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Erlotinib Side Effects

The most commonly reported side effects of erlotinib include death, rash, and diarrhoea, based on 45,512 FDA adverse event reports from 2004 to 2025. 3.0% of reports found the drug to be ineffective.

Erlotinib side effects

Percentages show how often each reaction appears relative to total reports for erlotinib.

1
Death30.6%13,911
2
Rash12.7%5,768
3
Diarrhoea9.3%4,234
4
Fatigue4.1%1,849
5
Nausea3.8%1,713
6
Death3.7%1,698
7
Malignant Neoplasm Progression3.6%1,626
8
Off Label Use3.2%1,456
9
Disease Progression3.1%1,410
10
Drug Ineffective3.0%1,355
11
Decreased Appetite2.8%1,259
12
Diarrhoea2.6%1,165
13
Dry Skin2.3%1,069
14
Vomiting2.3%1,068
15
Rash2.3%1,027

These are voluntary reports and do not establish that erlotinib caused these reactions.

Report severity

79.3%Serious36,092 reports
21.7%Hospitalizations9,892 reports
46.3%Fatal21,078 reports

Seriousness is determined by the reporter, not by OpenClaim.

Erlotinib drug interactions

Other drugs that appear in adverse event reports alongside erlotinib. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Bevacizumab8.1%3,708
2
Gemcitabine3.5%1,600
3
Carboplatin1.8%806
4
Pemetrexed1.6%710
5
Paclitaxel1.4%641
6
Capecitabine1.3%595
7
Docetaxel1.1%480
8
Osimertinib-mesylate1.0%473
9
Cisplatin1.0%451
10
Sorafenib-tosylate0.8%350
11
Gefitinib0.8%349
12
Oxaliplatin0.5%239
13
Ramucirumab0.4%180
14
Fluorouracil0.4%173
15
Afatinib0.4%161

Taken alongside

1
Acetaminophen4.6%2,082
2
Dexamethasone3.4%1,565
3
Aspirin3.4%1,539
4
Ondansetron3.1%1,433
5
Oxycodone3.1%1,430
6
Omeprazole2.8%1,275
7
Amlodipine2.7%1,229
8
Levothyroxine-sodium2.7%1,211
9
Albuterol2.5%1,136
10
Metoprolol2.5%1,120
11
Furosemide2.4%1,090
12
Folic-acid2.2%1,015
13
Hydrocodone2.2%1,014
14
Prochlorperazine2.2%986
15
Lorazepam2.1%976

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports erlotinib side effects

49.2% of erlotinib adverse event reports involve female patients and 44.3% involve male patients. The largest age group is elderly at 58%. These figures reflect who reports side effects, not underlying risk.

Sex

Female49.2%
Male44.3%
Unknown6.5%

Age group

< 2<0.1%
2–110.2%
12–170.2%
18–6441.3%
65+58.2%

What is erlotinib used for

Conditions and purposes for which patients were taking erlotinib when the adverse event was reported.

Abdominal NeoplasmAcneAcquired Gene MutationAcute Kidney InjuryAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma LungAdenocarcinoma Of ColonAdenocarcinoma PancreasAdenoid Cystic CarcinomaAdenoma BenignAdenomatous Polyposis Coli

Showing 15 of 740 indications

Erlotinib brand names and reporting trend

Erlotinib is sold under the brand name Tarceva.

Brand names

Tarceva1

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking erlotinib with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.