Rogaineminoxidil
According to the FDA label: Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
44,060 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Rogaine in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
Show these terms with plain-language definitions
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Adverse Drug Reaction 8,512 reports
A general report of a harmful or unintended response to a medication, used when no more specific reaction is named.
Full definition in the glossary →Drug Ineffective 7,707 reports
A report that the medication did not work as expected for the person taking it. This is a reporting category, not a sign the drug is defective. It simply means someone felt it was not helping their condition.
Full definition in the glossary →Alopecia 3,766 reports
Application Site Pruritus 2,909 reports
Itching of the skin where a medication was applied, such as under a patch or cream. Pruritus means itching.
Full definition in the glossary →Off Label Use 2,247 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Overdose 1,445 reports
Taking more of a medication than intended or recommended. This can be accidental.
Full definition in the glossary →Application Site Irritation 1,401 reports
Irritation of the skin where a medication was applied, such as under a patch or cream.
Full definition in the glossary →Hair Texture Abnormal 1,397 reports
A change in the feel or quality of the hair, such as becoming brittle or coarse.
Full definition in the glossary →Application Site Pain 1,394 reports
Pain at the spot where a medication was applied, such as under a patch.
Full definition in the glossary →Headache 1,319 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Incorrect Dose Administered 1,289 reports
A report that the wrong dose was given or taken. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Product Use in Unapproved Indication 1,173 reports
Using a medication for a condition it is not officially approved to treat. Like off label use, this is a reporting category and does not by itself mean harm occurred.
Full definition in the glossary →Inappropriate Schedule of Product Administration 1,167 reports
A report that the medication was taken on the wrong schedule, such as too often, not often enough, or at the wrong time. This is a usage category, not a sign of a problem with the drug.
Full definition in the glossary →Wrong Technique in Product Usage Process 1,150 reports
A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →Pruritus 1,001 reports
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 23,919 |
| Female | 16,894 |
| Unknown | 13 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 783 |
| 18-34 | 1,274 |
| 35-49 | 2,003 |
| 50-64 | 3,467 |
| 65-74 | 3,064 |
| 75+ | 1,856 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Rogaine. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 39,493 |
| Other Serious | 2,983 |
| Hospitalization | 2,037 |
| Death | 446 |
| Disability | 285 |
| Life-Threatening | 249 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Rogaine. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 95 |
| 2005 | 122 |
| 2006 | 129 |
| 2007 | 89 |
| 2008 | 113 |
| 2009 | 131 |
| 2010 | 152 |
| 2011 | 176 |
| 2012 | 225 |
| 2013 | 152 |
| 2014 | 198 |
| 2015 | 2,018 |
| 2016 | 2,765 |
| 2017 | 2,724 |
| 2018 | 2,452 |
| 2019 | 2,280 |
| 2020 | 3,227 |
| 2021 | 5,598 |
| 2022 | 8,466 |
| 2023 | 6,208 |
| 2024 | 3,687 |
| 2025 | 2,669 |
| 2026 (partial) | 384 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Rogaine
In FDA adverse event reports that mention Rogaine, these medications appeared most often in the same report.
- Ergocalciferol (1,131 reports)
- Furosemide (1,089 reports)
- Aspirin (982 reports)
- Metoprolol (927 reports)
- Omeprazole (926 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026