Rogaine adverse event reports that FDA received

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

Name type: Product name as reported
Also reported as: Rogaine Unspecified

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.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 3,541 adverse event reports that name Rogaine. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 348 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 86 reports in the 12 months to June 2026 and 256 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 86 (under 0.1%) name Rogaine. Reports from consumers or other non-health professionals were 93.1% of the reports that name Rogaine and 45.8% of all drug reports.

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 Rogaine 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 29 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.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 18 reports that name Rogaine.
In January to March 2026, FDA received 26.
In April to June 2025, FDA received 58.

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 117 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 3,534 of the 3,541 reports (99.8%).

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 117 terms.

Reaction terms in the reports that name Rogaine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,541 reports
Drug ineffectivethe medicine did not work as expected	697	19.7%
Alopeciahair loss	608	17.2%
Product use in unapproved indicationused for a purpose not on the label	294	8.3%
Therapeutic response unexpected	185	5.2%
Pruritusitching	149	4.2%
Product administered at inappropriate site	148	4.2%
Hair texture abnormal	129	3.6%
Off label useused for a purpose or in a way not on the label	129	3.6%
Hair colour changes	115	3.2%
Hair growth abnormal	112	3.2%
Product use issuea problem in how the product was used	111	3.1%
Application site pruritusitching where the product was applied	103	2.9%
Headachehead pain	94	2.7%
Dizzinesslight-headedness or unsteadiness	93	2.6%
Drug administered at inappropriate site	64	1.8%
Inappropriate schedule of product administrationthe product was taken at the wrong times	61	1.7%
Wrong technique in product usage processthe product was used in the wrong way	60	1.7%
Application site pain	53	1.5%
Therapeutic product effect incomplete	48	1.4%
Heart rate increaseda fast heart rate reading	47	1.3%
Application site irritation	45	1.3%
Drug effect incomplete	44	1.2%
Incorrect dose administeredthe wrong dose was given	43	1.2%
Dandruff	41	1.2%
Dry skin	40	1.1%
Inappropriate schedule of drug administrationthe medicine was taken at the wrong times	40	1.1%
Chest pain	38	1.1%
Palpitationsawareness of the heartbeat	38	1.1%
Erythemaskin redness	37	1%
Rashskin rash	37	1%
Skin irritationirritated skin	37	1%
Adverse eventan unwanted medical event, type not specified	33	0.9%
Product formulation issue	32	0.9%
Application site erythemaredness where the product was applied	31	0.9%
Hypersensitivityan allergic-type reaction	31	0.9%
Application site rash	29	0.8%
Erectile dysfunctiondifficulty getting or keeping an erection	29	0.8%
Skin exfoliationpeeling skin	29	0.8%
Application site dryness	28	0.8%
Hair disorder	28	0.8%
Overdosea dose above the recommended amount	28	0.8%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	26	0.7%
Wrong drug administeredthe wrong medicine was given	26	0.7%
Blood pressure increaseda raised blood pressure reading	25	0.7%
Seborrhoea	25	0.7%
Skin disorder	25	0.7%
Accidental exposure to product	23	0.6%
Contraindicated product administered	22	0.6%
Intentional product misusedeliberate use not as intended	22	0.6%
Swelling facea swollen face	22	0.6%

Download all 117 terms of Rogaine (CSV)

The counts add to more than 3,541 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 Rogaine, 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
2004	61	59	2	0	22	1	1	35	2
2005	75	72	0	0	26	0	0	48	3
2006	56	54	0	2	10	0	0	46	2
2007	65	64	0	1	17	0	0	46	1
2008	49	47	0	0	4	1	0	42	2
2009	102	99	0	0	11	1	2	90	3
2010	60	58	1	0	6	0	0	53	2
2011	36	32	0	0	7	0	0	26	4
2012	19	19	1	1	4	1	1	17	0
2013	4	3	0	0	1	0	0	2	1
2014	0	0	0	0	0	0	0	0	0
2015	195	0	0	0	0	0	0	0	195
2016	208	5	0	0	0	1	0	5	203
2017	311	12	1	0	2	3	0	7	299
2018	373	45	0	2	6	3	0	37	328
2019	435	11	0	2	6	2	0	6	424
2020	308	3	0	1	0	0	0	2	305
2021	542	13	0	2	2	7	0	4	529
2022	132	4	0	0	1	0	0	4	128
2023	102	4	0	1	0	0	0	3	98
2024	166	7	1	0	1	2	0	6	159
2025	197	5	0	0	2	0	0	3	192
2026	45	3	0	0	1	0	0	2	42

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 Rogaine, 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 Rogaine, by the year in which FDA received them
Year	Reports
2004	58
2005	70
2006	59
2007	69
2008	47
2009	94
2010	66
2011	38
2012	24
2013	3
2015	196
2016	215
2017	315
2018	373
2019	424
2020	310
2021	544
2022	129
2023	101
2024	165
2025	197
2026	44

Reports that name Rogaine, 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 Rogaine
Age	Reports	Share
Under 2	6	0.2%
2 to 11	6	0.2%
12 to 17	9	0.3%
18 to 44	196	5.5%
45 to 64	200	5.6%
65 to 74	111	3.1%
75 and over	61	1.7%
Age not given	2,952	83.4%

Sex of the patient in the reports that name Rogaine
Sex	Reports	Share
Female	1,209	34.1%
Male	790	22.3%
Unknown or not given	1,542	43.5%

Type of reporter in the reports that name Rogaine
Reporter	Reports	Share
Physician	65	1.8%
Pharmacist	22	0.6%
Other health professional	84	2.4%
Lawyer	1	under 0.1%
Consumer or non-health professional	3,296	93.1%
Not given	73	2.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 92.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Rogaine record
Indication as recorded (MedDRA)	Reports	Share
Alopecia	820	23.2%
Hair growth abnormal	37	1%
Hypotrichosis	35	1%
Madarosis	18	0.5%
Accidental exposure to product	11	0.3%
Alopecia areata	10	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,541 reports.

Drugs in the same reports

Other drugs that the reports of Rogaine name, in any role, in order of name
Drug	Reports that name the two
Aspirin	22
Atenolol	14
Atorvastatin calcium	9
Calcium	16
Finasteride	15
Levothyroxine sodium	18
Lisinopril	12
Mens Rogaine Extra Strength	12
Minoxidil	13
Propecia	13

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 RogaineThe 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. Rogaine: adverse event reports that FDA received. https://reportedreactions.com/drug/rogaine/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 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 29 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 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Rogaine as a suspect or interacting product. The 348 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 Rogaine 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 Rogaine?

No. It is a count of what people reported to FDA: 3,541 reports from January 2004 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 (93.1%), other health professional (2.4%) and physician (1.8%). 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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