OpenClaim

Entrectinib Side Effects

The most commonly reported side effects of entrectinib include off label use, dizziness, and death, based on 1,581 FDA adverse event reports from 2017 to 2025. 4.2% of reports found the drug to be ineffective.

#1 Reported: Off Label UseAll side effects ↓Top Co-Medication: PemetrexedDrug interactions ↓55% of Reports Are AdultDemographics ↓

Entrectinib side effects

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

1
Off Label Use10.2%162
2
Dizziness9.2%146
3
Death8.5%134
4
Disease Progression7.1%112
5
Taste Disorder4.4%69
6
No Adverse Event4.2%67
7
Drug Ineffective4.2%67
8
Fatigue3.9%61
9
Constipation3.8%60
10
Nausea3.7%58
11
Blood Creatinine Increased3.6%57
12
Renal Impairment3.5%55
13
Diarrhoea3.5%55
14
Weight Increased3.2%51
15
Cardiac Failure2.9%46

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

Report severity

64.1%Serious1,014 reports
21.1%Hospitalizations333 reports
16.8%Fatal265 reports

Seriousness is determined by the reporter, not by OpenClaim.

Entrectinib drug interactions

Other drugs that appear in adverse event reports alongside entrectinib. 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
Pemetrexed3.4%53
2
Lorlatinib3.3%52
3
Bevacizumab2.8%45
4
Gemcitabine2.7%43
5
Pembrolizumab2.7%43
6
Docetaxel2.5%40
7
Capecitabine2.5%39
8
Oxaliplatin2.4%38
9
Trastuzumab2.3%37
10
Carboplatin1.8%28
11
Paclitaxel1.3%21
12
Brigatinib1.1%17
13
Cisplatin1.1%17
14
Osimertinib-mesylate1.0%16
15
Crizotinib0.9%15

Taken alongside

1
Acetaminophen2.8%45
2
Atorvastatin-calcium2.5%39
3
Furosemide2.5%39
4
Irinotecan-hydrochloride2.4%38
5
Paclitaxel2.3%37
6
Ondansetron2.1%33
7
Fluorouracil2.1%33
8
Aspirin1.9%30
9
Levoleucovorin1.9%30
10
Dexamethasone1.8%29
11
Cisplatin1.8%29
12
Bevacizumab1.8%28
13
Ethiodized-oil1.8%28
14
Amlodipine1.7%27
15
Levothyroxine-sodium1.7%27

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 entrectinib side effects

49.9% of entrectinib adverse event reports involve female patients and 39.2% involve male patients. The largest age group is adult at 55%. These figures reflect who reports side effects, not underlying risk.

Sex

Female49.9%
Male39.2%
Unknown10.9%

Age group

< 20.6%
2–112.5%
12–171.3%
18–6454.5%
65+41.2%

What is entrectinib used for

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

AdenocarcinomaAgranulocytosisAnaplastic AstrocytomaAnaplastic Lymphoma Kinase Gene And Nucleophosmin Gene Fusion OverexpressionAstrocytomaAutonomic NeuropathyAcral Lentiginous MelanomaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia RefractoryAdenocarcinomaAdenocarcinoma MetastaticAdenocarcinoma Of The CervixAdenoma BenignAdrenocortical CarcinomaAdverse Drug Reaction

Showing 15 of 214 indications

Entrectinib brand names and reporting trend

Entrectinib is sold under the brand name Rozlytrek.

Brand names

Rozlytrek777

Quarterly reports (2017–2025)

20172020202220242025

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

Taking entrectinib with another medication?

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