Pharmacologic class (EPC) · 2 drug pages

Cortisol synthesis inhibitor: adverse event reports filed with FDA

2,494 reports list a drug in this class as a suspect or interacting product, 2018–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

2,494
reports across the class: 0% of all reports; 773
reports, 12 months to June 2026: 534 in the 12 months before; 62.8%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Cortisol synthesis inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 2,494 adverse event reports received by FDA, 0% of the database, from October 2018 to June 2026.

773 reports arrived in the 12 months to June 2026, up 45% from 534 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 62.8% of the class's reports are marked serious, 9.7% record death among the outcomes and 31% record hospitalisation, as reported.

Across the class the reactions recorded most often are fatigue (20.5%), nausea (17.3%) and off label use (13.5%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
IsturisaOsilodrostat	brand	1,832	382	64.8%	Off label use
RecorlevLevoketoconazole	brand	662	391	57.3%	Fatigue

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Fatiguetiredness20.5%511
Nauseafeeling sick17.3%431
Off label useused for a purpose or in a way not on the label13.5%337
Headachehead pain11.9%297
Dizzinesslight-headedness or unsteadiness8.4%210
Diarrhoealoose or frequent stools7.6%190
Vomitingbeing sick7.6%189
Astheniaweakness or lack of energy7%174
Decreased appetitereduced appetite6.6%164
Arthralgiajoint pain5.5%137
Deaththe patient died; cause not stated by this term5.5%136
Painpain, site not specified5.4%134
Malaisegeneral feeling of being unwell4.3%108
Insomniadifficulty sleeping4.2%104
Cortisol decreased4.1%102
Feeling abnormalfeeling odd or not right4.1%102
Weight decreasedweight loss4%99
Blood glucose increasedraised blood sugar reading3.8%96
Product dose omission issuea dose was missed3.8%95
Anxietyanxiety3.6%89
Abdominal pain upperupper stomach pain3.5%88
Back painback pain3.5%88
Abdominal discomfortstomach discomfort3.4%86
Adrenal insufficiencythe adrenal glands produce too little hormone3.4%84
Weight increasedweight gain3.3%82

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death9.7%241

Life-threatening1%24

Hospitalisation (initial or prolonged)31%772

Disability0.3%8

Congenital anomaly0%0

Other serious34.8%868

Not serious37.2%927

Patient age

Under 20%1

2 to 110%0

12 to 170.1%3

18 to 448%200

45 to 6411.6%289

65 to 747.2%180

75 and over4.5%112

Age not given68.5%1,709

Who reported

Physician10.9%273

Pharmacist0.6%16

Other health professional4.8%120

Lawyer0%1

Consumer or non-health professional83.6%2,084

Not given0%0

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Cortisol synthesis inhibitor reports

Which drugs are in the Cortisol synthesis inhibitor class on this site?

Isturisa and Recorlev. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

2,494 reports through June 2026, 773 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

fatigue (20.5%), nausea (17.3%), off label use (13.5%), headache (11.9%) and dizziness (8.4%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.