Drug · FAERS side-effect profile with label screen
Afatinib side effects: what 6,586 FDA adverse event reports show
Drug class
Not stated in label
Who reports
6,586 reports · 87% serious · 1,464 with death outcome · 62% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Afatinib tablets are a kinase inhibitor indicated for: • First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approve.
FDA label, Indications and Usage
What it is
Afatinib tablets contain afatinib, a tyrosine kinase inhibitor which is a 4-anilinoquinazoline. Afatinib is presented as the dimaleate salt, with the chemical name 2-butenamide, N-[4-[(3-chloro-4-fluorophenyl)amino]-7-[[(3S)-tetrahydro-3-furanyl]oxy]-6-quinazolinyl]-4-(dimethylamino)-,(2E)-,(2Z)-2-butenedioate(1:2).
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 18Labeled (related wording) 4Reporting / coding artifact 4Not in label — unassessed 14
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.
- 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.
- 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. 182 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 |
|---|---|---|---|---|---|---|
| Metastases to central nervous system | 270 | 68.5 60.9–77.1ROR 71.4 · χ² 17,529 / p <1e-300 | 66.8 EB05 60.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 45.1 | no trial data cached |
| Malignant neoplasm progression | 1,691 | 53.7 51.5–56.0ROR 71.9 · χ² 86,407 / p <1e-300 | 52.8 EB05 50.7 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 35.9 | no trial data cached |
| Stomatitis (mouth sores) | 485 | 25.6 23.5–28.0ROR 27.6 · χ² 11,404 / p <1e-300 | 25.4 EB05 23.6 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.5 | no trial data cached |
| Metastases to bone | 90 | 17.6 14.3–21.6ROR 17.8 · χ² 1,386 / p <1e-300 | 17.4 EB05 14.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Drug resistance | 141 | 17.6 14.9–20.7ROR 17.9 · χ² 2,177 / p <1e-300 | 17.4 EB05 15.1 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 12.3 · 95% clinician | no trial data cached |
| Therapy partial responder | 79 | 16.8 13.5–20.9ROR 17.0 · χ² 1,151 / p 1e-252 | 16.6 EB05 13.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 13.5 · 100% clinician | no trial data cached |
| Metastases to lung | 57 | 15.8 12.2–20.5ROR 15.9 · χ² 772 / p 4e-170 | 15.6 EB05 12.4 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.5 | no trial data cached |
| Mucosal inflammation | 117 | 14.4 12.0–17.2ROR 14.6 · χ² 1,435 / p <1e-300 | 14.2 EB05 12.2 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 | no trial data cached |
| Metastases to liver | 77 | 14.0 11.2–17.5ROR 14.2 · χ² 916 / p 2e-201 | 13.9 EB05 11.4 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.4 | no trial data cached |
| Skin fissures | 71 | 12.0 9.5–15.1ROR 12.1 · χ² 704 / p 2e-155 | 11.8 EB05 9.6 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=65 | no trial data cached |
| Oral pain | 78 | 11.1 8.9–13.8ROR 11.2 · χ² 704 / p 2e-155 | 10.8 EB05 8.9 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.9 · ♀ 85% (drug 62%) | no trial data cached |
| Diarrhoea (diarrhea) | 2,121 | 10.5 10.2–10.9ROR 15.1 · χ² 18,798 / p <1e-300 | 10.5 EB05 10.1 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.6 | no trial data cached |
| Interstitial lung disease | 149 | 9.8 8.4–11.5ROR 10.0 · χ² 1,174 / p 1e-257 | 9.7 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · 95% clinician | no trial data cached |
| Pneumonitis | 81 | 9.6 7.7–11.9ROR 9.7 · χ² 611 / p 3e-135 | 9.3 EB05 7.7 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Pleural effusion | 181 | 9.5 8.2–11.0ROR 9.7 · χ² 1,365 / p 4e-299 | 9.3 EB05 8.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Skin disorder | 88 | 8.4 6.9–10.4ROR 8.5 · χ² 569 / p 5e-126 | 8.2 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Pulmonary mass | 36 | 7.7 5.6–10.7ROR 7.8 · χ² 204 / p 2e-46 | 7.2 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Dehydration | 316 | 7.6 6.8–8.4ROR 7.9 · χ² 1,798 / p <1e-300 | 7.5 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Mouth ulceration | 49 | 7.4 5.6–9.8ROR 7.5 · χ² 266 / p 4e-60 | 7.0 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.9 | no trial data cached |
| Electrolyte imbalance | 26 | 7.2 4.9–10.6ROR 7.2 · χ² 133 / p 5e-31 | 6.5 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 · ♀ 84% (drug 62%) | no trial data cached |
| Acne | 168 | 7.0 6.1–8.2ROR 7.2 · χ² 865 / p 2e-190 | 6.9 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.1 | no trial data cached |
| Rash | 884 | 6.5 6.1–6.9ROR 7.4 · χ² 4,188 / p <1e-300 | 6.5 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Central nervous system lesion | 28 | 6.5 4.5–9.3ROR 6.5 · χ² 124 / p 5e-29 | 5.9 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Neoplasm progression | 70 | 6.4 5.0–8.0ROR 6.4 · χ² 311 / p 8e-70 | 6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Decreased appetite (loss of appetite) | 450 | 6.2 5.7–6.8ROR 6.6 · χ² 1,973 / p <1e-300 | 6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Neoplasm | 22 | 6.1 4.0–9.2ROR 6.1 · χ² 88 / p 3e-21 | 5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Epistaxis (nosebleed) | 139 | 5.9 5.0–7.0ROR 6.0 · χ² 563 / p 8e-125 | 5.8 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Feeding disorder | 36 | 5.8 4.2–8.0ROR 5.8 · χ² 137 / p 7e-32 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Disease progression | 205 | 5.5 4.8–6.3ROR 5.7 · χ² 761 / p 6e-168 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 91% clinician | no trial data cached |
| Skin reaction | 24 | 5.4 3.6–8.1ROR 5.5 · χ² 82 / p 5e-20 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 38 | 5.4 3.9–7.4ROR 5.4 · χ² 132 / p 6e-31 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 · ♀ 84% (drug 62%) | no trial data cached |
| Scab | 19 | 5.3 3.4–8.4ROR 5.4 · χ² 63 / p 1e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Dermatitis | 33 | 5.1 3.6–7.1ROR 5.1 · χ² 104 / p 1e-24 | 4.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Pneumothorax | 25 | 5.0 3.4–7.4ROR 5.0 · χ² 77 / p 1e-18 | 4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Folliculitis | 16 | 4.9 3.0–8.1ROR 4.9 · χ² 46 / p 5e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Ileus | 19 | 4.9 3.1–7.7ROR 4.9 · χ² 55 / p 5e-14 | 4.4 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Dry skin | 199 | 4.8 4.2–5.5ROR 4.9 · χ² 602 / p 3e-133 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 | no trial data cached |
| Palmar-plantar erythrodysaesthesia syndrome | 35 | 4.8 3.4–6.6ROR 4.8 · χ² 100 / p 6e-24 | 4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 91% clinician | no trial data cached |
| Hair texture abnormal | 20 | 4.7 3.0–7.3ROR 4.7 · χ² 55 / p 6e-14 | 4.3 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=14 · 80% consumer | no trial data cached |
| Conjunctivitis | 27 | 4.7 3.2–6.8ROR 4.7 · χ² 75 / p 3e-18 | 4.4 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | 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) | 2,121 | 10.5 10.2–10.9ROR 15.1 · χ² 18,798 / p <1e-300 | 10.5 EB05 10.1 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.6 | no trial data cached |
| Malignant neoplasm progression | 1,691 | 53.7 51.5–56.0ROR 71.9 · χ² 86,407 / p <1e-300 | 52.8 EB05 50.7 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 35.9 | no trial data cached |
| Rash | 884 | 6.5 6.1–6.9ROR 7.4 · χ² 4,188 / p <1e-300 | 6.5 EB05 6.1 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Death | 518 | 1.9 1.8–2.1ROR 2.0 · χ² 235 / p 2e-53 | 1.9 EB05 1.8 · IC025 +0.8 | Outcome field, not a reaction | serious PRR 1.3 | no trial data cached |
| Nausea | 486 | 2.0 1.8–2.1ROR 2.0 · χ² 237 / p 9e-54 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Stomatitis (mouth sores) | 485 | 25.6 23.5–28.0ROR 27.6 · χ² 11,404 / p <1e-300 | 25.4 EB05 23.6 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.5 | no trial data cached |
| Decreased appetite (loss of appetite) | 450 | 6.2 5.7–6.8ROR 6.6 · χ² 1,973 / p <1e-300 | 6.1 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Vomiting | 407 | 2.8 2.5–3.0ROR 2.9 · χ² 467 / p 8e-104 | 2.8 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Dehydration | 316 | 7.6 6.8–8.4ROR 7.9 · χ² 1,798 / p <1e-300 | 7.5 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Metastases to central nervous system | 270 | 68.5 60.9–77.1ROR 71.4 · χ² 17,529 / p <1e-300 | 66.8 EB05 60.4 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 45.1 | no trial data cached |
| Asthenia (weakness) | 237 | 2.0 1.8–2.3ROR 2.0 · χ² 121 / p 2e-28 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Weight decreased (weight loss) | 207 | 2.4 2.1–2.7ROR 2.4 · χ² 163 / p 1e-37 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Disease progression | 205 | 5.5 4.8–6.3ROR 5.7 · χ² 761 / p 6e-168 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 91% clinician | no trial data cached |
| Dry skin | 199 | 4.8 4.2–5.5ROR 4.9 · χ² 602 / p 3e-133 | 4.8 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 | no trial data cached |
| Pneumonia (lung infection) | 191 | 1.9 1.6–2.2ROR 1.9 · χ² 79 / p 3e-19 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.3 | 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.
- Metastases to central nervous system — n=270, PRR 68.5
- Metastases to bone — n=90, PRR 17.6
- Pleural effusion — n=181, PRR 9.5
- Pulmonary mass — n=36, PRR 7.7
- Electrolyte imbalance — n=26, PRR 7.2
- Central nervous system lesion — n=28, PRR 6.5
- Neoplasm progression — n=70, PRR 6.4
- Neoplasm — n=22, PRR 6.1
- Feeding disorder — n=36, PRR 5.8
- Pneumothorax — n=25, PRR 5.0
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 Afatinib?
In FDA FAERS, the most frequently co-reported reaction terms for Afatinib are diarrhoea, rash, nausea, stomatitis, decreased appetite, vomiting. 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 Afatinib have an FDA boxed warning?
No. The FDA label retrieved for Afatinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Afatinib 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 ec5b9e00-3eab-4dbd-9bb3-75865b1af485, effective 20260903; matched on
openfda.generic_name.exact:"AFATINIB") - 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, 222 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.