Pharmacologic class (EPC) · 2 drug pages

Adrenocorticotropic hormone: adverse event reports filed with FDA

4,963 reports list a drug in this class as a suspect or interacting product, 2011–2026.

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.

4,963
reports across the class: 0% of all reports; 1,853
reports, 12 months to June 2026: 26 in the 12 months before; 50.9%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Adrenocorticotropic hormone 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 4,963 adverse event reports received by FDA, 0% of the database, from February 2011 to June 2026.

1,853 reports arrived in the 12 months to June 2026, up 7027% from 26 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 50.9% of the class's reports are marked serious, 2.5% record death among the outcomes and 21.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are fatigue (12.4%), injection site bruising (9.2%) and weight increased (9%). 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
Repository corticotropin	generic	2,695	0	62%	Fatigue
ActharRepository corticotropin	brand	2,268	1,853	37.8%	Injection site bruising

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

Fatiguetiredness12.4%616
Injection site bruisingbruising where the injection was given9.2%457
Weight increasedweight gain9%446
Malaisegeneral feeling of being unwell8.1%400
Drug ineffectivethe medicine did not work as expected8%396
Insomniadifficulty sleeping7.7%384
Headachehead pain7.4%369
Dyspnoeashortness of breath6.7%334
Painpain, site not specified6.5%321
Injection site painpain where the injection was given6.3%313
Peripheral swellingswelling of the arms or legs6.2%308
Astheniaweakness or lack of energy5.9%294
Fluid retentionthe body holding extra fluid5.8%286
Blood glucose increasedraised blood sugar reading5.5%271
Blood pressure increaseda raised blood pressure reading5.4%268
Nauseafeeling sick4.6%229
Dizzinesslight-headedness or unsteadiness4.4%218
Hypertensionhigh blood pressure4.3%215
Condition aggravatedthe condition being treated got worse4.2%208
Falla fall4.1%202
Arthralgiajoint pain3.8%189
Feeling abnormalfeeling odd or not right3.7%184
Pain in extremitypain in an arm or leg3.6%181
Swellingswelling3.6%180
Drug dose omissiona dose was missed3.5%173

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

Death2.5%124

Life-threatening0.4%21

Hospitalisation (initial or prolonged)21.5%1,069

Disability0.6%28

Congenital anomaly0%0

Other serious35.9%1,782

Not serious49.1%2,436

Patient age

Under 21%48

2 to 110.3%17

12 to 170.3%14

18 to 4411.1%551

45 to 6428.1%1,395

65 to 7412.9%639

75 and over5.5%274

Age not given40.8%2,025

Who reported

Physician3.2%157

Pharmacist3.1%156

Other health professional5.4%268

Lawyer0%0

Consumer or non-health professional87.6%4,349

Not given0.7%33

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 Adrenocorticotropic hormone reports

Which drugs are in the Adrenocorticotropic hormone class on this site?

Repository corticotropin and Acthar. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

4,963 reports through June 2026, 1,853 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 (12.4%), injection site bruising (9.2%), weight increased (9%), malaise (8.1%) and drug ineffective (8%).

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.