OpenClaim

Selumetinib Side Effects

The most commonly reported side effects of selumetinib include blood creatine phosphokinase increased, rash, and off label use, based on 1,277 FDA adverse event reports from 2007 to 2025. 2.5% of reports found the drug to be ineffective.

Selumetinib side effects

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

1
Blood Creatine Phosphokinase Increased8.4%107
2
Rash8.0%102
3
Off Label Use7.7%98
4
Paronychia6.0%77
5
Dermatitis Acneiform4.9%63
6
Diarrhoea4.8%61
7
Acne4.6%59
8
Nausea4.5%57
9
Fatigue4.4%56
10
Alopecia4.0%51
11
Death3.8%49
12
Vomiting3.3%42
13
Abdominal Pain2.7%35
14
Headache2.7%34
15
Pain2.6%33

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

Report severity

80.3%Serious1,026 reports
17.9%Hospitalizations228 reports
6.7%Fatal85 reports

Seriousness is determined by the reporter, not by OpenClaim.

Selumetinib drug interactions

Other drugs that appear in adverse event reports alongside selumetinib. 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
Bevacizumab0.7%9
2
Everolimus0.6%8
3
Trametinib0.6%8
4
Erlotinib-hydrochloride0.5%7
5
Temsirolimus0.5%6
6
Vandetanib0.5%6
7
Carboplatin0.5%6
8
Acetaminophen0.5%6
9
Temozolomide0.4%5
10
Oxycodone0.4%5
11
Gemcitabine0.4%5
12
Cisplatin0.4%5
13
Osimertinib-mesylate0.4%5
14
Irinotecan-hydrochloride0.3%4
15
Vincristine-sulfate0.3%4

Taken alongside

1
Ondansetron7.4%95
2
Acetaminophen6.0%77
3
Gabapentin3.5%45
4
Ergocalciferol3.2%41
5
Clindamycin3.1%39
6
Ibuprofen2.9%37
7
Loperamide-hydrochloride2.8%36
8
Cetirizine-hydrochloride2.7%34
9
Albuterol2.0%25
10
Hydrocortisone1.9%24
11
Doxycycline1.9%24
12
Polyethylene-glycol-33501.7%22
13
Aspirin1.6%21
14
Methylphenidate1.6%21
15
Levothyroxine-sodium1.6%20

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 selumetinib side effects

41.0% of selumetinib adverse event reports involve female patients and 41.3% involve male patients. The largest age group is adolescent at 38%. These figures reflect who reports side effects, not underlying risk.

Sex

Female41.0%
Male41.3%
Unknown17.7%

Age group

< 20.3%
2–1131.8%
12–1738.0%
18–6424.9%
65+5.0%

What is selumetinib used for

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

Acute Lymphocytic LeukaemiaAcoustic NeuromaAcute Lymphocytic LeukaemiaAddison^s DiseaseAdenocarcinomaAdrenal NeoplasmAnal CancerArthralgiaAstrocytomaAstrocytoma, Low GradeAutonomic Nervous System ImbalanceBenign NeoplasmBrain NeoplasmBrain Neoplasm MalignantBronchioloalveolar Carcinoma

Showing 15 of 113 indications

Selumetinib brand names and reporting trend

Selumetinib is sold under the brand name Koselugo.

Brand names

Koselugo746

Quarterly reports (20072025)

200720152025

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

Taking selumetinib with another medication?

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