Drug · FAERS side-effect profile with label screen
Rituximab-Abbs side effects: what 4,946 FDA adverse event reports show
Drug class
CD20-directed Cytolytic Antibody
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Truxima
openFDA label
Who reports
4,946 reports · 73% serious · 516 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
TRUXIMA (rituximab-abbs) is a CD20-directed cytolytic antibody indicated for the treatment of adult patients with: Non-Hodgkin's Lymphoma (NHL) ( 1.1 ). Relapsed or refractory, low grade or follicular, CD20-positive B-cell NHL as a single agent. Previo.
FDA label, Indications and Usage
What it is
Rituximab-abbs is a genetically engineered chimeric murine/human monoclonal IgG1 kappa antibody directed against the CD20 antigen. Rituximab-abbs has an approximate molecular weight of 145 kD. Rituximab-abbs is produced by mammalian cell (Chinese Hamster Ovary) suspension culture in a nutrient medium.
FDA label, Description section
Boxed warning
FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS RE.
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 — boxed warning 1Labeled (related wording) 3Likely indication confounding 3Reporting / coding artifact 6Lab value / disease marker 1Not in label — unassessed 26
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 (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. 224 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 |
|---|---|---|---|---|---|---|
| Helicobacter infection | 132 | 55.6 46.9–65.9ROR 57.1 · χ² 6,934 / p <1e-300 | 54.5 EB05 47.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 45.8 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Pemphigus | 130 | 44.8 37.8–53.1ROR 46.0 · χ² 5,467 / p <1e-300 | 44.1 EB05 38.1 · IC025 +5.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 35.1 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Poor venous access | 100 | 41.5 34.1–50.4ROR 42.3 · χ² 3,872 / p <1e-300 | 40.8 EB05 34.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=97 | no trial data cached |
| Hand deformity | 122 | 39.9 33.5–47.6ROR 40.9 · χ² 4,547 / p <1e-300 | 39.3 EB05 33.8 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 34.0 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Intentional dose omission | 240 | 37.5 33.2–42.5ROR 39.4 · χ² 8,433 / p <1e-300 | 37.1 EB05 33.3 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 53.9 | no trial data cached |
| Folliculitis | 81 | 33.5 27.0–41.6ROR 34.0 · χ² 2,503 / p <1e-300 | 33.0 EB05 27.4 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 30.9 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Pericarditis | 121 | 31.0 26.0–37.0ROR 31.8 · χ² 3,460 / p <1e-300 | 30.6 EB05 26.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · ♀ 99% (drug 65%) · 98% clinician | no trial data cached |
| Synovitis | 129 | 30.5 25.7–36.2ROR 31.3 · χ² 3,630 / p <1e-300 | 30.2 EB05 26.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 25.1 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Hypercholesterolaemia | 62 | 27.6 21.6–35.4ROR 28.0 · χ² 1,556 / p <1e-300 | 27.3 EB05 22.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 23.1 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Bursitis | 74 | 26.2 20.8–32.8ROR 26.5 · χ² 1,755 / p <1e-300 | 25.8 EB05 21.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 24.2 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 129 | 24.6 20.7–29.2ROR 25.2 · χ² 2,883 / p <1e-300 | 24.4 EB05 21.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 28.0 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Inability to afford medication | 55 | 23.8 18.3–31.0ROR 24.1 · χ² 1,175 / p 9e-258 | 23.5 EB05 18.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=54 | no trial data cached |
| Autoimmune disorder | 47 | 20.9 15.7–27.8ROR 21.1 · χ² 867 / p 6e-191 | 20.7 EB05 16.1 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.6 · ♀ 100% (drug 65%) | no trial data cached |
| Systemic lupus erythematosus | 156 | 18.8 16.1–21.9ROR 19.4 · χ² 2,600 / p <1e-300 | 18.7 EB05 16.3 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.2 · ♀ 100% (drug 65%) | no trial data cached |
| Insurance issue | 64 | 18.3 14.4–23.4ROR 18.6 · χ² 1,028 / p 7e-226 | 18.2 EB05 14.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 26.6 | no trial data cached |
| Joint range of motion decreased | 57 | 18.2 14.0–23.5ROR 18.4 · χ² 903 / p 9e-199 | 18.0 EB05 14.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 17.9 · ♀ 100% (drug 65%) · 98% clinician | no trial data cached |
| Wound infection | 45 | 17.6 13.2–23.6ROR 17.8 · χ² 686 / p 1e-151 | 17.4 EB05 13.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 14.9 · ♀ 100% (drug 65%) · 91% clinician | no trial data cached |
| Wound | 110 | 16.8 14.0–20.3ROR 17.2 · χ² 1,618 / p <1e-300 | 16.7 EB05 14.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 15.6 · ♀ 99% (drug 65%) · 96% clinician | no trial data cached |
| Contraindicated product administered | 118 | 16.6 13.9–19.9ROR 17.0 · χ² 1,715 / p <1e-300 | 16.5 EB05 14.2 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 16.2 · ♀ 100% (drug 65%) · 97% clinician | no trial data cached |
| Intentional product use issue | 332 | 16.1 14.5–17.8ROR 17.1 · χ² 4,676 / p <1e-300 | 16.0 EB05 14.6 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 · ♀ 96% (drug 65%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 237 | 15.3 13.5–17.3ROR 16.0 · χ² 3,143 / p <1e-300 | 15.2 EB05 13.6 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 13.3 · ♀ 88% (drug 65%) · 90% clinician | no trial data cached |
| Irritable bowel syndrome | 72 | 14.3 11.4–18.0ROR 14.5 · χ² 877 / p 4e-193 | 14.2 EB05 11.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 · ♀ 100% (drug 65%) · 99% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 36 | 13.8 10.0–19.1ROR 13.9 · χ² 414 / p 3e-92 | 13.5 EB05 10.0 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 12.0 · ♀ 100% (drug 65%) | no trial data cached |
| Obesity | 51 | 13.6 10.3–17.9ROR 13.7 · χ² 581 / p 1e-128 | 13.4 EB05 10.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 · ♀ 100% (drug 65%) · 100% clinician | no trial data cached |
| Hip arthroplasty | 47 | 13.2 9.9–17.5ROR 13.3 · χ² 515 / p 3e-114 | 12.9 EB05 9.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · ♀ 100% (drug 65%) · 94% clinician | no trial data cached |
| Fibromyalgia | 68 | 11.9 9.4–15.1ROR 12.1 · χ² 667 / p 2e-147 | 11.7 EB05 9.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 · ♀ 100% (drug 65%) · 99% clinician | no trial data cached |
| Coeliac disease | 27 | 11.7 8.0–17.0ROR 11.7 · χ² 253 / p 3e-57 | 11.0 EB05 7.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · ♀ 100% (drug 65%) · 100% clinician | no trial data cached |
| Off label use (used outside approved label) | 2,328 | 11.4 11.1–11.7ROR 20.7 · χ² 22,971 / p <1e-300 | 11.4 EB05 11.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 | no trial data cached |
| Impaired healing | 85 | 11.0 8.9–13.6ROR 11.2 · χ² 762 / p 5e-168 | 10.8 EB05 8.9 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 10.4 · ♀ 99% (drug 65%) · 94% clinician | no trial data cached |
| Prescribed overdose | 50 | 11.0 8.3–14.5ROR 11.1 · χ² 443 / p 1e-98 | 10.6 EB05 8.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 · ♀ 100% (drug 65%) · 90% clinician | no trial data cached |
| Sciatica | 40 | 10.7 7.9–14.6ROR 10.8 · χ² 342 / p 1e-76 | 10.2 EB05 7.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · ♀ 100% (drug 65%) · 90% clinician | no trial data cached |
| Type 2 diabetes mellitus | 81 | 10.2 8.2–12.6ROR 10.3 · χ² 662 / p 3e-146 | 9.9 EB05 8.2 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.5 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Underdose | 175 | 10.2 8.8–11.8ROR 10.5 · χ² 1,440 / p <1e-300 | 10.1 EB05 8.8 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 28.6 · ♀ 100% (drug 65%) | no trial data cached |
| Joint dislocation | 25 | 10.1 6.8–14.9ROR 10.1 · χ² 195 / p 1e-44 | 9.3 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Rheumatoid arthritis | 253 | 9.5 8.4–10.7ROR 10.0 · χ² 1,923 / p <1e-300 | 9.4 EB05 8.5 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.2 · ♀ 97% (drug 65%) | no trial data cached |
| Back injury | 24 | 9.4 6.3–14.0ROR 9.5 · χ² 172 / p 1e-39 | 8.5 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Laryngitis | 24 | 9.4 6.3–14.0ROR 9.4 · χ² 171 / p 2e-39 | 8.5 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Pulmonary fibrosis | 41 | 9.1 6.7–12.4ROR 9.2 · χ² 288 / p 8e-65 | 8.6 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Arthropathy | 119 | 9.1 7.6–10.8ROR 9.3 · χ² 846 / p 3e-186 | 8.9 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Osteoarthritis | 89 | 8.9 7.2–10.9ROR 9.0 · χ² 616 / p 3e-136 | 8.6 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 96% (drug 65%) · 92% clinician | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 2,328 | 11.4 11.1–11.7ROR 20.7 · χ² 22,971 / p <1e-300 | 11.4 EB05 11.0 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 | no trial data cached |
| Intentional product use issue | 332 | 16.1 14.5–17.8ROR 17.1 · χ² 4,676 / p <1e-300 | 16.0 EB05 14.6 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 · ♀ 96% (drug 65%) | no trial data cached |
| Hypertension (high blood pressure) | 281 | 5.6 5.0–6.3ROR 5.9 · χ² 1,073 / p 1e-235 | 5.6 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · ♀ 93% (drug 65%) | no trial data cached |
| Rheumatoid arthritis | 253 | 9.5 8.4–10.7ROR 10.0 · χ² 1,923 / p <1e-300 | 9.4 EB05 8.5 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 9.2 · ♀ 97% (drug 65%) | no trial data cached |
| Intentional dose omission | 240 | 37.5 33.2–42.5ROR 39.4 · χ² 8,433 / p <1e-300 | 37.1 EB05 33.3 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 53.9 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 237 | 15.3 13.5–17.3ROR 16.0 · χ² 3,143 / p <1e-300 | 15.2 EB05 13.6 · IC025 +3.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 13.3 · ♀ 88% (drug 65%) · 90% clinician | no trial data cached |
| Pyrexia (fever) | 227 | 2.8 2.4–3.2ROR 2.9 · χ² 261 / p 5e-59 | 2.8 EB05 2.5 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Rash | 226 | 2.2 1.9–2.5ROR 2.3 · χ² 152 / p 4e-35 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 3.8 · ♀ 89% (drug 65%) | no trial data cached |
| Arthralgia (joint pain) | 198 | 2.0 1.8–2.3ROR 2.1 · χ² 104 / p 1e-24 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.7 · ♀ 94% (drug 65%) | no trial data cached |
| Hypersensitivity (allergic reaction) | 188 | 4.3 3.7–5.0ROR 4.4 · χ² 477 / p 4e-106 | 4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 · ♀ 99% (drug 65%) | no trial data cached |
| Condition aggravated | 181 | 2.5 2.2–2.9ROR 2.6 · χ² 170 / p 3e-39 | 2.5 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · ♀ 95% (drug 65%) | no trial data cached |
| Pruritus (itching) | 180 | 2.0 1.7–2.3ROR 2.1 · χ² 93 / p 2e-22 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 3.3 · ♀ 85% (drug 65%) | no trial data cached |
| Underdose | 175 | 10.2 8.8–11.8ROR 10.5 · χ² 1,440 / p <1e-300 | 10.1 EB05 8.8 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 28.6 · ♀ 100% (drug 65%) | no trial data cached |
| Systemic lupus erythematosus | 156 | 18.8 16.1–21.9ROR 19.4 · χ² 2,600 / p <1e-300 | 18.7 EB05 16.3 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.2 · ♀ 100% (drug 65%) | no trial data cached |
| Joint swelling | 147 | 5.2 4.4–6.1ROR 5.3 · χ² 494 / p 1e-109 | 5.1 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · ♀ 98% (drug 65%) · 93% clinician | 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.
- Helicobacter infection — n=132, PRR 55.6
- Poor venous access — n=100, PRR 41.5
- Hand deformity — n=122, PRR 39.9
- Pericarditis — n=121, PRR 31.0
- Synovitis — n=129, PRR 30.5
- Hypercholesterolaemia — n=62, PRR 27.6
- Bursitis — n=74, PRR 26.2
- Glossodynia — n=129, PRR 24.6
- Inability to afford medication — n=55, PRR 23.8
- Insurance issue — n=64, PRR 18.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Rituximab ↔ Serious infection.
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 Rituximab-Abbs?
In FDA FAERS, the most frequently co-reported reaction terms for Rituximab-Abbs are hypertension, rheumatoid arthritis, infusion related reaction, pyrexia, rash, arthralgia. 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 Rituximab-Abbs have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS RE.
Do FAERS signals prove that Rituximab-Abbs 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 9af3ddc7-4217-417a-ac89-8704edc5bc44, effective 20260713; matched on
openfda.generic_name.exact:"RITUXIMAB-ABBS") - 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, 264 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.