43 | 32.3 23.9–43.7ROR 32.4 · χ² 1,236 / p 5e-271 | 31.0 EB05 24.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=41 | NCT00700258: 1/702 (0.1%) on Axitinib (serious AE) |
| Immune-mediated renal disorder | 10 | 28.4 15.2–53.2ROR 28.4 · χ² 231 / p 1e-52 | 26.3 EB05 15.0 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | not reported in cached trials |
| Immune-mediated myocarditis | 34 | 24.4 17.4–34.3ROR 24.5 · χ² 725 / p 7e-160 | 23.6 EB05 17.7 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=34 · 94% clinician | not reported in cached trials |
| Immune-mediated nephritis | 10 | 24.4 13.1–45.7ROR 24.4 · χ² 197 / p 4e-45 | 22.7 EB05 12.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Palmar-plantar erythrodysaesthesia syndrome | 452 | 21.3 19.4–23.4ROR 21.8 · χ² 8,573 / p <1e-300 | 20.9 EB05 19.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 | NCT00700258: 2/237 (0.8%) on Axitinib (serious AE) |
| Dysphonia | 1,010 | 19.0 17.9–20.2ROR 20.0 · χ² 16,987 / p <1e-300 | 18.7 EB05 17.8 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.4 | NCT00700258: 19/237 (8.0%) on Axitinib |
| Autoimmune colitis | 11 | 18.8 10.4–34.2ROR 18.8 · χ² 165 / p 4e-38 | 17.4 EB05 9.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=11 | not reported in cached trials |
| Immune-mediated hypothyroidism | 18 | 18.4 11.6–29.4ROR 18.4 · χ² 275 / p 5e-62 | 17.6 EB05 11.5 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | not reported in cached trials |
| Product ineffective | 11 | 17.5 9.6–31.7ROR 17.5 · χ² 152 / p 3e-35 | 16.0 EB05 8.5 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious n=11 | not reported in cached trials |
| Cancer pain | 39 | 16.7 12.2–22.9ROR 16.7 · χ² 551 / p 4e-122 | 16.3 EB05 12.3 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=31 | NCT00700258: 1/605 (0.2%) on Axitinib (serious AE) |
| Second primary malignancy | 125 | 16.5 13.8–19.7ROR 16.6 · χ² 1,780 / p <1e-300 | 16.2 EB05 14.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 | NCT00700258: 1/702 (0.1%) on Axitinib (serious AE) |
| Hand-foot-and-mouth disease | 12 | 16.4 9.3–29.0ROR 16.4 · χ² 156 / p 5e-36 | 15.0 EB05 8.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=6 | not reported in cached trials |
| Hyperkeratosis | 76 | 15.1 12.0–18.9ROR 15.1 · χ² 970 / p 2e-213 | 14.8 EB05 12.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=34 | not reported in cached trials |
| Aphonia | 186 | 14.6 12.7–16.9ROR 14.8 · χ² 2,317 / p <1e-300 | 14.4 EB05 12.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | NCT00700258: 2/237 (0.8%) on Axitinib |
| Protein urine | 12 | 14.5 8.2–25.7ROR 14.5 · χ² 136 / p 9e-32 | 13.0 EB05 7.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
| Encephalitis autoimmune | 17 | 14.4 8.9–23.3ROR 14.4 · χ² 196 / p 6e-45 | 13.4 EB05 8.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Thyroiditis | 38 | 14.0 10.2–19.2ROR 14.0 · χ² 439 / p 8e-98 | 13.5 EB05 10.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=36 · 92% clinician | NCT00700258: 1/702 (0.1%) on Axitinib |
| Immune-mediated hepatitis | 24 | 13.4 9.0–20.0ROR 13.4 · χ² 260 / p 1e-58 | 12.7 EB05 8.6 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=24 · 92% clinician | NCT02684006: 1/434 (0.2%) on Axitinib (serious AE) |
| Oral pain | 258 | 12.6 11.1–14.2ROR 12.7 · χ² 2,707 / p <1e-300 | 12.4 EB05 11.2 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | NCT00700258: 2/702 (0.3%) on Axitinib |
| Adrenocorticotropic hormone deficiency | 10 | 12.5 6.7–23.4ROR 12.6 · χ² 94 / p 2e-22 | 10.4 EB05 5.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Metastases to adrenals | 10 | 11.9 6.4–22.2ROR 11.9 · χ² 88 / p 3e-21 | 9.7 EB05 5.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=9 | NCT00700258: 1/605 (0.2%) on Axitinib |
| Thyroid hormones increased | 11 | 11.4 6.3–20.7ROR 11.4 · χ² 93 / p 2e-22 | 9.4 EB05 5.1 · IC025 +1.9 3/3 methods agree | Lab value / disease marker | serious n=5 | not reported in cached trials |
| Disease progression | 1,211 | 11.2 10.6–11.9ROR 11.9 · χ² 11,216 / p <1e-300 | 11.1 EB05 10.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | NCT00700258: 19/237 (8.0%) on Axitinib (serious AE) |
| Hypothyroidism | 315 | 10.8 9.7–12.1ROR 11.0 · χ² 2,770 / p <1e-300 | 10.7 EB05 9.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 | NCT00700258: 1/237 (0.4%) on Axitinib (serious AE) |
| Tumour pain | 13 | 10.7 6.2–18.5ROR 10.7 · χ² 104 / p 9e-25 | 9.0 EB05 5.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=11 | NCT00700258: 1/702 (0.1%) on Axitinib (serious AE) |
| Polycythaemia | 20 | 10.7 6.9–16.6ROR 10.7 · χ² 165 / p 5e-38 | 9.6 EB05 6.2 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=17 · 100% clinician | not reported in cached trials |
| Stomatitis (mouth sores) | 593 | 10.7 9.9–11.6ROR 11.0 · χ² 5,156 / p <1e-300 | 10.6 EB05 9.9 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | NCT00700258: 4/237 (1.7%) on Axitinib (serious AE) |
| Nephritis | 32 | 10.6 7.5–15.0ROR 10.6 · χ² 265 / p 7e-60 | 9.9 EB05 7.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=32 · ♀ 0% (drug 29%) · 100% clinician | NCT00700258: 1/605 (0.2%) on Axitinib (serious AE) |
| Proteinuria | 181 | 10.5 9.1–12.1ROR 10.6 · χ² 1,530 / p <1e-300 | 10.3 EB05 9.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 · 91% clinician | NCT00700258: 1/702 (0.1%) on Axitinib (serious AE) |
| Posterior reversible encephalopathy syndrome | 89 | 10.2 8.3–12.6ROR 10.3 · χ² 724 / p 1e-159 | 9.9 EB05 8.2 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.8 · ♀ 53% (drug 29%) | NCT00700258: 1/237 (0.4%) on Axitinib (serious AE) |
| Glossitis | 33 | 10.1 7.2–14.3ROR 10.1 · χ² 260 / p 8e-59 | 9.4 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=11 | NCT00700258: 1/702 (0.1%) on Axitinib |
| Protein urine present | 44 | 9.7 7.2–13.0ROR 9.7 · χ² 330 / p 4e-74 | 9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=30 | 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 Axitinib 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 (23 of 40 signal terms matched).
- NCT00700258 — Registry For Temsirolimus, Sunitinib, And Axitinib Treated Patients With Metastatic Renal Cell Carcinoma (mRCC (N=1520, phase n/a; 1111 AE terms posted; arms: mRCC - Temsirolimus; mRCC - Sunitinib; mRCC - Axitinib; MCL - Temsirolimus)
- NCT02684006 — A Study of Avelumab With Axitinib Versus Sunitinib In Advanced Renal Cell Cancer (JAVELIN Renal 101) (N=886, PHASE3; 426 AE terms posted; arms: Avelumab + Axitinib; Sunitinib)
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 | 2,666 | 3.4 3.2–3.5ROR 3.7 · χ² 4,590 / p <1e-300 | 3.4 EB05 3.2 · IC025 +1.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.9 | NCT00700258: 7/237 (3.0%) on Axitinib (serious AE) |
| Diarrhoea (diarrhea) | 2,578 | 4.4 4.2–4.5ROR 4.9 · χ² 6,839 / p <1e-300 | 4.3 EB05 4.2 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | NCT00700258: 13/237 (5.5%) on Axitinib (serious AE) |
| Fatigue (tiredness) | 2,115 | 3.0 2.8–3.1ROR 3.2 · χ² 2,828 / p <1e-300 | 2.9 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | NCT00700258: 2/237 (0.8%) on Axitinib (serious AE) |
| Hypertension (high blood pressure) | 1,326 | 6.8 6.5–7.2ROR 7.2 · χ² 6,590 / p <1e-300 | 6.8 EB05 6.5 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | NCT00700258: 1/605 (0.2%) on Axitinib (serious AE) |
| Neoplasm progression | 1,323 | 42.4 40.2–44.7ROR 45.4 · χ² 51,468 / p <1e-300 | 40.8 EB05 39.0 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 29.2 | NCT00700258: 4/237 (1.7%) on Axitinib (serious AE) |
| Disease progression | 1,211 | 11.2 10.6–11.9ROR 11.9 · χ² 11,216 / p <1e-300 | 11.1 EB05 10.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.2 | NCT00700258: 19/237 (8.0%) on Axitinib (serious AE) |
| Off label use (used outside approved label) | 1,206 | 1.5 1.4–1.6ROR 1.5 · χ² 213 / p 2e-48 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.7 | NCT00700258: 1/237 (0.4%) on Axitinib |
| Nausea | 1,143 | 1.6 1.5–1.7ROR 1.6 · χ² 245 / p 2e-55 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT00700258: 4/237 (1.7%) on Axitinib (serious AE) |
| Decreased appetite (loss of appetite) | 1,087 | 5.1 4.8–5.4ROR 5.3 · χ² 3,603 / p <1e-300 | 5.1 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | NCT00700258: 1/237 (0.4%) on Axitinib (serious AE) |
| Dysphonia | 1,010 | 19.0 17.9–20.2ROR 20.0 · χ² 16,987 / p <1e-300 | 18.7 EB05 17.8 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.4 | NCT00700258: 19/237 (8.0%) on Axitinib |
| Blood pressure increased | 851 | 6.0 5.7–6.5ROR 6.3 · χ² 3,582 / p <1e-300 | 6.0 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | NCT00700258: 1/237 (0.4%) on Axitinib (serious AE) |
| Weight decreased (weight loss) | 802 | 3.1 2.9–3.3ROR 3.2 · χ² 1,164 / p 2e-255 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | NCT00700258: 2/237 (0.8%) on Axitinib (serious AE) |
| Asthenia (weakness) | 761 | 2.2 2.0–2.4ROR 2.2 · χ² 501 / p 3e-111 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00700258: 3/237 (1.3%) on Axitinib (serious AE) |
| Headache | 604 | 1.0 1.0–1.1ROR 1.0 · χ² 1 / p 0.143 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.9 | NCT00700258: 1/237 (0.4%) on Axitinib (serious AE) |
| Stomatitis (mouth sores) | 593 | 10.7 9.9–11.6ROR 11.0 · χ² 5,156 / p <1e-300 | 10.6 EB05 9.9 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | NCT00700258: 4/237 (1.7%) on Axitinib (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.
- Metastatic renal cell carcinoma — n=209, PRR 137.6 (also seen in trial arm)
- Renal cancer metastatic — n=46, PRR 67.8 (also seen in trial arm)
- Clear cell renal cell carcinoma — n=27, PRR 44.4 (also seen in trial arm)
- Neoplasm progression — n=1,323, PRR 42.4 (also seen in trial arm)
- Nephrectomy — n=43, PRR 32.3 (also seen in trial arm)
- Palmar-plantar erythrodysaesthesia syndrome — n=452, PRR 21.3 (also seen in trial arm)
- Second primary malignancy — n=125, PRR 16.5 (also seen in trial arm)
- Hyperkeratosis — n=76, PRR 15.1
- Aphonia — n=186, PRR 14.6 (also seen in trial arm)
- Thyroiditis — n=38, PRR 14.0 (also seen in trial arm)
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 Axitinib?
In FDA FAERS, the most frequently co-reported reaction terms for Axitinib are diarrhoea, fatigue, hypertension, neoplasm progression, nausea, decreased appetite. 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 Axitinib have an FDA boxed warning?
No. The FDA label retrieved for Axitinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Axitinib 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 84137882-e000-47da-bd5b-fa76ab3c76f9, effective 20250219; matched on
openfda.generic_name.exact:"AXITINIB") - 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, 1,025 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
AXITINIB, 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.