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Nirogacestat Side Effects

The most commonly reported side effects of nirogacestat include diarrhoea, nausea, and fatigue, based on 756 FDA adverse event reports from 2013 to 2025.

Nirogacestat side effects

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

1
Diarrhoea37.2%281
2
Nausea23.7%179
3
Fatigue19.4%147
4
Rash12.7%96
5
Headache10.1%76
6
Product Dose Omission Issue9.7%73
7
Vomiting9.3%70
8
Stomatitis7.1%54
9
Cough5.8%44
10
Intentional Underdose5.4%41
11
Pruritus5.0%38
12
Product Dose Omission In Error5.0%38
13
Alopecia4.9%37
14
Abdominal Discomfort4.8%36
15
Epistaxis4.6%35

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

Report severity

24.5%Serious185 reports
11.9%Hospitalizations90 reports
1.1%Fatal8 reports

Seriousness is determined by the reporter, not by OpenClaim.

Nirogacestat drug interactions

Other drugs that appear in adverse event reports alongside nirogacestat. 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
Pomalidomide2.1%16
2
Belantamab-mafodotin-blmf2.0%15
3
Teclistamab-cqyv1.7%13
4
Lenalidomide1.3%10
5
Dexamethasone1.2%9
6
Sorafenib-tosylate0.9%7
7
Daratumumab0.9%7
8
Bortezomib0.9%7
9
Loperamide-hydrochloride0.8%6
10
Doxorubicin-hydrochloride0.7%5
11
Tamsulosin-hydrochloride0.5%4
12
Imatinib-mesylate0.5%4
13
Methotrexate0.5%4
14
Vinblastine-sulfate0.5%4
15
Pazopanib-hydrochloride0.5%4

Taken alongside

1
Ondansetron2.9%22
2
Acetaminophen2.5%19
3
Acyclovir2.0%15
4
Gabapentin2.0%15
5
Oxycodone2.0%15
6
Omeprazole1.6%12
7
Loperamide-hydrochloride1.6%12
8
Ergocalciferol1.5%11
9
Pregabalin1.3%10
10
Morphine-sulfate1.3%10
11
Prochlorperazine1.3%10
12
Sulfamethoxazole1.2%9
13
Trimethoprim1.2%9
14
Levothyroxine-sodium1.2%9
15
Ibuprofen1.2%9

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 nirogacestat side effects

56.6% of nirogacestat adverse event reports involve female patients and 28.2% involve male patients. The largest age group is adult at 78%. These figures reflect who reports side effects, not underlying risk.

Sex

Female56.6%
Male28.2%
Unknown15.2%

Age group

< 20.0%
2–111.2%
12–175.5%
18–6478.3%
65+15.0%

What is nirogacestat used for

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

Abdominal DiscomfortAbdominal NeoplasmAdenomatous Polyposis ColiBone NeoplasmBreast CancerConnective Tissue NeoplasmDesmoid TumourDiarrhoeaDisease RecurrenceFibrous Dysplasia Of BoneGlaucomaGastrointestinal Stromal TumourJuvenile AngiofibromaKeloid ScarMesenteric Neoplasm

Showing 15 of 25 indications

Nirogacestat brand names and reporting trend

Nirogacestat is sold under the brand name Ogsiveo.

Brand names

Ogsiveo840

Quarterly reports (20132025)

201320242025

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

Taking nirogacestat with another medication?

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