Sorafenib side effects: what 20,648 FDA adverse event reports show

Sorafenib · 1,087 reaction terms · 86,231 drug–reaction co-reports · data 2026-09-14

Drug class

Kinase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Who reports

20,648 reports · 89% serious · 5,087 with death outcome · 29% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Sorafenib tablets are a kinase inhibitor indicated for the treatment of • Unresectable hepatocellular carcinoma ( 1.1 ) • Advanced renal cell carcinoma ( 1.2 ) • Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refra.

FDA label, Indications and Usage

What it is

Sorafenib, a kinase inhibitor, is the tosylate salt of sorafenib. Sorafenib tosylate has the chemical name 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)- N 2 -methylpyridine-2 carboxamide mono(4-methylbenzenesulfonate).

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 1Labeled (related wording) 15Likely indication confounding 3Lab value / disease marker 3Not in label — unassessed 18

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.
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, 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). 1,047 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
Hepatocellular carcinoma	1,899	337.6 321.0–354.9ROR 371.7 · calibrated p 1e-12 ✓	252.1 EB05 242.7 · IC025 +7.8 3/3 methods agree vs other Kinase Inhibitors: PRR 1,071.6 (882.4–1,301.5)	Likely indication confounding term in indications; also in warnings	serious PRR 163.1	no trial data cached
Protein induced by vitamin k absence or antagonist ii increased	17	309.5 179.7–533.0ROR 309.7 · calibrated p 1e-10 ✓	187.2 EB05 123.8 · IC025 +4.1 3/3 methods agree vs other Kinase Inhibitors: only this drug	Lab value / disease marker	serious n=17	no trial data cached
Alpha 1 foetoprotein increased	144	257.0 214.1–308.5ROR 258.8 · calibrated p 5e-11 ✓	199.3 EB05 173.5 · IC025 +6.6 3/3 methods agree vs other Kinase Inhibitors: only this drug	Lab value / disease marker	serious n=142	no trial data cached
Hepatic neoplasm malignant	391	227.2 203.7–253.3ROR 231.6 · calibrated p 1e-10 ✓	183.7 EB05 168.9 · IC025 +7.1 3/3 methods agree vs other Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=387 · 94% clinician	no trial data cached
Liver carcinoma ruptured	44	214.9 155.2–297.5ROR 215.3 · calibrated p 6e-10 ✓	164.6 EB05 127.6 · IC025 +5.4 3/3 methods agree vs other Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=44 · 100% clinician	no trial data cached
Renal cell carcinoma stage iv	16	165.1 97.3–280.2ROR 165.3 · calibrated p 2e-8 ✓	121.7 EB05 79.4 · IC025 +3.9 3/3 methods agree vs other Kinase Inhibitors: PRR 35.8 (19.3–66.4)	Labeled (related wording) related wording	serious n=16	no trial data cached
Parathyroid tumour malignant	16	143.0 84.7–241.5ROR 143.1 · calibrated p 5e-8 ✓	109.3 EB05 71.3 · IC025 +3.9 3/3 methods agree vs other Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=16	no trial data cached
Oral lichenoid reaction	10	122.1 63.3–235.4ROR 122.2 · calibrated p 4e-7 ✓	90.6 EB05 52.6 · IC025 +3.1 3/3 methods agree vs other Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=10	no trial data cached
Tumour embolism	18	108.6 66.8–176.5ROR 108.7 · calibrated p 3e-7 ✓	89.0 EB05 59.6 · IC025 +4.0 3/3 methods agree vs other Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=18	no trial data cached
Plantar erythema	23	104.7 68.1–160.8ROR 104.8 · calibrated p 3e-7 ✓	88.1 EB05 61.8 · IC025 +4.3 3/3 methods agree vs other Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=19 · ♀ 52% (drug 29%)	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	2,165	103.6 99.3–108.1ROR 115.6 · calibrated p 4e-8 ✓	93.9 EB05 90.6 · IC025 +6.5 3/3 methods agree vs other Kinase Inhibitors: PRR 56.4 (53.3–59.7)	Not in label — unassessed	serious PRR 73.8	no trial data cached
Tumour thrombosis	21	103.1 65.8–161.5ROR 103.2 · calibrated p 3e-7 ✓	86.4 EB05 59.6 · IC025 +4.2 3/3 methods agree vs other Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=21	no trial data cached
Poikiloderma	10	102.2 53.3–195.8ROR 102.2 · calibrated p 1e-6 ✓	79.3 EB05 46.0 · IC025 +3.0 3/3 methods agree vs other Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=10	no trial data cached
Thyroid cancer metastatic	24	93.5 61.5–142.0ROR 93.6 · calibrated p 6e-7 ✓	80.3 EB05 56.8 · IC025 +4.3 3/3 methods agree vs other Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=24 · ♀ 55% (drug 29%)	no trial data cached
Pneumonia adenoviral	14	80.1 46.5–138.0ROR 80.1 · calibrated p 3e-6 ✓	67.7 EB05 42.8 · IC025 +3.5 3/3 methods agree vs other Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=14	no trial data cached
Desmoid tumour	15	79.0 46.7–133.7ROR 79.1 · calibrated p 3e-6 ✓	67.3 EB05 43.3 · IC025 +3.6 3/3 methods agree vs other Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=15	no trial data cached
Hepatic rupture	15	72.9 43.2–123.1ROR 73.0 · calibrated p 5e-6 ✓	62.8 EB05 40.4 · IC025 +3.6 3/3 methods agree vs other Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=15	no trial data cached
Blood amylase increased	114	71.3 59.0–86.2ROR 71.7 · calibrated p 2e-6 ✓	65.9 EB05 56.4 · IC025 +5.4 3/3 methods agree vs other Kinase Inhibitors: PRR 1,147.3 (504.9–2,607.1)	Lab value / disease marker	serious n=108 · 100% clinician	no trial data cached
Palmoplantar keratoderma	47	70.9 52.7–95.2ROR 71.0 · calibrated p 2e-6 ✓	64.6 EB05 50.5 · IC025 +4.8 3/3 methods agree vs other Kinase Inhibitors: PRR 149.4 (87.7–254.4)	Not in label — unassessed	serious n=46	no trial data cached
Tumour rupture	36	70.7 50.4–99.1ROR 70.8 · calibrated p 3e-6 ✓	63.9 EB05 48.3 · IC025 +4.6 3/3 methods agree vs other Kinase Inhibitors: PRR 197.6 (100.6–388.2)	Labeled (related wording) related wording	serious n=36	no trial data cached
Renal cell carcinoma stage unspecified	35	65.7 46.7–92.5ROR 65.9 · calibrated p 4e-6 ✓	59.8 EB05 45.0 · IC025 +4.5 3/3 methods agree vs other Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=35	no trial data cached
Adenoviral hepatitis	14	65.2 38.0–111.9ROR 65.2 · calibrated p 1e-5 ✓	56.8 EB05 35.9 · IC025 +3.4 3/3 methods agree vs other Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=14	no trial data cached
Metastatic renal cell carcinoma	104	60.3 49.5–73.4ROR 60.6 · calibrated p 5e-6 ✓	56.4 EB05 47.8 · IC025 +5.2 3/3 methods agree vs other Kinase Inhibitors: PRR 11.0 (8.9–13.5)	Likely indication confounding term in indications; also in warnings	serious n=99	no trial data cached
Metastases to adrenals	51	59.6 45.0–79.1ROR 59.8 · calibrated p 6e-6 ✓	55.2 EB05 43.7 · IC025 +4.7 3/3 methods agree vs other Kinase Inhibitors: PRR 18.1 (13.3–24.8)	Not in label — unassessed	serious n=51	no trial data cached
Acute myeloid leukaemia recurrent	118	59.5 49.5–71.6ROR 59.9 · calibrated p 5e-6 ✓	55.8 EB05 47.8 · IC025 +5.2 3/3 methods agree vs other Kinase Inhibitors: PRR 139.7 (100.6–194.0)	Not in label — unassessed	serious n=118	no trial data cached
Renal cell carcinoma	273	59.5 52.7–67.1ROR 60.3 · calibrated p 4e-6 ✓	56.0 EB05 50.6 · IC025 +5.5 3/3 methods agree vs other Kinase Inhibitors: PRR 21.4 (18.7–24.6)	Likely indication confounding term in indications; also in warnings	serious n=268	no trial data cached
Food refusal	46	58.5 43.5–78.8ROR 58.6 · calibrated p 8e-6 ✓	54.2 EB05 42.3 · IC025 +4.6 3/3 methods agree vs other Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=46	no trial data cached
Coma hepatic	37	52.7 37.9–73.3ROR 52.8 · calibrated p 2e-5 ✓	48.9 EB05 37.1 · IC025 +4.4 3/3 methods agree vs other Kinase Inhibitors: PRR 744.7 (229.6–2,415.2)	Labeled (related wording) related wording	serious n=36	no trial data cached
Hepatic encephalopathy	454	51.9 47.2–56.9ROR 53.0 · calibrated p 1e-5 ✓	49.3 EB05 45.6 · IC025 +5.4 3/3 methods agree vs other Kinase Inhibitors: PRR 178.0 (148.3–213.6)	Labeled (related wording) related wording	serious PRR 32.0 · 91% clinician	no trial data cached
Hyperkeratosis	246	47.2 41.6–53.6ROR 47.8 · calibrated p 2e-5 ✓	45.0 EB05 40.5 · IC025 +5.2 3/3 methods agree vs other Kinase Inhibitors: PRR 38.5 (32.8–45.1)	Labeled adverse reaction exact term	serious n=208	no trial data cached
Therapeutic embolisation	14	47.2 27.6–80.6ROR 47.2 · calibrated p 6e-5 ✓	42.7 EB05 27.0 · IC025 +3.3 3/3 methods agree vs other Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=14	no trial data cached
Scrotal ulcer	11	44.1 24.1–80.6ROR 44.1 · calibrated p 1e-4 ✓	39.6 EB05 23.6 · IC025 +2.9 3/3 methods agree vs other Kinase Inhibitors: only this drug	Not in label — unassessed	–	no trial data cached
Abdominal cavity drainage	16	39.8 24.2–65.7ROR 39.9 · calibrated p 1e-4 ✓	36.8 EB05 24.0 · IC025 +3.3 3/3 methods agree vs other Kinase Inhibitors: only this drug	Not in label — unassessed	serious n=16	no trial data cached
Oesophageal varices haemorrhage	82	39.8 31.9–49.6ROR 39.9 · calibrated p 6e-5 ✓	38.0 EB05 31.6 · IC025 +4.6 3/3 methods agree vs other Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=83 · 90% clinician	no trial data cached
Hepatic cancer metastatic	32	39.1 27.5–55.6ROR 39.1 · calibrated p 1e-4 ✓	36.9 EB05 27.4 · IC025 +4.0 3/3 methods agree vs other Kinase Inhibitors: PRR 193.2 (95.0–393.0)	Labeled (related wording) related wording	serious n=32	no trial data cached
Keratoacanthoma	25	38.7 26.0–57.8ROR 38.8 · calibrated p 1e-4 ✓	36.4 EB05 25.9 · IC025 +3.8 3/3 methods agree vs other Kinase Inhibitors: PRR 14.4 (9.3–22.2)	Not in label — unassessed	serious n=24	no trial data cached
Gastric varices haemorrhage	12	38.1 21.4–67.9ROR 38.2 · calibrated p 2e-4 ✓	34.9 EB05 21.3 · IC025 +2.9 3/3 methods agree vs other Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=12	no trial data cached
Metastases to pancreas	16	38.0 23.0–62.5ROR 38.0 · calibrated p 2e-4 ✓	35.2 EB05 23.0 · IC025 +3.3 3/3 methods agree vs other Kinase Inhibitors: PRR 12.2 (7.1–20.9)	Not in label — unassessed	serious n=16	no trial data cached
Hepatic cancer recurrent	10	36.9 19.7–69.4ROR 37.0 · calibrated p 3e-4 ✓	33.6 EB05 19.4 · IC025 +2.7 3/3 methods agree vs other Kinase Inhibitors: only this drug	Labeled (related wording) related wording	serious n=10	no trial data cached
Metastases to lung	395	36.0 32.6–39.7ROR 36.6 · calibrated p 9e-5 ✓	34.7 EB05 31.9 · IC025 +4.9 3/3 methods agree vs other Kinase Inhibitors: PRR 10.8 (9.7–12.0)	Not in label — unassessed	serious PRR 22.6	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Diarrhoea (diarrhea)	2,958	4.7 4.5–4.8ROR 5.3 · calibrated p 0.204	4.7 EB05 4.5 · IC025 +2.2 3/3 methods agree vs other Kinase Inhibitors: PRR 5.9 (5.7–6.1)	Labeled adverse reaction exact term	serious PRR 4.7	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	2,165	103.6 99.3–108.1ROR 115.6 · calibrated p 4e-8 ✓	93.9 EB05 90.6 · IC025 +6.5 3/3 methods agree vs other Kinase Inhibitors: PRR 56.4 (53.3–59.7)	Not in label — unassessed	serious PRR 73.8	no trial data cached
Hepatocellular carcinoma	1,899	337.6 321.0–354.9ROR 371.7 · calibrated p 1e-12 ✓	252.1 EB05 242.7 · IC025 +7.8 3/3 methods agree vs other Kinase Inhibitors: PRR 1,071.6 (882.4–1,301.5)	Likely indication confounding term in indications; also in warnings	serious PRR 163.1	no trial data cached
Fatigue (tiredness)	1,796	2.4 2.2–2.5ROR 2.5 · calibrated p 0.822	2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree vs other Kinase Inhibitors: PRR 2.7 (2.6–2.8)	Labeled adverse reaction exact term	serious PRR 2.6	no trial data cached
Off label use (used outside approved label)	1,713	2.0 1.9–2.1ROR 2.1 · calibrated p 0.996	2.0 EB05 1.9 · IC025 +0.9 vs other Kinase Inhibitors: PRR 3.2 (3.0–3.3)	Reporting / coding artifact	serious PRR 2.3	no trial data cached
Rash	1,459	3.4 3.3–3.6ROR 3.6 · calibrated p 0.459	3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree vs other Kinase Inhibitors: PRR 7.4 (7.0–7.8)	Labeled adverse reaction exact term	serious PRR 3.9	no trial data cached
Death	1,457	1.7 1.6–1.8ROR 1.8 · calibrated p 0.814	1.7 EB05 1.6 · IC025 +0.7 vs other Kinase Inhibitors: PRR 1.9 (1.8–1.9)	Outcome field, not a reaction	serious PRR 1.1	no trial data cached
Decreased appetite (loss of appetite)	1,448	6.4 6.1–6.7ROR 6.8 · calibrated p 0.108	6.3 EB05 6.1 · IC025 +2.6 3/3 methods agree vs other Kinase Inhibitors: PRR 6.9 (6.6–7.3)	Labeled adverse reaction exact term	serious PRR 6.0	no trial data cached
Nausea	1,365	1.8 1.7–1.9ROR 1.8 · calibrated p 0.837	1.8 EB05 1.7 · IC025 +0.7 vs other Kinase Inhibitors: PRR 3.5 (3.3–3.7)	Labeled adverse reaction exact term	serious PRR 2.0	no trial data cached
Asthenia (weakness)	1,188	3.2 3.0–3.4ROR 3.4 · calibrated p 0.523	3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree vs other Kinase Inhibitors: PRR 4.9 (4.7–5.2)	Labeled adverse reaction exact term	serious PRR 2.8	no trial data cached
Hypertension (high blood pressure)	1,148	5.5 5.2–5.8ROR 5.8 · calibrated p 0.165	5.5 EB05 5.2 · IC025 +2.4 3/3 methods agree vs other Kinase Inhibitors: PRR 9.5 (8.9–10.1)	Labeled adverse reaction exact term	serious PRR 4.2	no trial data cached
Pyrexia (fever)	1,066	3.1 3.0–3.3ROR 3.2 · calibrated p 0.551	3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree vs other Kinase Inhibitors: PRR 6.3 (5.9–6.7)	Labeled adverse reaction exact term	serious PRR 2.5	no trial data cached
Vomiting	982	2.1 2.0–2.3ROR 2.2 · calibrated p 0.959	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree vs other Kinase Inhibitors: PRR 4.8 (4.5–5.1)	Labeled adverse reaction exact term	serious PRR 1.9	no trial data cached
Pain in extremity	967	3.3 3.1–3.5ROR 3.4 · calibrated p 0.498	3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree vs other Kinase Inhibitors: PRR 8.4 (7.9–9.0)	Labeled adverse reaction exact term	serious PRR 3.1	no trial data cached
Weight decreased (weight loss)	917	3.3 3.1–3.6ROR 3.5 · calibrated p 0.496	3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree vs other Kinase Inhibitors: PRR 5.9 (5.5–6.3)	Labeled (related wording) related wording	serious PRR 3.0	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.

Liver carcinoma ruptured — n=44, PRR 214.9
Palmar-plantar erythrodysaesthesia syndrome — n=2,165, PRR 103.6
Tumour thrombosis — n=21, PRR 103.1
Palmoplantar keratoderma — n=47, PRR 70.9
Metastases to adrenals — n=51, PRR 59.6
Acute myeloid leukaemia recurrent — n=118, PRR 59.5
Food refusal — n=46, PRR 58.5
Keratoacanthoma — n=25, PRR 38.7
Metastases to lung — n=395, PRR 36.0

✓ A hand-written Bradford Hill causality assessment exists for this drug: Sorafenib ↔ Hypertension.

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 Sorafenib?

In FDA FAERS, the most frequently co-reported reaction terms for Sorafenib are diarrhoea, palmar-plantar erythrodysaesthesia syndrome, hepatocellular carcinoma, fatigue, rash, 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 Sorafenib have an FDA boxed warning?

No. The FDA label retrieved for Sorafenib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Sorafenib 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 b5305e23-7bc6-44d8-b177-930c47d1653a, effective 20260211; matched on openfda.generic_name.exact:"SORAFENIB")
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, 1,087 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 2026-10-14. 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.