MedDRA preferred term · the product was an odd colour

Product colour issue: adverse event reports recording this term

5,001 reports to FDA record it, 2009–2026; 0% of the database.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

5,001
reports recording the term: 0% of all reports; 515
reports, 12 months to June 2026: 477 in the 12 months before; 25.1%
marked serious by the reporter: 57.4% across all reports; 0.7%
record death among outcomes, as reported: 9.1% across all reports

5,001 reports in FDA's adverse event database record the MedDRA term "Product colour issue" (in plain words, the product was an odd colour): 0% of all reports received between April 2009 and June 2026. Coders pick the term that best matches the reporter's description.

515 reports recorded it in the 12 months to June 2026, close to the 477 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Of reports recording this term, 25.1% are marked serious, 0.7% include death among the outcomes and 7% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Vascepa, Veltassa and Synthroid. That order mostly follows how many reports each drug has overall; the table also gives the term's share within each drug's own reports. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Drugs listed as suspect products in these reports

Drug	Class	Reports with this term	Share of the drug's own reports
Vascepa	—	212	5.1%
Veltassa	—	101	0.8%
Synthroid	l-Thyroxine	90	0.3%
Eligard	Gonadotropin releasing hormone receptor agonist	69	0.2%
Advil	Nonsteroidal anti-inflammatory drug	65	0.3%
Epinephrine	Catecholamine	61	0.6%
Epipen	Catecholamine	55	1.5%
Nuvaring	Estrogen	51	0.3%
Restasis	Calcineurin inhibitor immunosuppressant	42	0.2%
Omeprazole	Proton pump inhibitor	41	0.1%
Humira	—	39	0%
Buprenorphine	Partial opioid agonist	36	0.2%
Dextroamphet Saccharat Amphet Aspartate Dextroamphet Sulfate and Amp	—	33	1%
Alprazolam	Benzodiazepine	31	0.1%
Eliquis	Factor Xa inhibitor	31	0%
Xarelto	Factor Xa inhibitor	29	0%
Myrbetriq	beta3-Adrenergic agonist	28	0.1%
Ritalin	Central nervous system stimulant	28	0.5%
Testosterone cypionate	Androgen	26	0.8%
Amoxicillin Clavulanate Potassium	—	25	0.7%
Oxycodone hydrochloride	Opioid agonist	25	0%
Butrans	Partial opioid agonist	23	0%
Mens Rogaine Extra Strength	—	23	0.2%
Lyrica	—	22	0%
Paxlovid	—	22	0%

Drugs with a page on this site, ordered by the number of their reports recording this term. The last column is the term's share within that drug's own reports, against 0% across the whole database. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

By pharmacologic class

Class	Reports with this term	Share of class reports	Median drug in class
Catecholamine	127	0.6%	0.6%
l-Thyroxine	121	0.2%	0.2%
Nonsteroidal anti-inflammatory drug	120	0%	0%
Estrogen	107	0.1%	0%
Central nervous system stimulant	90	0.1%	0%
Opioid agonist	76	0%	0%
Benzodiazepine	75	0%	0%
Gonadotropin releasing hormone receptor agonist	69	0.1%	0%
Partial opioid agonist	66	0.1%	0%
Proton pump inhibitor	65	0%	0%

Classes ordered by count. Class shares follow the class's overall report volume as much as anything else.

Patients in these reports

Patient age

Under 20.5%23

2 to 112.4%119

12 to 171%48

18 to 447.5%374

45 to 6414.7%733

65 to 7410.6%529

75 and over9.1%453

Age not given54.4%2,722

Patient sex

Female51.8%2,589

Male30.6%1,531

Not given17.6%881

Grey bar: all 20,646,523 reports in the database. 87.8% of these reports give the United States as the country.

Questions about "Product colour issue"

What does "Product colour issue" mean in an adverse event report?

In plain language: the product was an odd colour. It is a MedDRA preferred term, the dictionary FDA uses to code what a reporter described. The report's own description is not published by openFDA and is not shown here.

How many reports record product colour issue?

5,001 reports through June 2026 (0% of all reports), 515 of them in the latest 12 months.

Which drugs appear most often in these reports?

Vascepa (212), Veltassa (101), Synthroid (90), Eligard (69) and Advil (65). Drugs with many reports overall lead almost every term's list. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Does a drug appearing here mean it was responsible for this reaction?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

I have this symptom. What should I do?

This site cannot assess anyone. A pharmacist or clinician can; for an emergency, call the local emergency number. Nothing on this page is medical advice.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. Terms are pooled across spelling and capitalisation variants of one MedDRA preferred term. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.