Product size issue 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 April 2009 to June 2026, FDA received 5,247 adverse event reports that record the MedDRA preferred term Product size issue. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 396 reports in the 12 months to June 2026 and 384 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 1,108 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, 396 (under 0.1%) record this term. Reports for patients 75 and over were 19.4% of the reports that record this term and 9.5% 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 124 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 Product size issue name as a suspect product, in order of name
Drug	Class	Reports with this term
Acetaminophen		10
Adapalene	Retinoid	7
Advil	Nonsteroidal anti-inflammatory drug	71
Advil Cold And Sinus	Nonsteroidal anti-inflammatory drug	6
Advil Liqui-Gels	Nonsteroidal anti-inflammatory drug	10
Advil pm	Nonsteroidal anti-inflammatory drug	34
Albuterol sulfate	beta2-Adrenergic agonist	11
Aleve	Nonsteroidal anti-inflammatory drug	42
Allegra Allergy	Histamine-1 receptor antagonist	15
Alprazolam	Benzodiazepine	10
Amlodipine	Calcium channel blocker	18
Amlodipine besylate	Dihydropyridine calcium channel blocker	10
Amoxicillin	Penicillin-class antibacterial	5
Amoxicillin Clavulanate Potassium		11
Armour Thyroid		25
Atorvastatin calcium	HMG-CoA reductase inhibitor	15
Belbuca	Partial opioid agonist	11
Braftovi		7
Buprenorphine	Partial opioid agonist	36
Celecoxib	Nonsteroidal anti-inflammatory drug	12
Claritin		9
Clonidine	Central alpha-2 adrenergic agonist	7
Colestid		7
Colestipol hydrochloride		29
Creon		32
Daratumumab Hyaluronidase-Fihj		6
Daybue		38
Desloratadine	Histamine-1 receptor antagonist	9
Dexamethasone	Corticosteroid	5
Dextroamphet Saccharat Amphet Aspartate Dextroamphet Sulfate and Amp		6
Dextroamphet Saccharat Amphet Aspartate Dextroamphet Sulfate and Amphet Sulfat		5
Dextromethorphan, guaifenesin	Expectorant	29
Duragesic		6
Eliquis	Factor Xa inhibitor	8
Enzalutamide	Androgen receptor inhibitor	81
Epclusa	Hepatitis C virus NS5A inhibitor	6
Epilim		5
Erleada		18
Escitalopram	Serotonin reuptake inhibitor	6
Esomeprazole	Proton pump inhibitor	9
Estradiol	Estrogen	28
Estradiol Transdermal System	Estrogen	65
Estring	Estrogen	31
Famotidine	Histamine-2 receptor antagonist	8
Fentanyl Transdermal System		14
Flector	Nonsteroidal anti-inflammatory drug	12
Folic acid		14
Gabapentin	Anti-epileptic agent	14
Gemtesa	beta3-Adrenergic agonist	5
Guaifenesin	Expectorant	25
Harvoni	Hepatitis C virus NS5A inhibitor	5
Ibrance	Kinase inhibitor	41
Ibuprofen	Nonsteroidal anti-inflammatory drug	6
Imbruvica	Kinase inhibitor	6
Imodium	Opioid agonist	34
Imodium A-D	Opioid agonist	42
Imodium Multi Symptom Relief		7
Imodium Multi-Symptom Relief		411
Intelence	Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	7
Isentress	Human immunodeficiency virus integrase strand transfer inhibitor	6
Isotretinoin	Retinoid	5
Janumet	Biguanide	10
Lansoprazole	Proton pump inhibitor	5
Latanoprost	Prostaglandin analog	5
Lenalidomide	Thalidomide analog	17
Lipitor	HMG-CoA reductase inhibitor	24
Lisinopril	Angiotensin converting enzyme inhibitor	7
Loratadine		6
Lyrica		5
Mavyret	Hepatitis C virus NS3/4A protease inhibitor	5
Metformin	Biguanide	9
Metformin hydrochloride	Biguanide	9
Methotrexate	Folate analog metabolic inhibitor	11
Minerals Vitamins		10
Mirtazapine		15
Molnupiravir		5
Morphine sulfate	Opioid agonist	7
Mucinex	Expectorant	35
Mucinex DM	Expectorant	14
Mucinex Dm Maximum Strength	Expectorant	75
Mucinex Maximum Strength	Expectorant	48
Myrbetriq	beta3-Adrenergic agonist	11
Naltrexone hydrochloride and bupropion hydrochloride	Aminoketone	5
Nexium 24HR	Proton pump inhibitor	15
Omeprazole	Proton pump inhibitor	36
Orserdu	Estrogen receptor antagonist	69
Oxbryta		46
Oxycodone hydrochloride	Opioid agonist	48
OxyContin	Opioid agonist	50
ParaGard T 380A	Copper-containing intrauterine device	14
Pataday		7
Pataday Once Daily Relief	Histamine-1 receptor antagonist	5
Paxlovid		144
Prempro	Estrogen	6
Prezista	Protease inhibitor	9
Qinlock	Kinase inhibitor	8
Ramipril	Angiotensin converting enzyme inhibitor	16
Rosuvastatin	HMG-CoA reductase inhibitor	5
Rosuvastatin calcium	HMG-CoA reductase inhibitor	5
Rytary	Aromatic amino acid	6
Stalevo		6
Strattera	Norepinephrine reuptake inhibitor	5
Synthroid	l-Thyroxine	19
Tamsulosin		12
Tamsulosin hydrochloride	alpha-Adrenergic blocker	5
Tirosint	l-Thyroxine	6
Topiramate		6
Trazodone		11
Triumeq	Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	6
Truvada	Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	7
Tylenol	Expectorant	9
Tylenol 8 HR Arthritis Pain		54
Tylenol 8HR		7
TYLENOL Extra Strength		29
Tylenol Regular Strength		33
Valacyclovir hydrochloride	Herpes simplex virus nucleoside analog DNA polymerase inhibitor	6
Vascepa		94
Venclexta	BCL-2 inhibitor	6
Vyndamax		13
Welchol		6
Xarelto	Factor Xa inhibitor	96
Xifaxan	Rifamycin antibacterial	36
Xtandi	Androgen receptor inhibitor	528
Zytiga	Cytochrome P450 17A1 inhibitor	106

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 5 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 Product size issue name, in order of name
Class	Reports with this term
alpha-Adrenergic blocker	5
Aminoketone	9
Androgen receptor inhibitor	609
Angiotensin converting enzyme inhibitor	25
Anti-epileptic agent	24
Aromatic amino acid	10
BCL-2 inhibitor	6
Benzodiazepine	17
beta-Adrenergic blocker	8
beta2-Adrenergic agonist	13
beta3-Adrenergic agonist	16
Biguanide	28
Calcium channel blocker	22
Central alpha-2 adrenergic agonist	9
Central nervous system stimulant	9
Copper-containing intrauterine device	14
Corticosteroid	5
Cytochrome P450 17A1 inhibitor	106
Cytochrome P450 3A inhibitor	9
Dihydropyridine calcium channel blocker	12
Estrogen	132
Estrogen receptor antagonist	69
Expectorant	212
Factor Xa inhibitor	104
Folate analog metabolic inhibitor	13
Hepatitis B virus nucleoside analog reverse transcriptase inhibitor	6
Hepatitis C virus NS3/4A protease inhibitor	7
Hepatitis C virus NS5A inhibitor	11
Herpes simplex virus nucleoside analog DNA polymerase inhibitor	8
Histamine-1 receptor antagonist	43
Histamine-2 receptor antagonist	8
HMG-CoA reductase inhibitor	54
Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor	7
Human immunodeficiency virus integrase strand transfer inhibitor	10
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	10
Kinase inhibitor	67
l-Thyroxine	35
Nonsteroidal anti-inflammatory drug	207
Norepinephrine reuptake inhibitor	7
Opioid agonist	193
Partial opioid agonist	51
Penicillin-class antibacterial	5
Poly(ADP-Ribose) polymerase inhibitor	5
Prostaglandin analog	9
Protease inhibitor	9
Proton pump inhibitor	71
Retinoid	12
Rifamycin antibacterial	36
Serotonin and norepinephrine reuptake inhibitor	6
Serotonin reuptake inhibitor	16
Thalidomide analog	19

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

Reports by month

Reports that record Product size issue, 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 Product size issue
Age	Reports	Share
Under 2	4	0.1%
2 to 11	46	0.9%
12 to 17	48	0.9%
18 to 44	171	3.3%
45 to 64	534	10.2%
65 to 74	609	11.6%
75 and over	1,018	19.4%
Age not given	2,817	53.7%

Sex of the patient in the reports that record Product size issue
Sex	Reports	Share
Female	2,645	50.4%
Male	1,893	36.1%
Unknown or not given	709	13.5%

Age and sex are as the report gives them. 90.5% 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. Product size issue: adverse event reports that record this term. https://reportedreactions.com/reaction/product-size-issue/ 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 Product size issue 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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