Osilodrostat: uses, dosing, side effects & brands
Osilodrostat is a medicine sold in the U.S. under one brand, for cushing syndrome. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Cushing Syndrome
- Available as
- Tablet
- Sold as
- Isturisa
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How osilodrostat is dosed
From the FDA label for Isturisa (application NDA212801). Other osilodrostat products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Correct hypokalemia and hypomagnesemia, and obtain baseline electrocardiogram prior to starting ISTURISA ( 2.1 , 5.2 , 5.3 ) Initiate dosage at 2 mg orally twice daily, with or without food ( 2.2 ) Titrate dosage by 1 mg to 2 mg twice daily, no more frequently than every 2 weeks based on rate of cortisol changes, individual tolerability and improvement in signs and symptoms ( 2.2 ) Maximum recommended dosage is 30 mg twice daily ( 2.2 ) See Full Prescribing Information for complete titration, laboratory, and dosage modification recommendations ( 2.1 , 2.2 , 2.3 ) Patients with Hepatic Impairment: Child-Pugh B: Recommended starting dose is 1 mg twice daily ( 2.5 , 8.7 ) Child-Pugh C : Recommended starting dose is 1 mg once daily in the evening ( 2.5 , 8.7 ) 2.1 Laboratory Testing Prior to ISTURISA Initiation Correct hypokalemia and hypomagnesemia prior to starting ISTURISA [see Warnings and Precautions (5.2 , 5.3) ]. Obtain baseline electrocardiogram (ECG) . Repeat ECG within one week after treatment initiation, and as clinically indicated thereafter [see Warnings and Precautions (5.2) ] . 2.2 Recommended Dosage, Titration, and Monitoring Initiate dosing at 2 mg orally twice daily, with or without food. Initially, titrate the dosage by 1 mg to 2 mg twice daily, no more frequently than every 2 weeks based on the rate of cortisol changes, individual tolerability and improvement…
Osilodrostat side effects
Clinically significant adverse reactions that appear in other sections of the labeling include: Hypocortisolism [see Warnings and Precautions (5.1) ] QT Prolongation [see Warnings and Precautions (5.2) ] Elevations in Adrenal Hormone Precursors and Androgens [see Warnings and Precautions (5.3) ] Most common adverse reactions (incidence > 20%) are adrenal insufficiency, fatigue, nausea, headache, edema, decreased appetite, arthralgia, myalgia, and diarrhea ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Recordati Rare Diseases Inc. at 1-888-575-8344 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. The safety of ISTURISA was evaluated in two clinical trials in adults with Cushings disease. Study 1 (NCT02180217) was a 4-period, multicenter study with a 12-week open-label titration period, 12-week open-label maintenance period, 8-week double-blind, placebo-controlled period, and 14 to 24-week open label treatment period in 137 patients with Cushing's disease. Study 2 (NCT02697734) was a 2-period, multicenter study with a 12-week randomized, double-blind, placebo-controlled period and a…
Who shouldn’t take osilodrostat
None. None ( 4 )
Osilodrostat drug interactions
CYP3A4 Inhibitor: Reduce the dose of ISTURISA by half with concomitant use of a strong CYP3A4 inhibitor ( 7.1 ) CYP3A4 and CYP2B6 Inducers: An increase of ISTURISA dosage may be needed if ISTURISA is used concomitantly with strong CYP3A4 and CYP2B6 inducers. A reduction in ISTURISA dosage may be needed if strong CYP3A4 and CYP2B6 inducers are discontinued while using ISTURISA ( 7.1 ) 7.1 Effect of Other Drugs on ISTURISA The effect of other drugs on ISTURISA can be found in Table 3. Table 3: Effect of Other Drugs on ISTURISA CYP3A4 Inhibitors Clinical Impact: Concomitant use of ISTURISA with a strong CYP3A4 inhibitor (e.g., itraconazole, clarithromycin) may cause an increase in osilodrostat concentration and may increase the risk of ISTURISA-related adverse reactions [see Clinical Pharmacology (12.3) ] . Intervention : Reduce the dose of ISTURISA by half with concomitant use of a strong CYP3A4 inhibitor. CYP3A4 and CYP2B6 Inducers Clinical Impact: Concomitant use of ISTURISA with strong CYP3A4 and/or CYP2B6 inducers (e.g., carbamazepine, rifampin, phenobarbital) may cause a decrease in osilodrostat concentration and may reduce the efficacy of ISTURISA [see Clinical Pharmacology (12.3) ] . Discontinuation of strong CYP3A4 and/or CYP2B6 inducers while using ISTURISA may cause an increase in osilodrostat concentration and may increase the risk of ISTURISA-related adverse reactions [see Clinical Pharmacology (12.3) ] . 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. Upon discontinuation of strong CYP3A4 and CYP2B6 inducers during ISTURISA treatment, monitor cortisol concentration and patient's signs and symptoms. A reduction in ISTURISA dosage may be needed. 7.2 Effect of ISTURISA on Other Drugs ISTURISA should be used with caution when coadministered with CYP1A2 and CYP2C19 substrates with a narrow therapeutic index, such as theophylline, tizanidine, and S-mephenytoin [see Clinical Pharmacology (12.3) ] .
Every osilodrostat product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Isturisa.
What people report to the FDA about osilodrostat
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 3 reports naming osilodrostat, and the FDA flagged 100% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- acute generalised exanthematous pustulosis1 reports
- agranulocytosis1 reports
- alopecia1 reports
- contusion1 reports
- dry skin1 reports
- dyspnoea1 reports
- fatigue1 reports
- haemorrhage1 reports
Read these as a signal, not a rate. A report does not mean osilodrostat caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
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Frequently asked questions
What is osilodrostat?
Isturisa (Osilodrostat Phosphate) is a medication used to treat Cushing Syndrome.
Can you take osilodrostat with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run osilodrostat against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does osilodrostat come in?
Across the brands we track, osilodrostat is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic osilodrostat?
We do not currently list a generic-labelled osilodrostat product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Osilodrostat: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/osilodrostat
- MLA
- “Osilodrostat: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/osilodrostat.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for osilodrostat on DailyMed (NIH) ↗.