Drug · FAERS side-effect profile with label screen
Oseltamivir side effects: what 7,914 FDA adverse event reports show
Drug class
Influenza neuraminidase inhibitor (nai)
FDA label, Indications wording
Who reports
7,914 reports · 75% serious · 1,216 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Oseltamivir phosphate capsule is an influenza neuraminidase inhibitor (NAI) indicated for: Treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours. ( 1.1 ) Prophylaxis of influenza A and B in patients 1 year and older. ( 1.2 ) Limitations of Use : Not a substitute for annual influenza vaccination.
FDA label, Indications and Usage
What it is
Oseltamivir phosphate capsules, USP, an influenza neuraminidase inhibitor (NAI), are available as capsules containing 30 mg, 45 mg, or 75 mg of oseltamivir for oral use, in the form of oseltamivir phosphate, USP.
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 (related wording) 1Likely indication confounding 3Reporting / coding artifact 7Lab value / disease marker 4Not in label — unassessed 25
What the badges mean
- 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. 959 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 |
|---|---|---|---|---|---|---|
| Antacid therapy | 75 | 4,454.0 3,071.8–6,458.2ROR 4,496.6 · χ² 121,819 / p <1e-300 | 1,156.7 EB05 953.2 · IC025 +6.7 3/3 methods agree | Reporting / coding artifact | serious n=75 · ♀ 24% (drug 52%) · 99% clinician | no trial data cached |
| Sleep disorder therapy | 107 | 3,631.1 2,711.4–4,862.8ROR 3,680.8 · χ² 160,986 / p <1e-300 | 1,192.8 EB05 1,014.8 · IC025 +7.2 3/3 methods agree | Reporting / coding artifact | serious n=107 · ♀ 6% (drug 52%) · 97% clinician | no trial data cached |
| Appendicolith | 214 | 3,473.2 2,834.3–4,256.2ROR 3,569.7 · χ² 317,443 / p <1e-300 | 1,314.7 EB05 1,173.3 · IC025 +8.2 3/3 methods agree | Not in label — unassessed | serious n=214 · ♀ 8% (drug 52%) · 96% clinician | no trial data cached |
| Analgesic therapy | 119 | 1,690.0 1,343.4–2,125.9ROR 1,715.7 · χ² 120,956 / p <1e-300 | 880.1 EB05 755.2 · IC025 +7.3 3/3 methods agree | Reporting / coding artifact | serious n=119 · ♀ 15% (drug 52%) · 96% clinician | no trial data cached |
| Drug therapy | 114 | 1,474.7 1,173.4–1,853.3ROR 1,496.2 · χ² 106,381 / p <1e-300 | 813.3 EB05 695.5 · IC025 +7.2 3/3 methods agree | Reporting / coding artifact | serious n=114 · ♀ 16% (drug 52%) · 96% clinician | no trial data cached |
| Anticoagulant therapy | 73 | 949.0 726.7–1,239.4ROR 957.8 · χ² 50,021 / p <1e-300 | 588.4 EB05 483.5 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=73 · ♀ 24% (drug 52%) · 97% clinician | no trial data cached |
| Malignant melanoma stage 0 | 42 | 801.1 567.3–1,131.1ROR 805.3 · χ² 25,078 / p <1e-300 | 478.9 EB05 369.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 0% (drug 52%) · 100% clinician | no trial data cached |
| Congenital hiatus hernia | 49 | 753.2 548.5–1,034.1ROR 757.9 · χ² 27,991 / p <1e-300 | 475.7 EB05 374.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 0% (drug 52%) · 100% clinician | no trial data cached |
| Bacteroides infection | 35 | 413.8 289.9–590.7ROR 415.7 · χ² 12,090 / p <1e-300 | 299.0 EB05 224.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=35 · ♀ 0% (drug 52%) · 94% clinician | no trial data cached |
| Hepatitis infectious mononucleosis | 12 | 373.3 204.0–683.2ROR 373.9 · χ² 3,580 / p <1e-300 | 215.3 EB05 131.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Purpura senile | 10 | 241.9 126.6–462.3ROR 242.3 · χ² 1,981 / p <1e-300 | 156.2 EB05 90.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hyperphosphataemia | 147 | 197.5 167.2–233.2ROR 201.2 · χ² 26,539 / p <1e-300 | 179.4 EB05 156.4 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=147 · ♀ 13% (drug 52%) · 97% clinician | no trial data cached |
| Blood phosphorus increased | 178 | 185.2 159.3–215.2ROR 189.4 · χ² 30,278 / p <1e-300 | 169.8 EB05 149.9 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=178 · ♀ 10% (drug 52%) · 96% clinician | no trial data cached |
| Bronchopulmonary aspergillosis allergic | 43 | 130.3 96.0–176.9ROR 131.1 · χ² 5,135 / p <1e-300 | 117.8 EB05 91.1 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 5% (drug 52%) · 100% clinician | no trial data cached |
| Influenza a virus test positive | 15 | 95.1 56.9–159.2ROR 95.3 · χ² 1,259 / p 5e-276 | 82.5 EB05 53.1 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=15 | no trial data cached |
| Urinary tract inflammation | 12 | 92.0 51.7–163.5ROR 92.1 · χ² 957 / p 2e-210 | 78.2 EB05 47.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Normal newborn | 161 | 80.9 69.2–94.5ROR 82.5 · χ² 12,245 / p <1e-300 | 77.8 EB05 68.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | no trial data cached |
| H1n1 influenza | 40 | 77.1 56.3–105.5ROR 77.5 · χ² 2,844 / p <1e-300 | 72.4 EB05 55.5 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=40 · 92% clinician | no trial data cached |
| Blood uric acid increased | 142 | 66.8 56.7–78.8ROR 68.0 · χ² 8,919 / p <1e-300 | 64.7 EB05 56.2 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=142 · ♀ 13% (drug 52%) · 97% clinician | no trial data cached |
| Total lung capacity decreased | 39 | 66.1 48.1–90.7ROR 66.4 · χ² 2,375 / p <1e-300 | 62.6 EB05 47.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=39 · ♀ 18% (drug 52%) · 95% clinician | no trial data cached |
| Appendicitis | 222 | 64.8 56.8–73.9ROR 66.6 · χ² 13,551 / p <1e-300 | 62.9 EB05 56.3 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 49.3 · ♀ 10% (drug 52%) · 96% clinician | no trial data cached |
| Iron deficiency | 103 | 62.8 51.7–76.3ROR 63.6 · χ² 6,058 / p <1e-300 | 60.7 EB05 51.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=103 · ♀ 7% (drug 52%) · 95% clinician | no trial data cached |
| Jc virus infection | 35 | 59.3 42.5–82.9ROR 59.6 · χ² 1,905 / p <1e-300 | 56.3 EB05 42.3 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=35 · ♀ 0% (drug 52%) · 94% clinician | no trial data cached |
| Product ineffective for unapproved use | 30 | 58.1 40.5–83.3ROR 58.3 · χ² 1,591 / p <1e-300 | 55.0 EB05 40.3 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=30 · ♀ 100% (drug 52%) | no trial data cached |
| Activated partial thromboplastin time prolonged | 106 | 56.4 46.6–68.3ROR 57.2 · χ² 5,596 / p <1e-300 | 54.7 EB05 46.5 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=106 · ♀ 17% (drug 52%) · 96% clinician | no trial data cached |
| Neuropsychological symptoms | 12 | 56.0 31.6–99.2ROR 56.1 · χ² 582 / p 7e-129 | 50.7 EB05 30.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Myasthenia gravis | 163 | 56.0 48.0–65.3ROR 57.1 · χ² 8,566 / p <1e-300 | 54.5 EB05 47.8 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 43.0 · ♀ 8% (drug 52%) · 97% clinician | no trial data cached |
| Aortic stenosis | 69 | 53.5 42.2–67.9ROR 54.0 · χ² 3,434 / p <1e-300 | 51.8 EB05 42.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=69 · ♀ 27% (drug 52%) · 94% clinician | no trial data cached |
| Hypophosphataemia | 143 | 52.6 44.6–62.0ROR 53.5 · χ² 7,044 / p <1e-300 | 51.2 EB05 44.6 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 41.4 · ♀ 7% (drug 52%) · 97% clinician | no trial data cached |
| Ventricular fibrillation | 208 | 50.4 44.0–57.7ROR 51.7 · χ² 9,838 / p <1e-300 | 49.3 EB05 43.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 38.1 · ♀ 5% (drug 52%) · 96% clinician | no trial data cached |
| Pleuritic pain | 47 | 45.7 34.2–60.9ROR 45.9 · χ² 1,974 / p <1e-300 | 44.1 EB05 34.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=47 · ♀ 20% (drug 52%) · 100% clinician | no trial data cached |
| Lung opacity | 43 | 45.0 33.3–60.8ROR 45.2 · χ² 1,775 / p <1e-300 | 43.4 EB05 33.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 24% (drug 52%) · 90% clinician | no trial data cached |
| Cardiogenic shock | 219 | 41.3 36.2–47.1ROR 42.4 · χ² 8,439 / p <1e-300 | 40.5 EB05 36.2 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 31.2 · ♀ 10% (drug 52%) · 96% clinician | no trial data cached |
| Glomerulonephritis minimal lesion | 11 | 40.8 22.5–73.9ROR 40.8 · χ² 382 / p 2e-85 | 37.8 EB05 22.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Idiosyncratic drug reaction | 14 | 38.2 22.5–64.7ROR 38.3 · χ² 464 / p 4e-103 | 36.0 EB05 22.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Pyloric stenosis | 12 | 37.9 21.4–66.9ROR 37.9 · χ² 389 / p 7e-87 | 35.4 EB05 21.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Excessive eye blinking | 20 | 36.3 23.4–56.4ROR 36.4 · χ² 643 / p 3e-142 | 34.8 EB05 23.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=20 · 95% clinician | no trial data cached |
| Pneumonia influenzal | 16 | 35.9 21.9–58.8ROR 36.0 · χ² 502 / p 2e-111 | 34.1 EB05 22.3 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Pathogen resistance | 121 | 35.7 29.9–42.6ROR 36.2 · χ² 3,991 / p <1e-300 | 35.0 EB05 30.1 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 28.5 · 97% clinician | no trial data cached |
| Respiratory symptom | 36 | 34.5 24.8–47.9ROR 34.6 · χ² 1,122 / p 3e-246 | 33.5 EB05 25.3 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=36 · ♀ 0% (drug 52%) · 100% 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) | 1,864 | 5.7 5.5–5.9ROR 7.1 · χ² 7,514 / p <1e-300 | 5.7 EB05 5.5 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 5.6 · 95% clinician | no trial data cached |
| Drug ineffective (drug did not work) | 800 | 1.6 1.5–1.7ROR 1.7 · χ² 196 / p 6e-45 | 1.6 EB05 1.5 · IC025 +0.6 | Reporting / coding artifact | serious PRR 3.3 · 91% clinician | no trial data cached |
| No adverse event | 585 | 8.8 8.1–9.5ROR 9.4 · χ² 4,036 / p <1e-300 | 8.7 EB05 8.1 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.1 · 97% clinician | no trial data cached |
| Vomiting | 485 | 2.7 2.5–3.0ROR 2.9 · χ² 547 / p 3e-121 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Nausea | 483 | 1.6 1.5–1.8ROR 1.7 · χ² 119 / p 5e-28 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Headache | 432 | 1.8 1.7–2.0ROR 1.9 · χ² 166 / p 3e-38 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.5 · ♀ 79% (drug 52%) | no trial data cached |
| Drug intolerance | 408 | 11.3 10.3–12.4ROR 11.8 · χ² 3,810 / p <1e-300 | 11.2 EB05 10.3 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 13.8 | no trial data cached |
| Pneumonia (lung infection) | 389 | 3.2 2.9–3.5ROR 3.3 · χ² 591 / p 7e-131 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.5 | no trial data cached |
| Condition aggravated | 383 | 3.4 3.0–3.7ROR 3.5 · χ² 642 / p 6e-142 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.8 · ♀ 30% (drug 52%) · 94% clinician | no trial data cached |
| Product use in unapproved indication | 351 | 3.8 3.4–4.2ROR 3.9 · χ² 732 / p 2e-161 | 3.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 | no trial data cached |
| Influenza | 343 | 8.1 7.3–9.0ROR 8.5 · χ² 2,148 / p <1e-300 | 8.1 EB05 7.4 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.8 | no trial data cached |
| Abdominal pain | 317 | 3.6 3.2–4.0ROR 3.7 · χ² 603 / p 2e-133 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · ♀ 31% (drug 52%) | no trial data cached |
| Dyspnoea (shortness of breath) | 315 | 1.5 1.3–1.6ROR 1.5 · χ² 49 / p 1e-12 | 1.5 EB05 1.3 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Sepsis (blood infection) | 296 | 7.0 6.3–7.9ROR 7.3 · χ² 1,533 / p <1e-300 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · ♀ 13% (drug 52%) · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 281 | 26.9 24.0–30.2ROR 27.9 · χ² 6,930 / p <1e-300 | 26.6 EB05 24.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 · ♀ 8% (drug 52%) · 96% 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.
- Appendicolith — n=214, PRR 3,473.2
- Malignant melanoma stage 0 — n=42, PRR 801.1
- Congenital hiatus hernia — n=49, PRR 753.2
- Bacteroides infection — n=35, PRR 413.8
- Hyperphosphataemia — n=147, PRR 197.5
- Bronchopulmonary aspergillosis allergic — n=43, PRR 130.3
- Normal newborn — n=161, PRR 80.9
- Total lung capacity decreased — n=39, PRR 66.1
- Appendicitis — n=222, PRR 64.8
- Iron deficiency — n=103, PRR 62.8
✓ 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?
In FDA FAERS, the most frequently co-reported reaction terms for Oseltamivir are vomiting, nausea, headache, pneumonia, influenza, abdominal pain. 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 have an FDA boxed warning?
No. The FDA label retrieved for Oseltamivir has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Oseltamivir 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 82685c2f-791b-440f-a1c2-5a032da7adca, effective 20250730; matched on
openfda.generic_name.exact:"OSELTAMIVIR") - 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, 999 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.