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Osilodrostat Side Effects

The most commonly reported side effects of osilodrostat include off label use, fatigue, and nausea, based on 1,800 FDA adverse event reports from 2020 to 2025.

Osilodrostat side effects

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

1
Off Label Use16.5%297
2
Fatigue14.3%258
3
Nausea11.9%214
4
Headache6.4%116
5
Death6.2%112
6
Asthenia5.8%104
7
Dizziness5.6%100
8
Adrenal Insufficiency5.4%98
9
Diarrhoea5.4%97
10
Decreased Appetite5.3%96
11
Vomiting5.1%92
12
Cortisol Decreased4.1%73
13
Arthralgia3.7%67
14
Covid-193.7%67
15
Product Dose Omission Issue2.9%52

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

Report severity

66.6%Serious1,198 reports
34.8%Hospitalizations626 reports
12.4%Fatal223 reports

Seriousness is determined by the reporter, not by OpenClaim.

Osilodrostat drug interactions

Other drugs that appear in adverse event reports alongside osilodrostat. 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
Pasireotide1.9%35
2
Metformin1.4%26
3
Phenazopyridine-hydrochloride1.4%26
4
Lidocaine1.4%25
5
Mitotane1.3%24
6
Carboplatin1.3%24
7
Spironolactone1.2%22
8
Etoposide1.2%21
9
Metyrapone1.1%19
10
Ketoconazole0.9%17
11
Hydrocortisone0.9%16
12
Pembrolizumab0.8%15
13
Levothyroxine-sodium0.8%14
14
Potassium-chloride0.7%13
15
Amlodipine0.7%12

Taken alongside

1
Levothyroxine-sodium20.7%372
2
Ergocalciferol20.6%370
3
Spironolactone17.6%316
4
Metformin14.3%257
5
Insulin14.0%252
6
Atorvastatin-calcium13.3%240
7
Amlodipine12.2%220
8
Metoprolol10.7%192
9
Acetaminophen9.4%169
10
Potassium-chloride9.4%169
11
Gabapentin9.3%167
12
Furosemide9.0%162
13
Aspirin8.4%151
14
Lisinopril8.3%149
15
Hydrocortisone7.9%142

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 osilodrostat side effects

25.5% of osilodrostat adverse event reports involve female patients and 10.2% involve male patients. The largest age group is adult at 66%. These figures reflect who reports side effects, not underlying risk.

Sex

Female25.5%
Male10.2%
Unknown64.3%

Age group

< 20.4%
2–110.2%
12–170.6%
18–6465.6%
65+33.3%

What is osilodrostat used for

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

Acth-producing Pituitary TumourAdrenal Gland CancerAdenocarcinoma MetastaticAdrenal AdenomaAdrenal DisorderAdrenal Gland CancerAdrenal Gland Cancer MetastaticAdrenocortical CarcinomaBenign NeoplasmBenign Neoplasm Of Adrenal GlandBlood Test AbnormalCardiac DisorderCortisol AbnormalCortisol DecreasedCortisol Increased

Showing 15 of 66 indications

Osilodrostat brand names and reporting trend

Osilodrostat is sold under the brand name Isturisa.

Brand names

Isturisa376

Quarterly reports (20202025)

2020202220242025

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

Taking osilodrostat with another medication?

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