Prescription medicine
Osilodrostat Brand names: Isturisa
Osilodrostat (Isturisa) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the osilodrostat FDA label on DailyMed (effective November 18, 2025, Recordati Rare Diseases, Inc.); the NDA 212801 record on Drugs@FDA; every osilodrostat label on DailyMed.
Highlights of the record
FDA label of November 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageISTURISA is indicated for the treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative.
Forms and strengths
- 1 mg
- 5 mg
Coated tablet.
On the market
- Earliest approval on file
- March 6, 2020 Isturisa, Recordati Rare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 12, 2035 Isturisa tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,082 through July 30, 2026
What is osilodrostat used for?
From the label: indications and usageISTURISA is indicated for the treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative. ISTURISA is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative
FDA pharmacologic class: Cortisol Synthesis Inhibitor.
Source: FDA drug label (Isturisa), Recordati Rare Diseases, Inc., effective November 18, 2025 (SPL set f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2), via openFDA; the full label on DailyMed
What does the patient leaflet for osilodrostat say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ISTURISA?ISTURISA can cause serious side effects, including: Low cortisol levels in your blood (hypocortisolism). Tell your healthcare provider right away if you experience any of the following symptoms, as these may be symptoms of very low cortisol level, known as adrenal insufficiency: nausea vomiting tiredness (fatigue) low blood pressure problems with body salt (electrolyte) levels in your blood stomach (abdominal) pain loss of appetite dizziness low blood sugar If you get symptoms of hypocortisolism while taking ISTURISA, your healthcare provider may change your dose or ask you to stop taking it. Heart problem or a heart rhythm problem, such as an irregular heartbeat which could be a sign of a heart problem called QT prolongation. Call your healthcare provider right away if you have irregular heartbeats. See " What are the possible side effects of ISTURISA? " for more information about side effects.
From the patient leaflet: How should I store ISTURISA?Store ISTURISA at room temperature between 68°F to 77°F (20°C to 25°C). Keep ISTURISA dry. Keep ISTURISA and all medicines out of the reach of children.
Source: FDA drug label (Isturisa), Recordati Rare Diseases, Inc., effective November 18, 2025 (SPL set f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2), via openFDA; the full label on DailyMed
Is there a generic for osilodrostat (Isturisa)?
No generic osilodrostat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Isturisa tablets: the compound patent runs to January 13, 2031, and the last listed entry to October 12, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the osilodrostat label say about other medicines?
The osilodrostat label names 7 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Carbamazepine | drug interactions | CYP3A4 and CYP2B6 Inducers Clinical Impact: Concomitant use of ISTURISA with strong CYP3A4 and/or CYP2B6 inducers (…) may cause a decrease in osilodrostat concentration and may reduce the efficacy of ISTURISA. … Intervention: During concomitant use of ISTURISA with strong CYP3A4 and CYP2B6 inducers, monitor cortisol concentration and patient's signs and symptoms. An increase in ISTURISA dosage may be needed. … |
| Clarithromycin | drug interactions | CYP3A4 Inhibitors Clinical Impact: Concomitant use of ISTURISA with a strong CYP3A4 inhibitor (…) may cause an increase in osilodrostat concentration and may increase the risk of ISTURISA-related adverse reactions. Intervention: Reduce the dose of ISTURISA by half with concomitant use of a strong CYP3A4 inhibitor. |
| Itraconazole | drug interactions | CYP3A4 Inhibitors Clinical Impact: Concomitant use of ISTURISA with a strong CYP3A4 inhibitor (…) may cause an increase in osilodrostat concentration and may increase the risk of ISTURISA-related adverse reactions. Intervention: Reduce the dose of ISTURISA by half with concomitant use of a strong CYP3A4 inhibitor. |
| Phenobarbital | drug interactions | CYP3A4 and CYP2B6 Inducers Clinical Impact: Concomitant use of ISTURISA with strong CYP3A4 and/or CYP2B6 inducers (…) may cause a decrease in osilodrostat concentration and may reduce the efficacy of ISTURISA. … Intervention: During concomitant use of ISTURISA with strong CYP3A4 and CYP2B6 inducers, monitor cortisol concentration and patient's signs and symptoms. An increase in ISTURISA dosage may be needed. … |
| Rifampin | drug interactions | CYP3A4 and CYP2B6 Inducers Clinical Impact: Concomitant use of ISTURISA with strong CYP3A4 and/or CYP2B6 inducers (…) may cause a decrease in osilodrostat concentration and may reduce the efficacy of ISTURISA. … Intervention: During concomitant use of ISTURISA with strong CYP3A4 and CYP2B6 inducers, monitor cortisol concentration and patient's signs and symptoms. An increase in ISTURISA dosage may be needed. … |
| Theophylline | drug interactions | Clinical Impact: Concomitant use of ISTURISA with strong CYP3A4 and/or CYP2B6 inducers (…) may cause a decrease in osilodrostat concentration and may reduce the efficacy of ISTURISA. … with CYP1A2 and CYP2C19 substrates with a narrow therapeutic index, such as theophylline, tizanidine, and S-mephenytoin [see Clinical Pharmacology (12.3) ]. |
| Tizanidine | drug interactions | Clinical Impact: Concomitant use of ISTURISA with strong CYP3A4 and/or CYP2B6 inducers (…) may cause a decrease in osilodrostat concentration and may reduce the efficacy of ISTURISA. … CYP2C19 substrates with a narrow therapeutic index, such as theophylline, tizanidine, and S-mephenytoin [see Clinical Pharmacology (12.3) ]. |
Source: FDA drug label (Isturisa), Recordati Rare Diseases, Inc., effective November 18, 2025 (SPL set f3a5ec24-63c3-4d83-b1c0-6c550fbe7ae2), via openFDA; the full label on DailyMed
What do FAERS reports show for osilodrostat?
The FDA Adverse Event Reporting System holds 2,082 reports that list osilodrostat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 270 are coded as a death and 737 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other cortisol synthesis inhibitors
- the pharmacologic class, with prices and generics
- Osilodrostat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other