H P Acthar adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name H P Acthar
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Product name as reported

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Reports on file

From August 2006 to June 2026, FDA received 3,412 adverse event reports that name H P Acthar. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 147 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 5 reports in the 12 months to June 2026 and 6 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which H P Acthar is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 1 report that names H P Acthar.
In January to March 2026, FDA received 1.
In April to June 2025, FDA received 2.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 285 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 3,360 of the 3,412 reports (98.5%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 285 terms.

Reaction terms in the reports that name H P Acthar, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,412 reports
Deaththe patient died; cause not stated by this term	200	5.9%
Drug ineffectivethe medicine did not work as expected	184	5.4%
Weight increasedweight gain	166	4.9%
Fatiguetiredness	157	4.6%
Injection site bruisingbruising where the injection was given	141	4.1%
Dyspnoeashortness of breath	135	4%
Insomniadifficulty sleeping	134	3.9%
Condition aggravatedthe condition being treated got worse	124	3.6%
Multiple sclerosis relapsea flare of multiple sclerosis	119	3.5%
Peripheral swellingswelling of the arms or legs	117	3.4%
Headachehead pain	113	3.3%
Painpain, site not specified	111	3.3%
Blood glucose increasedraised blood sugar reading	108	3.2%
Blood pressure increaseda raised blood pressure reading	105	3.1%
Malaisegeneral feeling of being unwell	103	3%
Astheniaweakness or lack of energy	100	2.9%
Product dose omission issuea dose was missed	98	2.9%
Falla fall	94	2.8%
Fluid retentionthe body holding extra fluid	92	2.7%
Hypertensionhigh blood pressure	86	2.5%
Nauseafeeling sick	86	2.5%
Diarrhoealoose or frequent stools	82	2.4%
Dizzinesslight-headedness or unsteadiness	76	2.2%
Injection site painpain where the injection was given	75	2.2%
Swelling	75	2.2%
Pneumonialung infection	74	2.2%
Covid-19COVID-19 infection	73	2.1%
Arthralgiajoint pain	72	2.1%
Pain in extremitypain in an arm or leg	69	2%
Feeling abnormalfeeling odd or not right	64	1.9%
Gait disturbancedifficulty walking	62	1.8%
Drug dose omissiona dose was missed	60	1.8%
Swelling facea swollen face	60	1.8%
Hospitalisationadmission to hospital	58	1.7%
Rashskin rash	54	1.6%
Anxiety	52	1.5%
Muscle spasmsmuscle cramps	52	1.5%
Therapy cessation	52	1.5%
Vomitingbeing sick	51	1.5%
Weight decreasedweight loss	51	1.5%
Injection site pruritusitching where the injection was given	49	1.4%
Alopeciahair loss	48	1.4%
Contusiona bruise	47	1.4%
Irritability	47	1.4%
Pruritusitching	47	1.4%
Injection site erythemaredness where the injection was given	46	1.3%
Oedemaswelling from fluid	46	1.3%
Heart rate increaseda fast heart rate reading	45	1.3%
Tremorshaking	44	1.3%
Injection site reactiona reaction where the injection was given	42	1.2%

Download all 285 terms of H P Acthar (CSV)

The counts add to more than 3,412 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name H P Acthar, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2006	3	3	0	0	2	0	0	1	0
2007	2	2	0	0	2	0	0	0	0
2009	8	8	1	0	7	0	0	0	0
2010	9	9	4	0	5	0	0	0	0
2011	2	2	0	0	2	0	0	0	0
2012	5	5	1	1	2	0	0	2	0
2013	7	7	1	0	7	1	0	1	0
2014	62	58	11	1	38	0	0	22	4
2015	808	161	31	4	105	2	0	55	647
2016	415	179	26	1	68	2	0	97	236
2017	573	229	33	0	84	1	1	133	344
2018	285	166	26	2	67	2	0	90	119
2019	372	228	34	1	75	1	0	140	144
2020	248	215	37	1	75	1	0	135	33
2021	238	226	30	3	83	3	0	144	12
2022	291	282	22	3	117	1	0	198	9
2023	68	62	5	0	27	0	0	39	6
2024	9	6	4	0	1	0	0	1	3
2025	5	5	3	0	1	0	0	1	0
2026	2	0	0	0	0	0	0	0	2

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name H P Acthar, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name H P Acthar, by the year in which FDA received them
Year	Reports
2006	1
2007	4
2009	4
2010	8
2011	7
2012	6
2013	7
2014	65
2015	815
2016	416
2017	577
2018	282
2019	379
2020	255
2021	252
2022	267
2023	51
2024	9
2025	5
2026	2

Reports that name H P Acthar, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name H P Acthar
Age	Reports	Share
Under 2	121	3.5%
2 to 11	12	0.4%
12 to 17	7	0.2%
18 to 44	362	10.6%
45 to 64	810	23.7%
65 to 74	370	10.8%
75 and over	158	4.6%
Age not given	1,572	46.1%

Sex of the patient in the reports that name H P Acthar
Sex	Reports	Share
Female	2,172	63.7%
Male	1,057	31%
Unknown or not given	183	5.4%

Type of reporter in the reports that name H P Acthar
Reporter	Reports	Share
Physician	275	8.1%
Pharmacist	558	16.4%
Other health professional	931	27.3%
Lawyer	0	0%
Consumer or non-health professional	1,487	43.6%
Not given	161	4.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 99.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of H P Acthar record
Indication as recorded (MedDRA)	Reports	Share
Multiple sclerosis	373	10.9%
Rheumatoid arthritis	334	9.8%
Nephrotic syndrome	261	7.6%
Sarcoidosis	195	5.7%
Systemic lupus erythematosus	160	4.7%
Proteinuria	111	3.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,412 reports.

Drugs in the same reports

Other drugs that the reports of H P Acthar name, in any role, in order of name
Drug	Reports that name the two
Baclofen	84
Ergocalciferol	89
Folic acid	91
Furosemide	101
Gabapentin	120
Lisinopril	129
Methotrexate	95
Omeprazole	103
Prednisone	315
Vitamin d	92

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for H P ActharThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. H P Acthar: adverse event reports that FDA received. https://reportedreactions.com/drug/h-p-acthar/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names H P Acthar as a suspect or interacting product. The 147 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that H P Acthar was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of H P Acthar?

No. It is a count of what people reported to FDA: 3,412 reports from August 2006 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (43.6%), other health professional (27.3%) and pharmacist (16.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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