Hair colour changes adverse event reports that record this term

Kind of term: MedDRA preferred term

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 February 2004 to June 2026, FDA received 12,402 adverse event reports that record the MedDRA preferred term Hair colour changes. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 278 reports in the 12 months to June 2026 and 365 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

By reports in the 12 months to June 2026, this term was number 1,253 of 1,436 reaction terms with a page. Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 278 (under 0.1%) record this term. Reports for female patients were 76.1% of the reports that record this term and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate.

MedDRA

The Medical Dictionary for Regulatory Activities. The person who codes a report selects the preferred term that agrees best with the description of the reporter. FDA does not publish the description.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 145 drug pages with 5 or more reports that record this term. The rows are in order of name. A drug page with fewer reports for this term is not in the table. The counts are the counts that the site keeps for each reaction term, and a count can be lower than the count of FDA.

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.

Drugs that the reports with the term Hair colour changes name as a suspect product, in order of name
Drug	Class	Reports with this term
Adcirca	Phosphodiesterase 5 inhibitor	10
Adriamycin		18
Afinitor	Kinase inhibitor	7
Ambrisentan	Endothelin receptor antagonist	23
Amlodipine	Calcium channel blocker	8
Arimidex	Aromatase inhibitor	5
Aubagio	Pyrimidine synthesis inhibitor	11
Avapritinib	Kinase inhibitor	16
Ayvakit	Kinase inhibitor	361
Boniva		7
Bupropion hydrochloride	Aminoketone	8
Cabometyx	Kinase inhibitor	585
Cabozantinib	Kinase inhibitor	6
Carboplatin	Platinum-based drug	59
Ciprofloxacin	Fluoroquinolone antibacterial	19
Ciprofloxacin hydrochloride	Fluoroquinolone antibacterial	6
Clopidogrel	P2Y12 platelet inhibitor	6
Cometriq	Kinase inhibitor	78
Cosentyx	Interleukin-17A antagonist	8
Crestor	HMG-CoA reductase inhibitor	19
Cyclophosphamide	Alkylating drug	27
Cymbalta		8
Cytarabine	Nucleoside metabolic inhibitor	5
Cytoxan		50
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	6
Docefrez		398
Docetaxel	Microtubule inhibitor	5,872
Docetaxel Accord		232
Docetaxel Actavis		49
Docetaxel Hospira		67
Docetaxel Sandoz		392
Doxorubicin	Anthracycline topoisomerase inhibitor	10
Doxycycline	Tetracycline-class drug	13
Drug		5
Dupixent	Interleukin-4 receptor alpha antagonist	39
Eliquis	Factor Xa inhibitor	11
Enbrel	Tumor necrosis factor blocker	30
Entresto	Angiotensin 2 receptor blocker	6
Eskata		6
Femara	Aromatase inhibitor	7
Finasteride	5-alpha reductase inhibitor	5
Forteo	Parathyroid hormone analog	45
Furosemide	Loop diuretic	21
Gilenya	Sphingosine 1-phosphate receptor modulator	9
Gleevec	Kinase inhibitor	6
Glivec		5
Herceptin	HER2/neu receptor antagonist	67
Humira		35
Ibrance	Kinase inhibitor	27
Imbruvica	Kinase inhibitor	9
Inlyta	Kinase inhibitor	9
Ipilimumab	CTLA-4-directed blocking antibody	5
Ketoconazole	Azole antifungal	52
Keytruda	Programmed death Receptor-1 blocking antibody	21
Kisqali	Kinase inhibitor	9
Klonopin	Benzodiazepine	7
Koselugo	Kinase inhibitor	14
Lamictal	Anti-epileptic agent	6
Lasix	Loop diuretic	6
Latisse	Prostaglandin analog	6
Letrozole	Aromatase inhibitor	6
Levothyroxine		8
Litfulo	Kinase inhibitor	8
Losartan	Angiotensin 2 receptor blocker	5
Lurasidone hydrochloride	Atypical antipsychotic	10
Lyrica		5
Mekinist	Kinase inhibitor	6
Mens Rogaine		24
Mens Rogaine Extra Strength		267
Mens Rogaine Extra Strength Unscented	Arteriolar vasodilator	6
Metformin	Biguanide	15
Methotrexate	Folate analog metabolic inhibitor	9
Methotrexate sodium	Folate analog metabolic inhibitor	5
Minocycline	Tetracycline-class drug	13
Minoxidil	Arteriolar vasodilator	252
Mirena	Progestin	10
Neulasta	Leukocyte growth factor	16
Nitrofurantoin	Nitrofuran antibacterial	14
Nivolumab	Programmed death Receptor-1 blocking antibody	37
Nizoral	Azole antifungal	16
Nizoral A-D		19
Novothyrox		6
Ocrevus	CD20-directed cytolytic antibody	9
Ojemda	Kinase inhibitor	18
Olanzapine	Atypical antipsychotic	6
Olumiant	Janus kinase inhibitor	5
Omeprazole	Proton pump inhibitor	29
Ondansetron	Serotonin-3 receptor antagonist	11
Opdivo	Programmed death Receptor-1 blocking antibody	50
Otezla	Phosphodiesterase 4 inhibitor	7
Ozempic	GLP-1 receptor agonist	12
Paclitaxel	Microtubule inhibitor	6
Paraplatin		21
Pazopanib	Kinase inhibitor	53
Pegasys	Interferon alpha	8
Perjeta	HER2/neu receptor antagonist	22
Pertuzumab	HER2/neu receptor antagonist	16
Pexidartinib		101
Plaquenil	Antimalarial	5
Prednisone	Corticosteroid	21
Prolia	RANK ligand inhibitor	12
Propecia	5-alpha reductase inhibitor	16
Qinlock	Kinase inhibitor	16
Ramipril	Angiotensin converting enzyme inhibitor	19
Revlimid	Thalidomide analog	22
Ribavirin	Nucleoside analog antiviral	13
Rogaine		115
Sandostatin	Somatostatin analog	6
Sandostatin LAR Depot		6
Selumetinib	Kinase inhibitor	7
Seroquel	Atypical antipsychotic	21
Sertraline	Serotonin reuptake inhibitor	12
Spironolactone	Aldosterone antagonist	27
Sprycel	Kinase inhibitor	11
Strattera	Norepinephrine reuptake inhibitor	6
Sunitinib		6
Sutent	Kinase inhibitor	455
Synthroid	l-Thyroxine	9
Tadalafil	Phosphodiesterase 5 inhibitor	12
Tarceva		21
Tasigna	Kinase inhibitor	7
Taxol		8
Taxotere		2,649
Tramadol		6
Tramadol hydrochloride	Opioid agonist	5
Trametinib	Kinase inhibitor	9
Trastuzumab	HER2/neu receptor antagonist	14
Turalio	Kinase inhibitor	235
Tymlos		5
Tysabri	Integrin receptor antagonist	14
Venclexta	BCL-2 inhibitor	10
Vincristine		7
Vortioxetine		10
Votrient	Kinase inhibitor	783
Wellbutrin	Aminoketone	8
Womens Rogaine		160
Womens Rogaine Unscented	Arteriolar vasodilator	445
Xalatan	Prostaglandin analog	10
Xarelto	Factor Xa inhibitor	6
Xeljanz	Janus kinase inhibitor	9
Xeloda	Nucleoside metabolic inhibitor	7
Xolair	Anti-IgE	16
Yervoy	CTLA-4-directed blocking antibody	15
Zelboraf	Kinase inhibitor	7
Zetia	Dietary cholesterol absorption inhibitor	7

The page of each drug has the count of each reaction term in its reaction lookup.

Drug classes in these reports

The table has the 51 pharmacologic classes with 10 or more reports that record this term. The rows are in order of name.

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.

Pharmacologic classes of the drugs that the reports with the term Hair colour changes name, in order of name
Class	Reports with this term
5-alpha reductase inhibitor	25
Aldosterone antagonist	27
Alkylating drug	32
Aminoketone	18
Angiotensin 2 receptor blocker	17
Angiotensin converting enzyme inhibitor	21
Anthracycline topoisomerase inhibitor	10
Anti-epileptic agent	15
Anti-IgE	18
Aromatase inhibitor	22
Arteriolar vasodilator	697
Atypical antipsychotic	41
Azole antifungal	68
BCL-2 inhibitor	10
Biguanide	18
CD20-directed cytolytic antibody	11
Corticosteroid	25
CTLA-4-directed blocking antibody	20
Endothelin receptor antagonist	25
Factor Xa inhibitor	17
Fluoroquinolone antibacterial	28
Folate analog metabolic inhibitor	14
GLP-1 receptor agonist	20
HER2/neu receptor antagonist	119
HMG-CoA reductase inhibitor	23
Integrin receptor antagonist	14
Interleukin-4 receptor alpha antagonist	39
Janus kinase inhibitor	21
Kinase inhibitor	2,761
l-Thyroxine	11
Leukocyte growth factor	16
Loop diuretic	27
Microtubule inhibitor	5,878
Nitrofuran antibacterial	14
Nucleoside analog antiviral	13
Nucleoside metabolic inhibitor	16
Opioid agonist	12
Parathyroid hormone analog	45
Phosphodiesterase 5 inhibitor	22
Platinum-based drug	61
Progestin	10
Programmed death Receptor-1 blocking antibody	114
Prostaglandin analog	19
Proton pump inhibitor	36
Pyrimidine synthesis inhibitor	13
RANK ligand inhibitor	14
Serotonin reuptake inhibitor	16
Serotonin-3 receptor antagonist	13
Tetracycline-class drug	28
Thalidomide analog	24
Tumor necrosis factor blocker	34

A class with many reports in all has many reports for almost every term.

Reports by month

Reports that record Hair colour changes, 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.

Patients in these reports

Age of the patient in the reports that record Hair colour changes
Age	Reports	Share
Under 2	6	under 0.1%
2 to 11	63	0.5%
12 to 17	75	0.6%
18 to 44	1,660	13.4%
45 to 64	5,269	42.5%
65 to 74	1,634	13.2%
75 and over	574	4.6%
Age not given	3,121	25.2%

Sex of the patient in the reports that record Hair colour changes
Sex	Reports	Share
Female	9,443	76.1%
Male	2,428	19.6%
Unknown or not given	531	4.3%

Age and sex are as the report gives them. 91% of these reports give the United States as the country.

Terms near this one

These are the next terms in the A to Z list. The links are for navigation.

Official pages

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. Hair colour changes: adverse event reports that record this term. https://reportedreactions.com/reaction/hair-colour-changes/ 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.

The count has the reports with each spelling of one MedDRA preferred term. 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

What does Hair colour changes mean in an adverse event report?

It is a MedDRA preferred term. FDA codes the description of a reporter with the MedDRA dictionary. The openFDA files do not have the description itself, and this site does not show it.

Does a drug in the table mean that the drug was responsible for this reaction?

No. FDA says:

No individual drug is connected to any individual reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.

What does this page tell a person who has this symptom?

This page gives counts of reports. It cannot assess a person. A pharmacist or a clinician can assess a person.

If this is a medical emergency, please call 911.
Source: FDA, MedWatch Online Voluntary Reporting Form. The site read the page on 2 Oct 2026.

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