Drug · FAERS side-effect profile with label screen
Oseltamivir Acid side effects: what 1,657 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Oseltamivir Phosphate
openFDA label
Who reports
1,657 reports · 67% serious · 291 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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
Reporting / coding artifact 5Lab value / disease marker 3No label text to screen 32
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 59 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 |
|---|---|---|---|---|---|---|
| Appendicitis | 177 | 245.4 213.1–282.5ROR 274.5 · χ² 42,024 / p <1e-300 | 234.6 EB05 207.0 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 208.9 · ♀ 10% (drug 53%) · 97% clinician | no trial data cached |
| Ventricular fibrillation | 165 | 190.1 164.2–220.0ROR 211.0 · χ² 30,397 / p <1e-300 | 183.3 EB05 161.0 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 160.5 · ♀ 4% (drug 53%) · 96% clinician | no trial data cached |
| Cardiogenic shock | 170 | 152.4 132.0–175.9ROR 169.7 · χ² 25,127 / p <1e-300 | 148.1 EB05 130.3 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 128.7 · ♀ 11% (drug 53%) · 96% clinician | no trial data cached |
| Bacterial infection | 116 | 79.4 66.6–94.7ROR 85.3 · χ² 8,857 / p <1e-300 | 78.0 EB05 66.8 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 78.0 · ♀ 16% (drug 53%) · 97% clinician | no trial data cached |
| Ascites | 177 | 76.5 66.5–88.0ROR 85.5 · χ² 13,054 / p <1e-300 | 75.5 EB05 66.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.0 · ♀ 10% (drug 53%) · 97% clinician | no trial data cached |
| Incorrect route of product administration | 98 | 74.1 61.1–89.9ROR 78.7 · χ² 6,962 / p <1e-300 | 72.7 EB05 61.4 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious PRR 126.0 · ♀ 7% (drug 53%) · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 162 | 73.8 63.7–85.5ROR 81.7 · χ² 11,509 / p <1e-300 | 72.8 EB05 63.8 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.7 · ♀ 6% (drug 53%) · 96% clinician | no trial data cached |
| Hyperlipidaemia | 56 | 59.3 45.8–76.8ROR 61.4 · χ² 3,140 / p <1e-300 | 57.9 EB05 46.3 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.7 · ♀ 32% (drug 53%) · 96% clinician | no trial data cached |
| Neuralgia | 106 | 55.5 46.1–66.7ROR 59.2 · χ² 5,598 / p <1e-300 | 54.7 EB05 46.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.9 · ♀ 10% (drug 53%) · 97% clinician | no trial data cached |
| End stage renal disease | 63 | 43.4 34.0–55.3ROR 45.0 · χ² 2,559 / p <1e-300 | 42.7 EB05 34.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.0 · ♀ 30% (drug 53%) · 95% clinician | no trial data cached |
| Gout | 58 | 40.9 31.8–52.7ROR 42.4 · χ² 2,214 / p <1e-300 | 40.3 EB05 32.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.8 · ♀ 31% (drug 53%) · 97% clinician | no trial data cached |
| Ulcer | 50 | 39.8 30.3–52.3ROR 41.0 · χ² 1,847 / p <1e-300 | 39.1 EB05 30.8 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.0 · ♀ 16% (drug 53%) · 96% clinician | no trial data cached |
| Blood test abnormal | 42 | 37.9 28.1–51.1ROR 38.9 · χ² 1,470 / p <1e-300 | 37.2 EB05 28.7 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 49.5 · 98% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 165 | 37.2 32.2–43.0ROR 41.2 · χ² 5,776 / p <1e-300 | 37.0 EB05 32.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.6 · ♀ 5% (drug 53%) · 96% clinician | no trial data cached |
| Blood cholesterol increased | 135 | 36.7 31.2–43.1ROR 39.9 · χ² 4,648 / p <1e-300 | 36.4 EB05 31.5 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious PRR 46.4 · ♀ 15% (drug 53%) · 98% clinician | no trial data cached |
| Stress | 164 | 28.9 25.0–33.4ROR 31.9 · χ² 4,392 / p <1e-300 | 28.7 EB05 25.2 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.4 · ♀ 6% (drug 53%) · 96% clinician | no trial data cached |
| Swollen tongue | 69 | 28.0 22.2–35.2ROR 29.1 · χ² 1,765 / p <1e-300 | 27.7 EB05 22.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.0 · ♀ 100% (drug 53%) | no trial data cached |
| Chronic obstructive pulmonary disease | 107 | 26.0 21.6–31.2ROR 27.7 · χ² 2,547 / p <1e-300 | 25.8 EB05 22.0 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.9 · ♀ 16% (drug 53%) · 97% clinician | no trial data cached |
| Drug intolerance | 180 | 23.7 20.6–27.2ROR 26.4 · χ² 3,898 / p <1e-300 | 23.6 EB05 20.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 32.6 · 91% clinician | no trial data cached |
| Dry mouth | 150 | 23.5 20.1–27.3ROR 25.7 · χ² 3,208 / p <1e-300 | 23.3 EB05 20.4 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.5 · ♀ 16% (drug 53%) · 93% clinician | no trial data cached |
| Abdominal distension (bloating) | 183 | 22.3 19.4–25.6ROR 24.9 · χ² 3,711 / p <1e-300 | 22.2 EB05 19.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.2 · ♀ 13% (drug 53%) · 96% clinician | no trial data cached |
| Diabetes mellitus | 118 | 19.5 16.4–23.2ROR 20.9 · χ² 2,057 / p <1e-300 | 19.4 EB05 16.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.1 · ♀ 15% (drug 53%) · 97% clinician | no trial data cached |
| Angioedema (deep swelling of face/throat) | 67 | 19.2 15.2–24.3ROR 20.0 · χ² 1,139 / p 5e-250 | 19.1 EB05 15.5 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.4 · ♀ 100% (drug 53%) | no trial data cached |
| Sepsis (blood infection) | 169 | 19.2 16.6–22.1ROR 21.2 · χ² 2,903 / p <1e-300 | 19.1 EB05 16.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.5 · ♀ 6% (drug 53%) · 95% clinician | no trial data cached |
| General physical health deterioration | 171 | 18.8 16.3–21.7ROR 20.9 · χ² 2,882 / p <1e-300 | 18.8 EB05 16.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 18.7 · ♀ 11% (drug 53%) · 96% clinician | no trial data cached |
| Aspiration | 15 | 17.5 10.6–29.0ROR 17.7 · χ² 217 / p 2e-49 | 16.8 EB05 10.3 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 | no trial data cached |
| Sleep disorder | 94 | 17.0 14.0–20.7ROR 18.0 · χ² 1,402 / p <1e-300 | 16.9 EB05 14.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.7 · ♀ 12% (drug 53%) · 93% clinician | no trial data cached |
| Thrombosis | 106 | 16.6 13.8–20.0ROR 17.7 · χ² 1,545 / p <1e-300 | 16.6 EB05 14.1 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.7 · ♀ 9% (drug 53%) · 96% clinician | no trial data cached |
| Liver function test increased | 27 | 16.0 11.0–23.3ROR 16.3 · χ² 365 / p 1e-81 | 15.7 EB05 11.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.4 · ♀ 26% (drug 53%) · 96% clinician | no trial data cached |
| Intentional product misuse | 105 | 15.3 12.7–18.4ROR 16.3 · χ² 1,393 / p <1e-300 | 15.2 EB05 12.9 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 28.6 · ♀ 10% (drug 53%) · 92% clinician | no trial data cached |
| Pregnancy | 24 | 15.0 10.1–22.3ROR 15.2 · χ² 300 / p 2e-67 | 14.6 EB05 10.0 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | ♀ 100% (drug 53%) · 100% clinician | no trial data cached |
| Swelling | 110 | 14.9 12.4–17.9ROR 15.9 · χ² 1,418 / p <1e-300 | 14.8 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.1 · ♀ 11% (drug 53%) · 93% clinician | no trial data cached |
| Dysphonia | 68 | 14.7 11.7–18.6ROR 15.3 · χ² 858 / p 7e-189 | 14.6 EB05 11.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.4 · ♀ 95% (drug 53%) | no trial data cached |
| Swelling face | 75 | 14.6 11.7–18.2ROR 15.2 · χ² 938 / p 3e-206 | 14.5 EB05 11.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.8 · ♀ 96% (drug 53%) | no trial data cached |
| Pulmonary embolism (lung blood clot) | 106 | 14.0 11.7–16.9ROR 14.9 · χ² 1,276 / p 9e-280 | 14.0 EB05 11.8 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.1 · ♀ 11% (drug 53%) · 96% clinician | no trial data cached |
| Sputum discoloured | 10 | 13.4 7.2–24.8ROR 13.5 · χ² 102 / p 2e-24 | 11.5 EB05 5.7 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.0 | no trial data cached |
| Full blood count abnormal | 11 | 13.2 7.3–23.8ROR 13.3 · χ² 112 / p 2e-26 | 11.5 EB05 6.0 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 13.6 | no trial data cached |
| Aspartate aminotransferase increased | 55 | 13.1 10.1–17.0ROR 13.5 · χ² 604 / p 1e-133 | 12.9 EB05 10.2 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 12.8 · 98% clinician | no trial data cached |
| Obstructive airways disorder | 10 | 11.3 6.1–21.0ROR 11.4 · χ² 84 / p 2e-20 | 9.2 EB05 4.8 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 | no trial data cached |
| Micturition urgency | 10 | 11.2 6.0–20.7ROR 11.2 · χ² 83 / p 5e-20 | 9.1 EB05 4.7 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.8 | 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 |
|---|---|---|---|---|---|---|
| Vomiting | 264 | 7.1 6.4–8.0ROR 8.3 · χ² 1,414 / p <1e-300 | 7.0 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 · ♀ 31% (drug 53%) | no trial data cached |
| Abdominal pain | 194 | 10.6 9.2–12.0ROR 11.8 · χ² 1,686 / p <1e-300 | 10.5 EB05 9.3 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.5 · ♀ 19% (drug 53%) | no trial data cached |
| Abdominal distension (bloating) | 183 | 22.3 19.4–25.6ROR 24.9 · χ² 3,711 / p <1e-300 | 22.2 EB05 19.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.2 · ♀ 13% (drug 53%) · 96% clinician | no trial data cached |
| Drug intolerance | 180 | 23.7 20.6–27.2ROR 26.4 · χ² 3,898 / p <1e-300 | 23.6 EB05 20.8 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 32.6 · 91% clinician | no trial data cached |
| Constipation | 179 | 10.5 9.1–12.0ROR 11.6 · χ² 1,537 / p <1e-300 | 10.4 EB05 9.1 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.7 · ♀ 17% (drug 53%) · 93% clinician | no trial data cached |
| Ascites | 177 | 76.5 66.5–88.0ROR 85.5 · χ² 13,054 / p <1e-300 | 75.5 EB05 66.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.0 · ♀ 10% (drug 53%) · 97% clinician | no trial data cached |
| Appendicitis | 177 | 245.4 213.1–282.5ROR 274.5 · χ² 42,024 / p <1e-300 | 234.6 EB05 207.0 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 208.9 · ♀ 10% (drug 53%) · 97% clinician | no trial data cached |
| General physical health deterioration | 171 | 18.8 16.3–21.7ROR 20.9 · χ² 2,882 / p <1e-300 | 18.8 EB05 16.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 18.7 · ♀ 11% (drug 53%) · 96% clinician | no trial data cached |
| Cardiogenic shock | 170 | 152.4 132.0–175.9ROR 169.7 · χ² 25,127 / p <1e-300 | 148.1 EB05 130.3 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 128.7 · ♀ 11% (drug 53%) · 96% clinician | no trial data cached |
| Sepsis (blood infection) | 169 | 19.2 16.6–22.1ROR 21.2 · χ² 2,903 / p <1e-300 | 19.1 EB05 16.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.5 · ♀ 6% (drug 53%) · 95% clinician | no trial data cached |
| Condition aggravated | 165 | 6.9 6.0–8.0ROR 7.6 · χ² 840 / p 6e-185 | 6.8 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 · ♀ 17% (drug 53%) · 93% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 165 | 37.2 32.2–43.0ROR 41.2 · χ² 5,776 / p <1e-300 | 37.0 EB05 32.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.6 · ♀ 5% (drug 53%) · 96% clinician | no trial data cached |
| Ventricular fibrillation | 165 | 190.1 164.2–220.0ROR 211.0 · χ² 30,397 / p <1e-300 | 183.3 EB05 161.0 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 160.5 · ♀ 4% (drug 53%) · 96% clinician | no trial data cached |
| Stress | 164 | 28.9 25.0–33.4ROR 31.9 · χ² 4,392 / p <1e-300 | 28.7 EB05 25.2 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.4 · ♀ 6% (drug 53%) · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 162 | 73.8 63.7–85.5ROR 81.7 · χ² 11,509 / p <1e-300 | 72.8 EB05 63.8 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.7 · ♀ 6% (drug 53%) · 96% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Oseltamivir ↔ Neuropsychiatric events.
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 Oseltamivir Acid?
In FDA FAERS, the most frequently co-reported reaction terms for Oseltamivir Acid are vomiting, abdominal pain, abdominal distension, constipation, ascites, appendicitis. 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 Oseltamivir Acid have an FDA boxed warning?
No. The FDA label retrieved for Oseltamivir Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Oseltamivir Acid 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 7c0923ad-80b0-4134-b44a-754ea599f356, effective 20241209; matched on
openfda.generic_name.exact:"OSELTAMIVIR ACID" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 99 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.