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Osimertinib Side Effects

The most commonly reported side effects of osimertinib include death, malignant neoplasm progression, and diarrhoea, based on 29,863 FDA adverse event reports from 2015 to 2025. 2.3% of reports found the drug to be ineffective.

Osimertinib side effects

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

1
Death36.1%10,782
2
Malignant Neoplasm Progression10.4%3,118
3
Diarrhoea5.2%1,538
4
Drug Resistance3.7%1,098
5
Fatigue3.1%913
6
Rash2.9%872
7
Decreased Appetite2.5%747
8
Off Label Use2.4%730
9
Dyspnoea2.3%692
10
Drug Ineffective2.3%689
11
Disease Progression2.3%685
12
Nausea2.3%679
13
Metastases To Central Nervous System2.1%626
14
Interstitial Lung Disease2.0%588
15
Myelosuppression1.8%549

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

Report severity

93.3%Serious27,865 reports
19.3%Hospitalizations5,766 reports
43.6%Fatal13,021 reports

Seriousness is determined by the reporter, not by OpenClaim.

Osimertinib drug interactions

Other drugs that appear in adverse event reports alongside osimertinib. 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
Gefitinib2.9%874
2
Pemetrexed1.9%577
3
Carboplatin1.8%551
4
Bevacizumab1.8%527
5
Erlotinib-hydrochloride1.3%385
6
Metoprolol0.9%267
7
Afatinib0.8%242
8
Paclitaxel0.7%209
9
Atezolizumab0.6%179
10
Pembrolizumab0.6%171
11
Amivantamab0.5%161
12
Docetaxel0.5%151
13
Omeprazole0.5%150
14
Gemcitabine0.5%138
15
Lisinopril0.4%127

Taken alongside

1
Acetaminophen1.7%499
2
Amlodipine1.7%494
3
Dexamethasone1.4%432
4
Ergocalciferol1.3%394
5
Atorvastatin-calcium1.3%387
6
Aspirin1.3%375
7
Pemetrexed1.2%359
8
Levothyroxine-sodium1.1%340
9
Apixaban1.1%329
10
Ondansetron1.1%326
11
Carboplatin1.1%315
12
Oxycodone0.9%270
13
Calcium0.9%268
14
Folic-acid0.9%267
15
Pantoprazole-sodium0.9%260

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 osimertinib side effects

56.7% of osimertinib adverse event reports involve female patients and 29.5% involve male patients. The largest age group is elderly at 63%. These figures reflect who reports side effects, not underlying risk.

Sex

Female56.7%
Male29.5%
Unknown13.8%

Age group

< 2<0.1%
2–11<0.1%
12–17<0.1%
18–6437.1%
65+62.8%

What is osimertinib used for

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

Abdominal DiscomfortAdenocarcinomaAdenosquamous Cell CarcinomaAdenosquamous Cell Lung CancerAdenovirus InfectionAdjuvant TherapyAdrenal Gland CancerAcquired Gene MutationAdenocarcinomaAdenocarcinoma GastricAdenocarcinoma MetastaticAdenosquamous Cell Lung CancerAdenosquamous Cell Lung Cancer Stage IvAdjustment DisorderAdjuvant Therapy

Showing 15 of 475 indications

Osimertinib brand names and reporting trend

Osimertinib is sold under the brand name Tagrisso.

Brand names

Tagrisso1

Quarterly reports (20152025)

2016202020242025

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

Taking osimertinib with another medication?

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