What the label lists and what reports show
Erlotinib side effects
Erlotinib's FDA label: “The most common adverse reactions (≥ 20%) with erlotinib from a pooled analysis in patients with NSCLC across all approved lines of therapy, with and without EGFR mutations, and in patients with pancreatic cancer were rash, diarrhea, anorexia, fatigue …” FAERS holds 12,438 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (1,339 reports).
- Generic listed
Check it at the source: the erlotinib FDA label on DailyMed (effective June 10, 2024, Alembic Pharmaceuticals Limited); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 20%) with erlotinib from a pooled analysis in patients with NSCLC across all approved lines of therapy, with and without EGFR mutations, and in patients with pancreatic cancer were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | All Grades % | Grades 3 to 4 % | All Grades % | Grades 3 to 4 % |
|---|---|---|---|---|
| Rash | 85 | 14 | 5 | 0 |
| Diarrhea | 62 | 5 | 21 | 1 |
| Cough | 48 | 1 | 40 | 0 |
| Dyspnea | 45 | 8 | 30 | 4 |
| Dry skin | 21 | 1 | 2 | 0 |
| Back pain | 19 | 2 | 5 | 0 |
| Chest pain | 18 | 1 | 12 | 0 |
| Conjunctivitis | 18 | 0 | 0 | 0 |
| Mucosal inflammation | 18 | 1 | 6 | 0 |
| Pruritus | 16 | 0 | 1 | 0 |
| Paronychia | 14 | 0 | 0 | 0 |
| Arthralgia | 13 | 1 | 6 | 1 |
| Musculoskeletal pain | 11 | 1 | 1 | 0 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions, which may include fatalities, are discussed in greater detail in other sections of the labeling: Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.1)] Renal Failure [see Warnings and Precautions (5.2)] Hepatotoxicity with or without Hepatic Impairment [see Warnings and Precautions (5.3)] Gastrointestinal Perforation [see Warnings and Precautions (5.4)] Bullous and Exfoliative Skin Disorders [see Warnings and Precautions (5.5)] Cerebrovascular Accident [see Warnings and Precautions (5.6)] Microangiopathic Hemolytic Anemia with Thrombocytopenia [see Warnings and Precautions (5.7)] Ocular Disorders [see Warnings and Precautions (5.8)] Hemorrhage in Patients Taking Warfarin [see Warnings and Precautions (5.9)] The most common adverse reactions (≥ 20%) with erlotinib from a pooled analysis in patients with NSCLC across all approved lines of therapy, with and without EGFR mutations, and in patients with pancreatic cancer were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting. …
Source: FDA drug label, Alembic Pharmaceuticals Limited, effective June 10, 2024 (SPL set ab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b), via openFDA; the full label on DailyMed
What do FAERS reports show?
12,438 reports list erlotinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,765 are coded as a death and 3,881 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Erlotinib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions