OpenClaim

Gefitinib Side Effects

The most commonly reported side effects of gefitinib include malignant neoplasm progression, drug resistance, and death, based on 8,715 FDA adverse event reports from 2004 to 2025. 2.5% of reports found the drug to be ineffective.

Gefitinib side effects

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

1
Malignant Neoplasm Progression19.5%1,702
2
Drug Resistance14.3%1,246
3
Death7.6%666
4
Diarrhoea5.1%446
5
Diarrhoea4.9%430
6
Rash4.0%351
7
Metastases To Central Nervous System3.7%324
8
Interstitial Lung Disease3.1%269
9
Disease Progression3.1%268
10
Rash3.0%262
11
Acquired Gene Mutation3.0%258
12
Drug Ineffective2.5%218
13
Pneumonia2.3%200
14
Off Label Use2.3%198
15
Nausea2.2%196

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

Report severity

94.9%Serious8,270 reports
29.4%Hospitalizations2,565 reports
22.3%Fatal1,943 reports

Seriousness is determined by the reporter, not by OpenClaim.

Gefitinib drug interactions

Other drugs that appear in adverse event reports alongside gefitinib. 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
Osimertinib-mesylate9.8%854
2
Erlotinib-hydrochloride3.9%343
3
Carboplatin3.6%312
4
Pemetrexed3.5%301
5
Bevacizumab3.1%268
6
Docetaxel2.7%233
7
Paclitaxel2.1%185
8
Cisplatin1.8%160
9
Gemcitabine1.6%140
10
Afatinib1.2%107
11
Vinorelbine-tartrate1.1%99
12
Fluorouracil0.8%67
13
Irinotecan-hydrochloride0.7%58
14
Metoprolol0.6%54
15
Atezolizumab0.6%54

Taken alongside

1
Carboplatin4.0%352
2
Amlodipine2.7%232
3
Paclitaxel2.6%230
4
Acetaminophen2.6%230
5
Oxycodone2.6%226
6
Dexamethasone2.5%218
7
Cisplatin2.4%213
8
Pemetrexed2.4%206
9
Gemcitabine2.3%204
10
Aspirin2.2%189
11
Furosemide2.0%170
12
Docetaxel1.9%168
13
Prednisone1.7%145
14
Vinorelbine-tartrate1.5%134
15
Osimertinib-mesylate1.5%129

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 gefitinib side effects

53.8% of gefitinib adverse event reports involve female patients and 36.2% involve male patients. The largest age group is elderly at 57%. These figures reflect who reports side effects, not underlying risk.

Sex

Female53.8%
Male36.2%
Unknown10.0%

Age group

< 2<0.1%
2–110.2%
12–170.2%
18–6442.7%
65+56.9%

What is gefitinib used for

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

Acute Myeloid LeukaemiaAdenocarcinomaAdenocarcinoma Of The CervixAdenocarcinoma PancreasAdenosquamous Cell CarcinomaAdenosquamous Cell Lung CancerAdenosquamous Cell Lung Cancer Stage IAdenosquamous Cell Lung Cancer Stage IvAdrenal CarcinomaAdrenocortical CarcinomaAmino Acid Level IncreasedAnal UlcerAcquired Gene MutationAcute Myeloid LeukaemiaAdenocarcinoma

Showing 15 of 295 indications

Gefitinib brand names and reporting trend

Gefitinib is sold under the brand name Iressa.

Brand names

Iressa2,384

Quarterly reports (20042025)

20052010201520202025

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

Taking gefitinib with another medication?

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