Drug · FAERS side-effect profile with label screen
Erlotinib side effects: what 9,629 FDA adverse event reports show
Drug class
Not stated in label
Who reports
9,629 reports · 98% serious · 4,329 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Erlotinib tablets are a kinase inhibitor indicated for: The treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations a.
FDA label, Indications and Usage
What it is
Erlotinib Tablets, a kinase inhibitor, is a quinazolinamine with the chemical name N-(3-ethynylphenyl)-6,7-bis(2-methoxyethoxy)-4-quinazolinamine. Erlotinib Tablets contain erlotinib as the hydrochloride salt that has the following structural formula: C 22 H 23 N 3 O 4 •HCl M.W.
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 2Labeled (related wording) 6Likely indication confounding 6Reporting / coding artifact 3Not in label — unassessed 23
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.
- 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.
- 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. 962 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 |
|---|---|---|---|---|---|---|
| Erythema dyschromicum perstans | 21 | 1,409.3 813.1–2,442.9ROR 1,412.4 · χ² 17,003 / p <1e-300 | 478.5 EB05 330.2 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=12 · 100% clinician | no trial data cached |
| Egfr gene mutation | 58 | 395.4 299.1–522.8ROR 397.8 · χ² 18,939 / p <1e-300 | 300.9 EB05 241.4 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=58 | no trial data cached |
| Malignant transformation | 23 | 117.6 77.3–178.9ROR 117.9 · χ² 2,412 / p <1e-300 | 102.3 EB05 71.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 90% (drug 51%) · 100% clinician | no trial data cached |
| Metastases to thorax | 11 | 98.4 53.8–180.1ROR 98.5 · χ² 923 / p 4e-203 | 81.3 EB05 48.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Acquired gene mutation | 56 | 96.4 73.8–126.0ROR 97.0 · χ² 4,971 / p <1e-300 | 89.6 EB05 71.6 · IC025 +5.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=55 · 93% clinician | no trial data cached |
| Lung adenocarcinoma stage iv | 15 | 89.5 53.4–149.9ROR 89.6 · χ² 1,176 / p 4e-258 | 77.7 EB05 50.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Trichiasis | 11 | 80.4 44.0–146.6ROR 80.4 · χ² 756 / p 9e-167 | 68.7 EB05 40.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Growth of eyelashes | 26 | 73.5 49.7–108.6ROR 73.7 · χ² 1,728 / p <1e-300 | 67.7 EB05 48.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Dermatitis acneiform | 188 | 69.8 60.4–80.6ROR 71.2 · χ² 12,285 / p <1e-300 | 67.2 EB05 59.5 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=179 | no trial data cached |
| Non-small cell lung cancer stage iv | 10 | 62.1 33.1–116.4ROR 62.1 · χ² 526 / p 1e-116 | 54.4 EB05 31.6 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Paronychia | 113 | 58.4 48.5–70.3ROR 59.0 · χ² 6,148 / p <1e-300 | 56.3 EB05 48.1 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=110 | no trial data cached |
| Hepatobiliary disease | 12 | 42.2 23.9–74.8ROR 42.3 · χ² 434 / p 9e-97 | 39.1 EB05 23.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Drug resistance | 466 | 40.2 36.8–44.0ROR 42.2 · χ² 17,477 / p <1e-300 | 39.4 EB05 36.5 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 26.1 | no trial data cached |
| Non-small cell lung cancer | 82 | 38.4 30.9–47.7ROR 38.7 · χ² 2,898 / p <1e-300 | 37.4 EB05 31.1 · IC025 +4.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=82 | no trial data cached |
| Xerosis | 21 | 38.0 24.7–58.5ROR 38.1 · χ² 707 / p 4e-156 | 36.2 EB05 25.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Metastases to meninges | 38 | 37.5 27.2–51.7ROR 37.7 · χ² 1,292 / p 3e-283 | 36.3 EB05 27.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=38 | no trial data cached |
| Non-small cell lung cancer metastatic | 14 | 36.0 21.2–61.0ROR 36.1 · χ² 435 / p 7e-97 | 33.9 EB05 21.5 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=14 | no trial data cached |
| Lung adenocarcinoma | 46 | 33.7 25.2–45.0ROR 33.8 · χ² 1,403 / p <1e-300 | 32.8 EB05 25.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=46 | no trial data cached |
| Metastases to pleura | 14 | 29.7 17.5–50.2ROR 29.7 · χ² 355 / p 2e-79 | 28.2 EB05 17.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Skin toxicity | 69 | 27.3 21.5–34.5ROR 27.4 · χ² 1,698 / p <1e-300 | 26.8 EB05 21.9 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=67 | no trial data cached |
| Multiple-drug resistance | 37 | 26.3 19.1–36.4ROR 26.4 · χ² 866 / p 1e-190 | 25.7 EB05 19.5 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious n=37 · ♀ 74% (drug 51%) · 95% clinician | no trial data cached |
| Malignant pleural effusion | 20 | 26.2 16.8–40.7ROR 26.2 · χ² 454 / p 5e-101 | 25.3 EB05 17.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Gene mutation | 23 | 25.5 16.9–38.4ROR 25.5 · χ² 511 / p 2e-113 | 24.7 EB05 17.3 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · 100% clinician | no trial data cached |
| Gastrointestinal toxicity | 52 | 24.3 18.5–31.9ROR 24.4 · χ² 1,126 / p 3e-247 | 23.9 EB05 18.9 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=51 | no trial data cached |
| Lung cancer metastatic | 31 | 23.7 16.7–33.8ROR 23.8 · χ² 645 / p 2e-142 | 23.2 EB05 17.1 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=31 · 87% consumer | no trial data cached |
| Small cell lung cancer | 15 | 22.6 13.6–37.5ROR 22.6 · χ² 285 / p 3e-64 | 21.7 EB05 13.8 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=15 | no trial data cached |
| Pneumoperitoneum | 18 | 21.6 13.6–34.4ROR 21.7 · χ² 330 / p 4e-74 | 20.9 EB05 13.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Metastases to spine | 32 | 21.0 14.8–29.7ROR 21.0 · χ² 583 / p 3e-129 | 20.5 EB05 15.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=32 · 81% consumer | no trial data cached |
| Adenocarcinoma | 21 | 20.5 13.4–31.5ROR 20.6 · χ² 367 / p 4e-82 | 19.9 EB05 13.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Metastasis | 61 | 18.7 14.5–24.0ROR 18.8 · χ² 994 / p 2e-218 | 18.4 EB05 14.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 · 73% consumer | no trial data cached |
| Pneumatosis intestinalis | 24 | 18.6 12.4–27.7ROR 18.6 · χ² 378 / p 2e-84 | 18.1 EB05 12.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Rash pustular | 60 | 18.0 14.0–23.2ROR 18.1 · χ² 938 / p 3e-206 | 17.7 EB05 14.3 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=57 | no trial data cached |
| Haematotoxicity | 75 | 17.7 14.2–22.3ROR 17.9 · χ² 1,160 / p 2e-254 | 17.5 EB05 14.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 · 83% consumer | no trial data cached |
| Metastases to central nervous system | 102 | 17.5 14.4–21.2ROR 17.6 · χ² 1,555 / p <1e-300 | 17.3 EB05 14.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Radiation pneumonitis | 17 | 17.4 10.8–28.0ROR 17.4 · χ² 245 / p 2e-55 | 16.7 EB05 10.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Histoplasmosis disseminated | 12 | 16.9 9.6–29.8ROR 16.9 · χ² 163 / p 2e-37 | 15.7 EB05 8.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Malignant neoplasm progression | 767 | 16.5 15.4–17.7ROR 17.9 · χ² 11,131 / p <1e-300 | 16.4 EB05 15.4 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 | no trial data cached |
| Pancreatic carcinoma metastatic | 20 | 15.3 9.9–23.8ROR 15.4 · χ² 252 / p 4e-57 | 14.7 EB05 9.6 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | no trial data cached |
| Ulcerative keratitis | 19 | 15.3 9.7–23.9ROR 15.3 · χ² 237 / p 7e-54 | 14.6 EB05 9.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Embolism | 57 | 14.9 11.5–19.4ROR 15.0 · χ² 723 / p 1e-159 | 14.7 EB05 11.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | 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 |
|---|---|---|---|---|---|---|
| Death | 2,898 | 7.3 7.1–7.6ROR 10.1 · χ² 16,510 / p <1e-300 | 7.3 EB05 7.1 · IC025 +2.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.3 · 89% consumer | no trial data cached |
| Rash | 1,073 | 5.4 5.1–5.7ROR 6.0 · χ² 3,913 / p <1e-300 | 5.4 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Diarrhoea (diarrhea) | 1,012 | 3.4 3.2–3.6ROR 3.7 · χ² 1,792 / p <1e-300 | 3.4 EB05 3.2 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Off label use (used outside approved label) | 799 | 2.0 1.9–2.1ROR 2.1 · χ² 419 / p 2e-93 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.2 · 83% consumer | no trial data cached |
| Malignant neoplasm progression | 767 | 16.5 15.4–17.7ROR 17.9 · χ² 11,131 / p <1e-300 | 16.4 EB05 15.4 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 9.8 | no trial data cached |
| Fatigue (tiredness) | 581 | 1.6 1.5–1.8ROR 1.7 · χ² 146 / p 7e-34 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Nausea | 540 | 1.5 1.4–1.6ROR 1.5 · χ² 90 / p 1e-21 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Drug resistance | 466 | 40.2 36.8–44.0ROR 42.2 · χ² 17,477 / p <1e-300 | 39.4 EB05 36.5 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 26.1 | no trial data cached |
| Vomiting | 451 | 2.1 1.9–2.3ROR 2.1 · χ² 263 / p 2e-59 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Disease progression | 450 | 8.3 7.6–9.1ROR 8.7 · χ² 2,903 / p <1e-300 | 8.3 EB05 7.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 | no trial data cached |
| Asthenia (weakness) | 378 | 2.2 2.0–2.4ROR 2.2 · χ² 247 / p 5e-56 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 · 73% consumer | no trial data cached |
| Decreased appetite (loss of appetite) | 376 | 3.5 3.2–3.9ROR 3.6 · χ² 689 / p 4e-152 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.2 | no trial data cached |
| Dyspnoea (shortness of breath) | 353 | 1.4 1.2–1.5ROR 1.4 · χ² 34 / p 3e-9 | 1.4 EB05 1.2 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Malaise (feeling unwell) | 352 | 1.7 1.6–1.9ROR 1.8 · χ² 113 / p 9e-27 | 1.7 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 1.7 · 86% consumer | no trial data cached |
| Anaemia (low red blood cells) | 342 | 3.9 3.5–4.3ROR 4.0 · χ² 742 / p 1e-163 | 3.9 EB05 3.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | 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.
- Erythema dyschromicum perstans — n=21, PRR 1,409.3
- Malignant transformation — n=23, PRR 117.6
- Growth of eyelashes — n=26, PRR 73.5
- Xerosis — n=21, PRR 38.0
- Metastases to meninges — n=38, PRR 37.5
- Lung adenocarcinoma — n=46, PRR 33.7
- Malignant pleural effusion — n=20, PRR 26.2
- Metastases to spine — n=32, PRR 21.0
- Adenocarcinoma — n=21, PRR 20.5
- Metastasis — n=61, PRR 18.7
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 Erlotinib?
In FDA FAERS, the most frequently co-reported reaction terms for Erlotinib are rash, diarrhoea, fatigue, nausea, vomiting, asthenia. 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 Erlotinib have an FDA boxed warning?
No. The FDA label retrieved for Erlotinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Erlotinib 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 5d97f401-4853-4a9a-907d-21e8a4d16088, effective 20210317; matched on
openfda.generic_name.exact:"ERLOTINIB") - 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, 1,002 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.