Drug · FAERS side-effect profile with label screen
Osimertinib side effects: what 8,986 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
8,986 reports · 98% serious · 2,758 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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 3Lab value / disease marker 2No label text to screen 35
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. 1,001 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 |
|---|---|---|---|---|---|---|
| Egfr gene mutation | 152 | 445.9 362.8–548.1ROR 448.1 · χ² 39,718 / p <1e-300 | 256.1 EB05 223.7 · IC025 +6.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Acquired gene mutation | 473 | 369.5 330.2–413.4ROR 375.0 · χ² 110,497 / p <1e-300 | 233.5 EB05 216.4 · IC025 +7.4 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Braf v600e mutation positive | 20 | 350.5 203.4–603.7ROR 350.7 · χ² 4,300 / p <1e-300 | 187.3 EB05 128.1 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Drug resistance mutation | 47 | 239.9 171.7–335.3ROR 240.3 · χ² 7,989 / p <1e-300 | 163.8 EB05 128.2 · IC025 +5.5 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Malignant transformation | 116 | 230.0 186.2–284.2ROR 230.8 · χ² 19,355 / p <1e-300 | 165.4 EB05 141.7 · IC025 +6.3 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Non-small cell lung cancer recurrent | 43 | 120.7 87.2–167.1ROR 120.9 · χ² 4,203 / p <1e-300 | 97.6 EB05 75.5 · IC025 +5.1 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Braf gene mutation | 13 | 110.9 61.6–199.7ROR 110.9 · χ² 1,117 / p 4e-245 | 83.6 EB05 52.0 · IC025 +3.5 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Metastases to meninges | 307 | 104.4 92.6–117.8ROR 105.4 · χ² 27,001 / p <1e-300 | 89.6 EB05 81.5 · IC025 +6.1 3/3 methods agree | No label text to screen | – | NCT02474355: 1/3,014 (0.0%) on Osimertinib (serious AE) |
| Malignant neoplasm oligoprogression | 17 | 70.7 42.8–116.5ROR 70.7 · χ² 991 / p 9e-218 | 59.7 EB05 39.5 · IC025 +3.7 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Pericardial effusion malignant | 10 | 40.0 21.1–75.8ROR 40.0 · χ² 322 / p 2e-72 | 35.4 EB05 20.5 · IC025 +2.7 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Metastases to spinal cord | 11 | 39.4 21.4–72.4ROR 39.4 · χ² 353 / p 5e-79 | 35.1 EB05 20.9 · IC025 +2.8 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Paronychia | 225 | 36.1 31.5–41.2ROR 36.3 · χ² 7,233 / p <1e-300 | 34.1 EB05 30.5 · IC025 +4.8 3/3 methods agree | No label text to screen | – | NCT04487080: 61/213 (28.6%) on Osimertinib; 121/428 (28.3%) control |
| Lymphangiosis carcinomatosa | 54 | 35.9 27.3–47.2ROR 36.0 · χ² 1,704 / p <1e-300 | 33.7 EB05 26.8 · IC025 +4.3 3/3 methods agree | No label text to screen | – | NCT02474355: 1/3,014 (0.0%) on Osimertinib |
| Metastases to central nervous system | 658 | 35.6 32.9–38.5ROR 36.3 · χ² 20,955 / p <1e-300 | 33.8 EB05 31.7 · IC025 +4.9 3/3 methods agree | No label text to screen | – | NCT02474355: 1/3,014 (0.0%) on Osimertinib (serious AE) |
| Lung carcinoma cell type unspecified recurrent | 29 | 32.5 22.4–47.2ROR 32.6 · χ² 814 / p 2e-179 | 30.5 EB05 22.2 · IC025 +3.7 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Carcinoembryonic antigen increased | 90 | 32.1 26.0–39.7ROR 32.2 · χ² 2,557 / p <1e-300 | 30.5 EB05 25.6 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Metastases to adrenals | 40 | 29.9 21.8–41.1ROR 29.9 · χ² 1,041 / p 1e-228 | 28.3 EB05 21.7 · IC025 +3.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Non-small cell lung cancer metastatic | 37 | 29.5 21.3–41.1ROR 29.6 · χ² 949 / p 1e-208 | 27.9 EB05 21.2 · IC025 +3.8 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Drug resistance | 1,096 | 29.3 27.6–31.1ROR 30.3 · χ² 28,672 / p <1e-300 | 28.1 EB05 26.7 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Metastases to pleura | 44 | 29.0 21.4–39.2ROR 29.0 · χ² 1,112 / p 5e-244 | 27.5 EB05 21.3 · IC025 +3.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Lung adenocarcinoma stage iv | 16 | 28.9 17.5–47.7ROR 28.9 · χ² 386 / p 3e-86 | 26.9 EB05 17.5 · IC025 +3.1 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Non-small cell lung cancer stage iv | 14 | 26.5 15.6–45.3ROR 26.6 · χ² 306 / p 6e-69 | 24.7 EB05 15.5 · IC025 +2.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Small cell lung cancer | 56 | 26.2 20.1–34.2ROR 26.2 · χ² 1,280 / p 1e-280 | 25.0 EB05 20.0 · IC025 +3.9 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Thrombophlebitis migrans | 12 | 25.3 14.2–45.0ROR 25.3 · χ² 246 / p 9e-56 | 23.4 EB05 14.0 · IC025 +2.7 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Non-small cell lung cancer | 169 | 24.4 20.9–28.4ROR 24.5 · χ² 3,626 / p <1e-300 | 23.5 EB05 20.6 · IC025 +4.2 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Malignant pleural effusion | 56 | 22.6 17.3–29.5ROR 22.7 · χ² 1,098 / p 6e-241 | 21.8 EB05 17.4 · IC025 +3.8 3/3 methods agree | No label text to screen | – | NCT02474355: 2/3,014 (0.1%) on Osimertinib (serious AE) |
| Malignant neoplasm progression | 3,354 | 22.4 21.7–23.1ROR 24.9 · χ² 66,520 / p <1e-300 | 21.7 EB05 21.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Onychoclasis | 215 | 21.2 18.5–24.3ROR 21.4 · χ² 3,996 / p <1e-300 | 20.6 EB05 18.4 · IC025 +4.1 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Gene mutation | 62 | 21.2 16.4–27.3ROR 21.2 · χ² 1,134 / p 6e-249 | 20.4 EB05 16.5 · IC025 +3.7 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Onychalgia | 28 | 18.9 13.0–27.5ROR 18.9 · χ² 444 / p 6e-99 | 18.1 EB05 13.1 · IC025 +3.2 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Radiation pneumonitis | 52 | 16.3 12.4–21.5ROR 16.4 · χ² 715 / p 7e-158 | 15.8 EB05 12.5 · IC025 +3.3 3/3 methods agree | No label text to screen | – | NCT04487080: 1/428 (0.2%) control (serious AE) |
| Metastases to the mediastinum | 10 | 16.2 8.7–30.4ROR 16.2 · χ² 125 / p 3e-29 | 14.3 EB05 7.1 · IC025 +2.1 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Metastases to kidney | 13 | 15.8 9.1–27.4ROR 15.8 · χ² 162 / p 2e-37 | 14.4 EB05 8.1 · IC025 +2.4 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Nail disorder | 189 | 14.6 12.7–16.9ROR 14.7 · χ² 2,331 / p <1e-300 | 14.3 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen | – | NCT02474355: 2/3,014 (0.1%) on Osimertinib |
| Lung adenocarcinoma | 63 | 14.0 10.9–18.0ROR 14.0 · χ² 732 / p 2e-161 | 13.6 EB05 10.9 · IC025 +3.2 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Sars-cov-2 test negative | 14 | 13.7 8.1–23.3ROR 13.7 · χ² 150 / p 1e-34 | 12.3 EB05 7.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Hydrothorax | 16 | 12.8 7.8–21.1ROR 12.8 · χ² 160 / p 6e-37 | 11.5 EB05 6.9 · IC025 +2.4 3/3 methods agree | No label text to screen | – | NCT04487080: 1/421 (0.2%) on Osimertinib; 1/428 (0.2%) control (serious AE) |
| Myocardial injury | 19 | 12.8 8.1–20.2ROR 12.8 · χ² 191 / p 8e-44 | 11.7 EB05 7.4 · IC025 +2.5 3/3 methods agree | No label text to screen | – | NCT04487080: 1/213 (0.5%) control (serious AE) |
| Metastases to pelvis | 12 | 12.7 7.2–22.5ROR 12.7 · χ² 116 / p 2e-27 | 10.9 EB05 5.9 · IC025 +2.1 3/3 methods agree | No label text to screen | – | not reported in cached trials |
| Brain cancer metastatic | 13 | 12.6 7.3–21.7ROR 12.6 · χ² 125 / p 3e-29 | 10.9 EB05 6.1 · IC025 +2.2 3/3 methods agree | No label text to screen | – | 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 Osimertinib 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 (9 of 40 signal terms matched).
- NCT04487080 — A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic (N=1074, PHASE3; 328 AE terms posted; arms: Experimental: Arm A (Open-label): Amivan; Active Comparator: Arm B (Double-blind):; Experimental: Arm C (Double-blind): Laze)
- NCT02474355 — Real World Treatment Study of AZD9291 for Advanced/Metastatic EGFR T790M Mutation NSCLC (N=3017, PHASE3; 484 AE terms posted; arms: Osimertinib)
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 | 11,462 | 8.9 8.7–9.0ROR 13.3 · χ² 82,258 / p <1e-300 | 8.8 EB05 8.6 · IC025 +3.1 3/3 methods agree | Outcome field, not a reaction | – | NCT04487080: 1/213 (0.5%) on Osimertinib; 1/428 (0.2%) control (serious AE) |
| Malignant neoplasm progression | 3,354 | 22.4 21.7–23.1ROR 24.9 · χ² 66,520 / p <1e-300 | 21.7 EB05 21.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Diarrhoea (diarrhea) | 1,677 | 1.7 1.6–1.8ROR 1.8 · χ² 517 / p 1e-114 | 1.7 EB05 1.6 · IC025 +0.7 | No label text to screen | – | NCT04487080: 1/213 (0.5%) on Osimertinib; 2/428 (0.5%) control (serious AE) |
| Drug resistance | 1,096 | 29.3 27.6–31.1ROR 30.3 · χ² 28,672 / p <1e-300 | 28.1 EB05 26.7 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Fatigue (tiredness) | 1,037 | 0.9 0.8–0.9ROR 0.9 · χ² 18 / p 1e-5 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | No label text to screen | – | NCT04487080: 1/213 (0.5%) on Osimertinib; 2/428 (0.5%) control (serious AE) |
| Rash | 936 | 1.4 1.3–1.5ROR 1.4 · χ² 119 / p 6e-28 | 1.4 EB05 1.3 · IC025 +0.4 | No label text to screen | – | NCT04487080: 7/421 (1.7%) on Osimertinib (serious AE) |
| Off label use (used outside approved label) | 797 | 0.6 0.6–0.6ROR 0.6 · χ² 215 / p 5e-49 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | – | not reported in cached trials |
| Decreased appetite (loss of appetite) | 795 | 2.3 2.1–2.4ROR 2.3 · χ² 563 / p 7e-125 | 2.3 EB05 2.1 · IC025 +1.1 3/3 methods agree | No label text to screen | – | NCT04487080: 2/421 (0.5%) on Osimertinib (serious AE) |
| Disease progression | 762 | 4.3 4.0–4.6ROR 4.4 · χ² 1,906 / p <1e-300 | 4.2 EB05 4.0 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Dyspnoea (shortness of breath) | 752 | 0.9 0.8–0.9ROR 0.9 · χ² 14 / p 1e-4 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | No label text to screen | – | NCT04487080: 2/213 (0.9%) on Osimertinib; 11/428 (2.6%) control (serious AE) |
| Drug ineffective (drug did not work) | 738 | 0.4 0.3–0.4ROR 0.4 · χ² 851 / p 2e-187 | 0.4 EB05 0.3 · IC025 -1.6 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | – | not reported in cached trials |
| Nausea | 717 | 0.6 0.6–0.6ROR 0.6 · χ² 201 / p 6e-46 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | No label text to screen | – | NCT04487080: 2/421 (0.5%) on Osimertinib; 1/213 (0.5%) control (serious AE) |
| Metastases to central nervous system | 658 | 35.6 32.9–38.5ROR 36.3 · χ² 20,955 / p <1e-300 | 33.8 EB05 31.7 · IC025 +4.9 3/3 methods agree | No label text to screen | – | NCT02474355: 1/3,014 (0.0%) on Osimertinib (serious AE) |
| Asthenia (weakness) | 645 | 1.1 1.0–1.2ROR 1.1 · χ² 10 / p 0.001 | 1.1 EB05 1.1 · IC025 +0.0 | No label text to screen | – | NCT04487080: 1/213 (0.5%) on Osimertinib; 1/428 (0.2%) control (serious AE) |
| Interstitial lung disease | 591 | 8.1 7.5–8.8ROR 8.3 · χ² 3,655 / p <1e-300 | 8.0 EB05 7.5 · IC025 +2.9 3/3 methods agree | No label text to screen | – | NCT04487080: 3/213 (1.4%) on Osimertinib; 5/428 (1.2%) control (serious AE) |
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.
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 Osimertinib?
In FDA FAERS, the most frequently co-reported reaction terms for Osimertinib are diarrhoea, fatigue, rash, decreased appetite, dyspnoea, nausea. 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 Osimertinib have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Osimertinib 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 1,041 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
OSIMERTINIB, 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.