MedDRA preferred term

Product formulation issue: adverse event reports recording this term

6,522 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.

6,522
reports recording the term: 0% of all reports; 258
reports, 12 months to June 2026: 389 in the 12 months before; 43.8%
marked serious by the reporter: 57.4% across all reports; 0.4%
record death among outcomes, as reported: 9.1% across all reports

6,522 reports in FDA's adverse event database record the MedDRA term "Product formulation issue": 0% of all reports received between April 2009 and June 2026. Coders pick the term that best matches the reporter's description.

258 reports recorded it in the 12 months to June 2026, down 34% from 389 in 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, 43.8% are marked serious, 0.4% include death among the outcomes and 5.9% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Womens Rogaine Unscented, Novothyrox and Mens Rogaine Extra Strength. 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
Womens Rogaine Unscented	Arteriolar vasodilator	714	6.3%
Novothyrox	—	622	5.9%
Mens Rogaine Extra Strength	—	463	3.7%
OxyContin	Opioid agonist	210	0.1%
Minoxidil	Arteriolar vasodilator	84	0.3%
Dextroamphet Saccharat Amphet Aspartate Dextroamphet Sulfate and Amphet Sulfat	—	67	1.7%
Womens Rogaine	—	60	1.2%
Dextroamphet Saccharat Amphet Aspartate Dextroamphet Sulfate and Amp	—	58	1.8%
Synthroid	l-Thyroxine	56	0.2%
Omeprazole	Proton pump inhibitor	48	0.1%
Oxycodone hydrochloride	Opioid agonist	44	0%
Imodium Multi-Symptom Relief	—	39	0.7%
Levothyroxine sodium	l-Thyroxine	38	0.3%
Adderall	Central nervous system stimulant	33	0.3%
Rogaine	—	32	0.9%
Vyvanse	Central nervous system stimulant	29	0.2%
Advil	Nonsteroidal anti-inflammatory drug	27	0.1%
Thyroid	—	27	6.4%
Clonazepam	Benzodiazepine	25	0.1%
Methylphenidate	Central nervous system stimulant	25	0.4%
Alprazolam	Benzodiazepine	24	0%
Bupropion hydrochloride	Aminoketone	23	0.1%
Xalatan	Prostaglandin analog	23	0.3%
Humira	—	22	0%
Dextroamphetamine Saccharate Amphetamine Aspartate Dextroamphetamine	—	21	0.8%

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
Arteriolar vasodilator	798	1.8%	0.2%
Opioid agonist	342	0%	0%
Central nervous system stimulant	139	0.1%	0%
l-Thyroxine	132	0.3%	0.3%
Benzodiazepine	69	0%	0%
Proton pump inhibitor	60	0%	0%
Nonsteroidal anti-inflammatory drug	59	0%	0%
Prostaglandin analog	45	0.1%	0%
Serotonin and norepinephrine reuptake inhibitor	40	0%	0%
Histamine-1 receptor antagonist	39	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 21.6%104

2 to 111.8%118

12 to 170.9%60

18 to 4415.7%1,026

45 to 6422.9%1,492

65 to 7411.5%751

75 and over5.7%373

Age not given39.8%2,598

Patient sex

Female61.2%3,989

Male24.9%1,621

Not given14%912

Grey bar: all 20,646,523 reports in the database. 82.7% of these reports give the United States as the country.

Questions about "Product formulation issue"

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

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 formulation issue?

6,522 reports through June 2026 (0% of all reports), 258 of them in the latest 12 months.

Which drugs appear most often in these reports?

Womens Rogaine Unscented (714), Novothyrox (622), Mens Rogaine Extra Strength (463), OxyContin (210) and Minoxidil (84). 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.