MedDRA preferred term

Product physical consistency issue: adverse event reports recording this term

5,397 reports to FDA record it, 2011–2026; 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.

5,397
reports recording the term: 0% of all reports; 521
reports, 12 months to June 2026: 585 in the 12 months before; 10%
marked serious by the reporter: 57.4% across all reports; 0.3%
record death among outcomes, as reported: 9.1% across all reports

5,397 reports in FDA's adverse event database record the MedDRA term "Product physical consistency issue": 0% of all reports received between February 2011 and June 2026. Coders pick the term that best matches the reporter's description.

521 reports recorded it in the 12 months to June 2026, down 11% from 585 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, 10% are marked serious, 0.3% include death among the outcomes and 1.7% include hospitalisation, as reported.

The drugs listed most often as suspect products in those reports are Eligard, Winlevi and Buprenorphine. 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
Eligard	Gonadotropin releasing hormone receptor agonist	920	2.1%
Winlevi	Androgen receptor inhibitor	328	24.5%
Buprenorphine	Partial opioid agonist	182	0.9%
Cholestyramine	—	137	8.4%
Opzelura	Janus kinase inhibitor	122	3.7%
Device	—	109	2.2%
Aleve	Nonsteroidal anti-inflammatory drug	101	0.2%
Testosterone	Androgen	93	1.3%
Vivitrol	—	86	0.3%
Womens Rogaine Unscented	Arteriolar vasodilator	81	0.7%
MiraLAX	Osmotic laxative	78	0.2%
Mens Rogaine Extra Strength	—	77	0.6%
Aristada	Atypical antipsychotic	65	1.5%
Belbuca	Partial opioid agonist	59	1.9%
Clobetasol propionate	Corticosteroid	43	1.7%
Veltassa	—	39	0.3%
Pataday Once Daily Relief	Histamine-1 receptor antagonist	36	3.6%
Estradiol	Estrogen	32	0.2%
Restasis	Calcineurin inhibitor immunosuppressant	30	0.2%
Azelaic acid	—	29	10.4%
Fensolvi	Gonadotropin releasing hormone receptor agonist	29	3.9%
Ilevro	Nonsteroidal anti-inflammatory drug	26	2.5%
Triamcinolone acetonide	Corticosteroid	26	0.3%
Diclofenac sodium	Nonsteroidal anti-inflammatory drug	25	0%
Genotropin	—	25	0.1%

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
Gonadotropin releasing hormone receptor agonist	949	1.5%	0%
Androgen receptor inhibitor	331	0.5%	0%
Partial opioid agonist	247	0.3%	0%
Nonsteroidal anti-inflammatory drug	205	0%	0%
Corticosteroid	127	0%	0%
Janus kinase inhibitor	122	0%	0%
Androgen	106	0.5%	0.1%
Arteriolar vasodilator	83	0.2%	0%
Osmotic laxative	81	0.1%	0%
Estrogen	69	0.1%	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%27

2 to 111.9%100

12 to 170.8%42

18 to 446.8%367

45 to 6411.8%639

65 to 7410.9%587

75 and over10.2%549

Age not given57.2%3,086

Patient sex

Female44.1%2,382

Male33.1%1,789

Not given22.7%1,226

Grey bar: all 20,646,523 reports in the database. 85.4% of these reports give the United States as the country.

Questions about "Product physical consistency issue"

What does "Product physical consistency 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 physical consistency issue?

5,397 reports through June 2026 (0% of all reports), 521 of them in the latest 12 months.

Which drugs appear most often in these reports?

Eligard (920), Winlevi (328), Buprenorphine (182), Cholestyramine (137) and Opzelura (122). 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.