Minoxidil
According to the FDA label: Because of the potential for serious adverse effects, minoxidil tablets are indicated only in the treatment of hypertension that is symptomatic or associated with target organ damage and is not manageable with maximum therapeutic doses of a diuretic plus two other antihypertensive drugs. At the present time use in milder degrees of hypertension is not recommended because the benefit-risk relationship in such patients has not been defined.
32,254 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Minoxidil 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
Tap any term below for a plain-language definition.
Adverse Drug Reaction 8,500 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 6,173 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 →Application Site Pruritus 2,521 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 1,425 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 →Application Site Irritation 1,212 reports
Irritation of the skin where a medication was applied, such as under a patch or cream.
Full definition in the glossary →Application Site Pain 1,078 reports
Pain at the spot where a medication was applied, such as under a patch.
Full definition in the glossary →Headache 1,061 reports
Pain in the head or upper neck.
Full definition in the glossary → See all drugs reporting this event →Alopecia 854 reports
- Application Site Dryness 731 reports
Inappropriate Schedule of Product Administration 728 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 →Condition Aggravated 696 reports
A report that the person's existing health condition got worse. This describes a worsening of something the person already had, not necessarily a new problem caused by the drug.
Full definition in the glossary →Rash 639 reports
An area of irritated, red, or bumpy skin.
Full definition in the glossary → See all drugs reporting this event →Dizziness 613 reports
A feeling of being lightheaded, unsteady, or like the room is spinning.
Full definition in the glossary → See all drugs reporting this event →- Product Administered At Inappropriate Site 613 reports
Hypersensitivity 596 reports
An exaggerated reaction by the immune system, similar to an allergic reaction.
Full definition in the glossary →
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 | 23,580 |
| Female | 7,084 |
| Unknown | 13 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 304 |
| 18-34 | 976 |
| 35-49 | 1,372 |
| 50-64 | 2,090 |
| 65-74 | 1,671 |
| 75+ | 1,051 |
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 Minoxidil. 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 | 27,840 |
| Other Serious | 2,884 |
| Hospitalization | 2,002 |
| Death | 445 |
| Disability | 265 |
| Life-Threatening | 240 |
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 Minoxidil. 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 | 127 |
| 2007 | 89 |
| 2008 | 113 |
| 2009 | 130 |
| 2010 | 149 |
| 2011 | 167 |
| 2012 | 219 |
| 2013 | 152 |
| 2014 | 196 |
| 2015 | 588 |
| 2016 | 828 |
| 2017 | 794 |
| 2018 | 967 |
| 2019 | 981 |
| 2020 | 2,456 |
| 2021 | 4,838 |
| 2022 | 7,986 |
| 2023 | 5,654 |
| 2024 | 3,109 |
| 2025 | 2,219 |
| 2026 (partial) | 275 |
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 Minoxidil
In FDA adverse event reports that mention Minoxidil, these medications appeared most often in the same report.
- Furosemide (1,071 reports)
- Aspirin (899 reports)
- Finasteride (867 reports)
- Metoprolol (840 reports)
- Omeprazole (835 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