Chromaturia 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 January 2004 to June 2026, FDA received 22,199 adverse event reports that record the MedDRA preferred term Chromaturia. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 1,136 reports in the 12 months to June 2026 and 1,008 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.

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 1 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 108 drug pages with 50 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 Chromaturia name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		79
Acetylsalicylic Acid		50
Actemra	Interleukin-6 receptor antagonist	53
Alemtuzumab	CD52-directed cytolytic antibody	67
Aleve	Nonsteroidal anti-inflammatory drug	62
Alinia		52
Alli	Intestinal lipase inhibitor	97
Amlodipine	Calcium channel blocker	86
Amoxicillin	Penicillin-class antibacterial	107
Ampyra	Potassium channel blocker	105
Aspirin	Nonsteroidal anti-inflammatory drug	107
Atorvastatin		332
Atorvastatin calcium	HMG-CoA reductase inhibitor	78
Aubagio	Pyrimidine synthesis inhibitor	85
Augmentin	Penicillin-class antibacterial	52
Augmentin '125		65
Avonex	Interferon beta	57
Brilinta	P2Y12 platelet inhibitor	54
Cabometyx	Kinase inhibitor	52
Carboplatin	Platinum-based drug	63
Ciprofloxacin	Fluoroquinolone antibacterial	108
Clarithromycin	Macrolide antimicrobial	157
Cosentyx	Interleukin-17A antagonist	98
Crestor	HMG-CoA reductase inhibitor	344
Cyclophosphamide	Alkylating drug	53
Cymbalta	Serotonin and norepinephrine reuptake inhibitor	167
Dexamethasone	Corticosteroid	72
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	66
Doxycycline	Tetracycline-class drug	61
Dupixent	Interleukin-4 receptor alpha antagonist	98
Eliquis	Factor Xa inhibitor	206
Enbrel	Tumor necrosis factor blocker	171
Entresto	Angiotensin 2 receptor blocker	73
Esbriet	Pyridone	111
Exjade	Iron chelator	115
Ezetimibe	Dietary cholesterol absorption inhibitor	55
Filspari	Angiotensin 2 receptor blocker	73
Forteo	Parathyroid hormone analog	110
Gabapentin	Anti-epileptic agent	55
Gilenya	Sphingosine 1-phosphate receptor modulator	163
Humira		374
Ibrance	Kinase inhibitor	61
Ibuprofen	Nonsteroidal anti-inflammatory drug	182
Imbruvica	Kinase inhibitor	91
Jardiance	Sodium-Glucose cotransporter 2 inhibitor	51
Ketek		71
Kisqali	Kinase inhibitor	104
Lamisil		73
Lansoprazole	Proton pump inhibitor	93
Letrozole	Aromatase inhibitor	69
Levofloxacin	Fluoroquinolone antibacterial	59
Lialda	Aminosalicylate	70
Lipitor	HMG-CoA reductase inhibitor	274
Lisinopril	Angiotensin converting enzyme inhibitor	59
Lyrica		77
Mavyret	Hepatitis C virus NS3/4A protease inhibitor	75
Metformin	Biguanide	55
Methotrexate	Folate analog metabolic inhibitor	102
Metoprolol	beta-Adrenergic blocker	54
Metronidazole	Nitroimidazole antimicrobial	310
Mounjaro	GLP-1 receptor agonist	67
Myrbetriq	beta3-Adrenergic agonist	86
Nexavar	Kinase inhibitor	54
Nexium	Proton pump inhibitor	92
Nitrofurantoin (monohydrate/macrocrystals)	Nitrofuran antibacterial	75
Nivolumab	Programmed death Receptor-1 blocking antibody	60
Ocaliva		50
Ofev	Kinase inhibitor	162
Omeprazole	Proton pump inhibitor	229
Opsumit	Endothelin receptor antagonist	62
Ozempic	GLP-1 receptor agonist	69
Pantoprazole	Proton pump inhibitor	77
Paxlovid		114
Pegasys	Interferon alpha	148
Plavix	P2Y12 platelet inhibitor	62
Pradaxa	Direct thrombin inhibitor	120
Pravastatin		57
Prednisone	Corticosteroid	93
Propofol	General anesthetic	57
Ramipril	Angiotensin converting enzyme inhibitor	63
Ranexa		66
Repatha	PCSK9 inhibitor	78
Revlimid	Thalidomide analog	207
Ribavirin	Nucleoside analog antiviral	173
Rinvoq	Janus kinase inhibitor	55
Rituximab	CD20-directed cytolytic antibody	50
Rosuvastatin	HMG-CoA reductase inhibitor	118
Sandostatin LAR Depot		63
Simvastatin	HMG-CoA reductase inhibitor	281
Soliris	Complement inhibitor	947
Stivarga	Kinase inhibitor	72
Strattera	Norepinephrine reuptake inhibitor	68
Sutent	Kinase inhibitor	207
Tamiflu	Neuraminidase inhibitor	55
Tecfidera		298
Terbinafine	Allylamine antifungal	58
Trulicity	GLP-1 receptor agonist	54
Truvada	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	56
Tysabri	Integrin receptor antagonist	132
Ultomiris	Complement inhibitor	53
Viekira Pak		185
Vivitrol		104
Votrient	Kinase inhibitor	69
Vumerity		74
Xarelto	Factor Xa inhibitor	380
Xeljanz	Janus kinase inhibitor	115
Xtandi	Androgen receptor inhibitor	68
Zocor	HMG-CoA reductase inhibitor	68

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 52 pharmacologic classes with 100 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 Chromaturia name, in order of name
Class	Reports with this term
Aminosalicylate	112
Angiotensin 2 receptor blocker	301
Angiotensin converting enzyme inhibitor	148
Anti-epileptic agent	158
Aromatase inhibitor	111
Atypical antipsychotic	183
beta-Adrenergic blocker	114
Calcium channel blocker	102
CD20-directed cytolytic antibody	122
Complement inhibitor	1,037
Corticosteroid	313
Dietary cholesterol absorption inhibitor	102
Direct thrombin inhibitor	120
Endothelin receptor antagonist	168
Factor Xa inhibitor	660
Fluoroquinolone antibacterial	188
Folate analog metabolic inhibitor	141
GLP-1 receptor agonist	311
HMG-CoA reductase inhibitor	1,229
Human immunoglobulin G	100
Integrin receptor antagonist	169
Interferon alpha	151
Interferon beta	103
Interleukin-17A antagonist	102
Interleukin-4 receptor alpha antagonist	104
Intestinal lipase inhibitor	101
Iron chelator	189
Janus kinase inhibitor	221
Kinase inhibitor	1,269
Macrolide antimicrobial	231
Nitroimidazole antimicrobial	366
Nonsteroidal anti-inflammatory drug	594
Nucleoside analog antiviral	193
Nucleoside metabolic inhibitor	152
Opioid agonist	215
P2Y12 platelet inhibitor	200
Parathyroid hormone analog	112
PCSK9 inhibitor	123
Penicillin-class antibacterial	164
Peroxisome proliferator receptor alpha agonist	100
Platinum-based drug	115
Potassium channel blocker	110
Programmed death Receptor-1 blocking antibody	144
Proton pump inhibitor	699
Pyridone	111
Pyrimidine synthesis inhibitor	115
Serotonin and norepinephrine reuptake inhibitor	213
Serotonin reuptake inhibitor	142
Sodium-Glucose cotransporter 2 inhibitor	123
Sphingosine 1-phosphate receptor modulator	201
Thalidomide analog	255
Tumor necrosis factor blocker	320

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

Reports by month

Reports that record Chromaturia, 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 Chromaturia
Age	Reports	Share
Under 2	56	0.3%
2 to 11	276	1.2%
12 to 17	263	1.2%
18 to 44	3,000	13.5%
45 to 64	5,686	25.6%
65 to 74	3,129	14.1%
75 and over	2,562	11.5%
Age not given	7,227	32.6%

Sex of the patient in the reports that record Chromaturia
Sex	Reports	Share
Female	11,290	50.9%
Male	9,228	41.6%
Unknown or not given	1,681	7.6%

Age and sex are as the report gives them. 62.4% 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. Chromaturia: adverse event reports that record this term. https://reportedreactions.com/reaction/chromaturia/ 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.

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 Chromaturia 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.

To the top of the page