Acthar: adverse event reports filed with FDA

2,268

reports as suspect product

0% of all reports · about 147 a year

1,853

reports, 12 months to June 2026

26 in the 12 months before

37.8%

marked serious by the reporter

50.9% across the class

1.3%

record death among outcomes, as reported

29 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Acthar reports recording the termmedian drug in adrenocorticotropic hormone

1. Injection site bruisingbruising where the injection was given9%203
2. Fatiguetiredness8.5%193
3. Injection site painpain where the injection was given7.3%165
4. Product dose omission issuea dose was missed6.3%142
5. Insomniadifficulty sleeping5.6%128
6. Headachehead pain5.4%123
7. Weight increasedweight gain4.5%103
8. Drug ineffectivethe medicine did not work as expected4.3%98
9. Peripheral swellingswelling of the arms or legs4.1%94
10. Condition aggravatedthe condition being treated got worse4.1%92
11. Blood glucose increasedraised blood sugar reading3.8%86
12. Painpain, site not specified3.5%80
13. Fluid retentionthe body holding extra fluid3.4%76
14. Inappropriate schedule of product administrationthe product was taken at the wrong times3.3%75
15. Injection site pruritusitching where the injection was given3.3%75
16. Astheniaweakness or lack of energy3%68
17. Hypertensionhigh blood pressure2.9%66
18. Injection site haemorrhagebleeding where the injection was given2.9%65
19. Blood pressure increaseda raised blood pressure reading2.7%62
20. Swellingswelling2.6%58
21. Illness2.4%55
22. Injection site discharge2.4%55
23. Malaisegeneral feeling of being unwell2.4%55
24. Injection site erythemaredness where the injection was given2.4%54
25. Dyspnoeashortness of breath2.2%50
26. Nauseafeeling sick2.2%49
27. Dizzinesslight-headedness or unsteadiness2.1%48
28. Feeling abnormalfeeling odd or not right2.1%48
29. Injection site swellingswelling where the injection was given2.1%48
30. Falla fall2.1%47

Top 30 of 512 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the adrenocorticotropic hormone class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 4,963 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 2,268 reports.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the adrenocorticotropic hormone class

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." A brand and its generic are separate rows because reporters name them separately.

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 report counts here when it lists Acthar as a suspect or interacting product; reports listing it only as a concomitant medication (464) are excluded. 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.