Abnormal weight gain 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 2008 to June 2026, FDA received 12,314 adverse event reports that record the MedDRA preferred term Abnormal weight gain. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 220 reports in the 12 months to June 2026 and 104 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 1,307 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, 220 (under 0.1%) record this term. Reports for male patients were 82.4% of the reports that record this term and 34.6% 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 125 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 Abnormal weight gain name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	85
Abilify Maintena		12
Adalimumab	Tumor necrosis factor blocker	8
Adderall	Central nervous system stimulant	21
Adempas	Soluble guanylate cyclase stimulator	40
Ambrisentan	Endothelin receptor antagonist	5
Amitriptyline		6
Amlodipine	Calcium channel blocker	34
Anastrozole	Aromatase inhibitor	8
Apixaban	Factor Xa inhibitor	10
Aripiprazole	Atypical antipsychotic	69
Atorvastatin		69
Bisoprolol	beta-Adrenergic blocker	8
Candesartan	Angiotensin 2 receptor blocker	7
Cetirizine	Histamine-1 receptor antagonist	10
Cetirizine hydrochloride	Histamine-1 receptor antagonist	6
Citalopram	Serotonin reuptake inhibitor	69
Citalopram Hydrobromide - Bp		6
Clarithromycin	Macrolide antimicrobial	7
Clonidine	Central alpha-2 adrenergic agonist	10
Clopidogrel	P2Y12 platelet inhibitor	5
Clozapine	Atypical antipsychotic	16
Concerta	Central nervous system stimulant	32
Corticotropin		57
Depakote	Anti-epileptic agent	74
Dianeal Low Calcium Peritoneal Dialysis Solution with Dextrose		15
Doxazosin	alpha-Adrenergic blocker	5
Dupixent	Interleukin-4 receptor alpha antagonist	18
Entresto	Angiotensin 2 receptor blocker	8
Esomeprazole	Proton pump inhibitor	6
Finasteride	5-alpha reductase inhibitor	26
Fluoxetine	Serotonin reuptake inhibitor	14
Fosamax	Bisphosphonate	7
Furosemide	Loop diuretic	6
Gabapentin	Anti-epileptic agent	48
GAMMAGARD Liquid	Human immunoglobulin G	6
Geodon	Atypical antipsychotic	14
Haldol		15
Haldol Decanoate		5
Haloperidol	Typical antipsychotic	20
Humira		25
Ibuprofen	Nonsteroidal anti-inflammatory drug	6
Insulin glargine	Insulin analog	5
Invega	Atypical antipsychotic	1,650
Invega Sustenna	Atypical antipsychotic	315
Invega Trinza	Atypical antipsychotic	5
Lamictal	Anti-epileptic agent	6
Lamotrigine	Anti-epileptic agent	20
Letrozole	Aromatase inhibitor	19
Levetiracetam		5
Levothyroxine		8
Lexapro	Serotonin reuptake inhibitor	6
Lipitor	HMG-CoA reductase inhibitor	5
Lisinopril	Angiotensin converting enzyme inhibitor	9
Lithium	Mood stabilizer	13
Lorazepam	Benzodiazepine	10
Lormetazepam		7
Losartan	Angiotensin 2 receptor blocker	13
Lurasidone		6
Lustral		6
Lyrica		7
Metformin	Biguanide	13
Mirena	Progestin	146
Mirtazapine		126
Montelukast	Leukotriene receptor antagonist	35
Montelukast sodium	Leukotriene receptor antagonist	13
Nexplanon	Progestin	20
Novothyrox		58
Nutropin Aq		5
Nuvaring	Estrogen	8
Olanzapine	Atypical antipsychotic	136
Omeprazole	Proton pump inhibitor	32
Opsumit	Endothelin receptor antagonist	19
Orenitram	Prostacycline vasodilator	7
Paliperidone	Atypical antipsychotic	9
Paliperidone palmitate	Atypical antipsychotic	11
Pantoprazole	Proton pump inhibitor	11
Paxil	Serotonin reuptake inhibitor	6
Pioglitazone	Peroxisome proliferator receptor alpha agonist	10
Pradaxa	Direct thrombin inhibitor	6
Prednisolone	Corticosteroid	16
Prednisone	Corticosteroid	18
Pregabalin		34
Propranolol	beta-Adrenergic blocker	5
Prozac	Serotonin reuptake inhibitor	19
Quetiapine	Atypical antipsychotic	103
Quetiapine fumarate	Atypical antipsychotic	38
Ramipril	Angiotensin converting enzyme inhibitor	11
Remeron		5
Remicade	Tumor necrosis factor blocker	15
Rinvoq	Janus kinase inhibitor	6
Risperdal	Atypical antipsychotic	9,218
Risperdal Consta		458
Risperdal M-Tab	Atypical antipsychotic	344
Risperidone	Atypical antipsychotic	2,847
Ritalin	Central nervous system stimulant	5
Rituximab	CD20-directed cytolytic antibody	5
Rosuvastatin	HMG-CoA reductase inhibitor	11
Seroquel	Atypical antipsychotic	92
Sertraline	Serotonin reuptake inhibitor	122
Sertraline hcl	Serotonin reuptake inhibitor	10
Sertraline hydrochloride	Serotonin reuptake inhibitor	9
Simvastatin	HMG-CoA reductase inhibitor	33
Slynd		5
Spironolactone	Aldosterone antagonist	9
Synthroid	l-Thyroxine	9
Tamsulosin		14
Ticagrelor	P2Y12 platelet inhibitor	11
Tiotropium bromide	Anticholinergic	18
Topamax		6
Topiramate		15
Trazodone		8
Uptravi	Prostacyclin receptor agonist	5
Valproate sodium	Anti-epileptic agent	5
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	51
Venlafaxine hcl	Serotonin and norepinephrine reuptake inhibitor	5
Venlafaxine hydrochloride	Serotonin and norepinephrine reuptake inhibitor	11
Vyvanse	Central nervous system stimulant	6
Xarelto	Factor Xa inhibitor	26
Yasmin		6
Zofran		5
Zoledronic acid	Bisphosphonate	5
Zoloft	Serotonin reuptake inhibitor	10
Zopiclone		14
Zyprexa	Atypical antipsychotic	64

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 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 Abnormal weight gain name, in order of name
Class	Reports with this term
5-alpha reductase inhibitor	30
Aldosterone antagonist	9
Allylamine antifungal	5
alpha-Adrenergic blocker	7
Angiotensin 2 receptor blocker	32
Angiotensin converting enzyme inhibitor	25
Anti-epileptic agent	159
Anticholinergic	18
Aromatase inhibitor	29
Atypical antipsychotic	15,016
Benzodiazepine	20
beta-Adrenergic blocker	28
Biguanide	13
Bisphosphonate	15
Calcium channel blocker	34
CD20-directed cytolytic antibody	8
Central alpha-2 adrenergic agonist	18
Central nervous system stimulant	71
Corticosteroid	48
Cytochrome P450 3A inhibitor	11
Dipeptidyl peptidase 4 inhibitor	6
Direct thrombin inhibitor	6
Endothelin receptor antagonist	28
Estrogen	14
Factor Xa inhibitor	40
GLP-1 receptor agonist	6
Histamine-1 receptor antagonist	27
HMG-CoA reductase inhibitor	54
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	7
Human immunoglobulin G	8
Insulin analog	16
Interleukin-23 antagonist	5
Interleukin-4 receptor alpha antagonist	18
Interleukin-6 receptor antagonist	6
Janus kinase inhibitor	11
l-Thyroxine	9
Leukotriene receptor antagonist	48
Loop diuretic	6
Macrolide antimicrobial	7
Mood stabilizer	21
Nonsteroidal anti-inflammatory drug	10
P2Y12 platelet inhibitor	16
Peroxisome proliferator receptor alpha agonist	15
Progestin	168
Prostacyclin receptor agonist	5
Prostacycline vasodilator	13
Proton pump inhibitor	55
Serotonin and norepinephrine reuptake inhibitor	75
Serotonin reuptake inhibitor	281
Soluble guanylate cyclase stimulator	40
Tumor necrosis factor blocker	30
Typical antipsychotic	20

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

Reports by month

Reports that record Abnormal weight gain, 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 Abnormal weight gain
Age	Reports	Share
Under 2	9	0.1%
2 to 11	619	5%
12 to 17	562	4.6%
18 to 44	1,557	12.6%
45 to 64	882	7.2%
65 to 74	238	1.9%
75 and over	109	0.9%
Age not given	8,338	67.7%

Sex of the patient in the reports that record Abnormal weight gain
Sex	Reports	Share
Female	1,893	15.4%
Male	10,145	82.4%
Unknown or not given	276	2.2%

Age and sex are as the report gives them. 83.5% 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. Abnormal weight gain: adverse event reports that record this term. https://reportedreactions.com/reaction/abnormal-weight-gain/ 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 Abnormal weight gain 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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