Drug · FAERS side-effect profile with label screen
Erlotinib Hydrochloride side effects: what 12,438 FDA adverse event reports show
Drug class
Not stated in label
Who reports
12,438 reports · 98% serious · 5,765 with death outcome · 50% 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 2Not in label — unassessed 24
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. 971 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 | 1,090.9 629.3–1,891.0ROR 1,092.7 · χ² 13,155 / p <1e-300 | 411.3 EB05 283.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=12 · 100% clinician | no trial data cached |
| Laryngeal papilloma | 12 | 569.9 295.9–1,097.6ROR 570.5 · χ² 4,660 / p <1e-300 | 253.5 EB05 154.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Respiratory papilloma | 12 | 474.9 250.1–901.9ROR 475.4 · χ² 4,053 / p <1e-300 | 232.9 EB05 142.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Egfr gene mutation | 69 | 377.3 290.7–489.7ROR 379.4 · χ² 20,800 / p <1e-300 | 283.5 EB05 231.7 · IC025 +6.2 3/3 methods agree | Labeled (related wording) related wording | serious n=69 | no trial data cached |
| Trichomegaly | 11 | 225.7 120.3–423.7ROR 225.9 · χ² 1,973 / p <1e-300 | 148.3 EB05 88.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Malignant transformation | 24 | 95.2 63.1–143.6ROR 95.4 · χ² 2,028 / p <1e-300 | 84.3 EB05 59.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 90% (drug 50%) · 100% clinician | no trial data cached |
| Bronchial fistula | 10 | 90.3 47.8–170.7ROR 90.4 · χ² 755 / p 1e-166 | 74.1 EB05 43.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Lung adenocarcinoma stage iv | 19 | 88.7 55.9–140.7ROR 88.9 · χ² 1,482 / p <1e-300 | 77.9 EB05 52.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Acquired gene mutation | 65 | 87.3 68.1–111.9ROR 87.7 · χ² 5,186 / p <1e-300 | 81.1 EB05 65.8 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=64 | no trial data cached |
| Lung adenocarcinoma metastatic | 11 | 82.4 45.0–150.9ROR 82.4 · χ² 767 / p 5e-169 | 69.5 EB05 41.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Non-small cell lung cancer metastatic | 38 | 77.9 56.3–107.8ROR 78.1 · χ² 2,682 / p <1e-300 | 71.9 EB05 54.7 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=38 | no trial data cached |
| Metastases to thorax | 11 | 76.2 41.6–139.4ROR 76.3 · χ² 710 / p 9e-157 | 65.0 EB05 38.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Trichiasis | 12 | 68.1 38.2–121.2ROR 68.1 · χ² 699 / p 3e-154 | 59.6 EB05 36.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Dermatitis acneiform | 231 | 66.9 58.7–76.2ROR 68.1 · χ² 14,353 / p <1e-300 | 64.0 EB05 57.4 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=223 | no trial data cached |
| Non-small cell lung cancer stage iv | 13 | 63.0 36.2–109.6ROR 63.1 · χ² 706 / p 9e-156 | 56.0 EB05 34.8 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Growth of eyelashes | 26 | 56.9 38.5–84.0ROR 57.0 · χ² 1,326 / p 1e-290 | 53.0 EB05 38.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 71% (drug 50%) | no trial data cached |
| Paronychia | 134 | 53.8 45.4–63.9ROR 54.4 · χ² 6,682 / p <1e-300 | 51.8 EB05 44.9 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=131 | no trial data cached |
| Non-small cell lung cancer | 137 | 50.3 42.4–59.5ROR 50.8 · χ² 6,374 / p <1e-300 | 48.5 EB05 42.1 · IC025 +5.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=136 | no trial data cached |
| Metastases to the mediastinum | 11 | 45.8 25.2–83.4ROR 45.9 · χ² 427 / p 4e-95 | 41.7 EB05 24.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Lung adenocarcinoma | 77 | 44.1 35.2–55.2ROR 44.3 · χ² 3,116 / p <1e-300 | 42.5 EB05 35.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=77 · 93% clinician | no trial data cached |
| Malignant pleural effusion | 38 | 38.9 28.2–53.7ROR 39.0 · χ² 1,335 / p 1e-292 | 37.4 EB05 28.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=40 | no trial data cached |
| Xerosis | 25 | 35.1 23.6–52.2ROR 35.2 · χ² 779 / p 1e-171 | 33.6 EB05 24.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | no trial data cached |
| Hepatobiliary disease | 12 | 32.7 18.5–57.9ROR 32.7 · χ² 331 / p 3e-74 | 30.7 EB05 18.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Metastases to meninges | 42 | 32.2 23.7–43.6ROR 32.3 · χ² 1,214 / p 3e-266 | 31.2 EB05 24.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=42 | no trial data cached |
| Drug resistance | 474 | 31.7 29.0–34.6ROR 32.9 · χ² 13,805 / p <1e-300 | 31.1 EB05 28.8 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 20.5 | no trial data cached |
| Corneal epithelium defect | 10 | 29.8 16.0–55.8ROR 29.9 · χ² 246 / p 9e-56 | 27.8 EB05 16.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Lung cancer metastatic | 49 | 29.2 22.0–38.7ROR 29.3 · χ² 1,284 / p 2e-281 | 28.4 EB05 22.4 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=50 | no trial data cached |
| Pancreatic carcinoma metastatic | 43 | 25.7 19.1–34.8ROR 25.8 · χ² 983 / p 5e-216 | 25.1 EB05 19.4 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=43 | no trial data cached |
| Metastases to pleura | 15 | 24.6 14.8–41.0ROR 24.6 · χ² 312 / p 4e-70 | 23.6 EB05 15.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Skin toxicity | 72 | 22.0 17.5–27.8ROR 22.1 · χ² 1,406 / p <1e-300 | 21.6 EB05 17.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=70 | no trial data cached |
| Multiple-drug resistance | 39 | 21.5 15.7–29.5ROR 21.6 · χ² 733 / p 1e-161 | 21.0 EB05 16.0 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious n=39 · ♀ 73% (drug 50%) · 95% clinician | no trial data cached |
| Gastrointestinal toxicity | 57 | 20.6 15.9–26.8ROR 20.7 · χ² 1,033 / p 5e-227 | 20.3 EB05 16.2 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious n=56 | no trial data cached |
| Gene mutation | 23 | 19.7 13.1–29.7ROR 19.8 · χ² 386 / p 3e-86 | 19.2 EB05 13.3 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · 100% clinician | no trial data cached |
| Lymphangiosis carcinomatosa | 12 | 19.6 11.1–34.6ROR 19.6 · χ² 192 / p 7e-44 | 18.5 EB05 10.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Small cell lung cancer | 16 | 18.7 11.4–30.5ROR 18.7 · χ² 247 / p 5e-56 | 17.9 EB05 11.3 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=16 | no trial data cached |
| Pneumoperitoneum | 20 | 18.6 12.0–28.9ROR 18.6 · χ² 312 / p 3e-70 | 18.0 EB05 12.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=20 | no trial data cached |
| Radiation pneumonitis | 22 | 17.5 11.5–26.6ROR 17.5 · χ² 322 / p 3e-72 | 16.9 EB05 11.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=22 | no trial data cached |
| Metastases to central nervous system | 131 | 17.4 14.7–20.7ROR 17.6 · χ² 1,990 / p <1e-300 | 17.2 EB05 14.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 | no trial data cached |
| Metastases to spine | 33 | 16.7 11.9–23.6ROR 16.8 · χ² 468 / p 4e-104 | 16.4 EB05 12.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=33 · 79% consumer | no trial data cached |
| Rash pustular | 70 | 16.3 12.9–20.6ROR 16.3 · χ² 978 / p 5e-215 | 16.0 EB05 13.1 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=67 | 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 | 3,659 | 7.2 7.0–7.4ROR 9.8 · χ² 20,231 / p <1e-300 | 7.2 EB05 7.0 · IC025 +2.8 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.2 · 73% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 1,338 | 3.5 3.3–3.7ROR 3.8 · χ² 2,472 / p <1e-300 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Rash | 1,317 | 5.1 4.9–5.4ROR 5.6 · χ² 4,456 / p <1e-300 | 5.1 EB05 4.9 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 | no trial data cached |
| Off label use (used outside approved label) | 904 | 1.8 1.6–1.9ROR 1.8 · χ² 306 / p 7e-69 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 1.9 · 75% consumer | no trial data cached |
| Malignant neoplasm progression | 890 | 14.8 13.9–15.8ROR 15.9 · χ² 11,435 / p <1e-300 | 14.7 EB05 13.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 | no trial data cached |
| Fatigue (tiredness) | 717 | 1.6 1.4–1.7ROR 1.6 · χ² 147 / p 3e-34 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Nausea | 694 | 1.5 1.4–1.6ROR 1.5 · χ² 113 / p 1e-26 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Vomiting | 576 | 2.1 1.9–2.2ROR 2.1 · χ² 325 / p 5e-73 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Disease progression | 572 | 8.2 7.6–8.9ROR 8.6 · χ² 3,618 / p <1e-300 | 8.1 EB05 7.6 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 91% clinician | no trial data cached |
| Decreased appetite (loss of appetite) | 511 | 3.7 3.4–4.1ROR 3.8 · χ² 1,025 / p 3e-225 | 3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Anaemia (low red blood cells) | 496 | 4.4 4.0–4.8ROR 4.5 · χ² 1,303 / p 1e-285 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Dyspnoea (shortness of breath) | 484 | 1.4 1.3–1.6ROR 1.5 · χ² 67 / p 1e-16 | 1.4 EB05 1.3 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Drug resistance | 474 | 31.7 29.0–34.6ROR 32.9 · χ² 13,805 / p <1e-300 | 31.1 EB05 28.8 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious PRR 20.5 | no trial data cached |
| Asthenia (weakness) | 462 | 2.1 1.9–2.3ROR 2.1 · χ² 260 / p 1e-58 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Pneumonia (lung infection) | 419 | 2.2 2.0–2.4ROR 2.2 · χ² 272 / p 2e-61 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | 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.
- Erythema dyschromicum perstans — n=21, PRR 1,090.9
- Malignant transformation — n=24, PRR 95.2
- Growth of eyelashes — n=26, PRR 56.9
- Lung adenocarcinoma — n=77, PRR 44.1
- Malignant pleural effusion — n=38, PRR 38.9
- Xerosis — n=25, PRR 35.1
- Metastases to meninges — n=42, PRR 32.2
- Pneumoperitoneum — n=20, PRR 18.6
- Radiation pneumonitis — n=22, PRR 17.5
- Metastases to central nervous system — n=131, PRR 17.4
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 diarrhoea, rash, fatigue, nausea, vomiting, decreased appetite. 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, 1,011 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.