Affective disorder 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 2004 to June 2026, FDA received 7,724 adverse event reports that record the MedDRA preferred term Affective disorder. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 488 reports in the 12 months to June 2026 and 461 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 1,000 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, 488 (under 0.1%) record this term. Reports for patients aged 18 to 44 were 25.9% of the reports that record this term and 12.3% 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 126 drug pages with 25 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 Affective disorder name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	126
Abilify Maintena		35
Acetaminophen		28
Adderall	Central nervous system stimulant	26
Advair Hfa	Corticosteroid	48
Albuterol	beta2-Adrenergic agonist	30
Alprazolam	Benzodiazepine	35
Alvesco		59
Amitriptyline		28
Arava	Antirheumatic agent	40
Aripiprazole	Atypical antipsychotic	166
Atorvastatin		37
Avamys		29
Avonex	Interferon beta	25
Briviact		31
Bupropion hydrochloride	Aminoketone	25
Carbidopa levodopa	Aromatic amino acid	29
Champix		32
Chantix	Partial cholinergic nicotinic agonist	114
Chlorpromazine	Phenothiazine	79
Clonazepam	Benzodiazepine	48
Clozapine	Atypical antipsychotic	61
Clozaril	Atypical antipsychotic	92
Cosentyx	Interleukin-17A antagonist	67
Cymbalta		131
Depakote	Anti-epileptic agent	39
Dexamethasone	Corticosteroid	70
Diazepam	Benzodiazepine	28
Diclofenac	Nonsteroidal anti-inflammatory drug	25
Dilaudid	Opioid agonist	38
Docetaxel	Microtubule inhibitor	71
Duloxetine	Serotonin and norepinephrine reuptake inhibitor	36
Dupixent	Interleukin-4 receptor alpha antagonist	208
Enbrel	Tumor necrosis factor blocker	46
Escitalopram	Serotonin reuptake inhibitor	64
Euthyrox		40
Fentanyl	Opioid agonist	33
Finasteride	5-alpha reductase inhibitor	59
Flovent	Corticosteroid	42
Fluoxetine	Serotonin reuptake inhibitor	49
Fluticasone furoate	Corticosteroid	30
Gabapentin	Anti-epileptic agent	79
Gilenya	Sphingosine 1-phosphate receptor modulator	52
Glycopyrrolate	Anticholinergic	25
Golimumab	Tumor necrosis factor blocker	25
Haloperidol	Typical antipsychotic	72
Humira		139
Hydrocodone bitartrate and acetaminophen	Opioid agonist	53
Infliximab	Tumor necrosis factor blocker	30
Ipratropium bromide	Anticholinergic	68
Isotretinoin	Retinoid	26
Keppra		130
Lamictal	Anti-epileptic agent	52
Lamotrigine	Anti-epileptic agent	68
Latuda	Atypical antipsychotic	31
Letrozole	Aromatase inhibitor	31
Levetiracetam		145
Levofloxacin	Fluoroquinolone antibacterial	74
Lithium	Mood stabilizer	103
Lorazepam	Benzodiazepine	113
Lyrica		118
Methadone	Opioid agonist	49
Methotrexate	Folate analog metabolic inhibitor	94
Mirena	Progestin	194
Mirtazapine		69
Montelukast sodium	Leukotriene receptor antagonist	26
Morphine	Opioid agonist	29
Morphine sulfate	Opioid agonist	43
MS Contin	Opioid agonist	25
Nexplanon	Progestin	43
Novothyrox		236
Olanzapine	Atypical antipsychotic	151
Omeprazole	Proton pump inhibitor	40
Otezla	Phosphodiesterase 4 inhibitor	71
Oxycodone	Opioid agonist	34
Oxycodone and acetaminophen	Opioid agonist	45
Oxycodone hydrochloride	Opioid agonist	115
OxyContin	Opioid agonist	112
Paclitaxel	Microtubule inhibitor	59
Paroxetine	Serotonin reuptake inhibitor	37
Paxil	Serotonin reuptake inhibitor	34
Percocet	Opioid agonist	35
Pertuzumab	HER2/neu receptor antagonist	66
Prednisolone	Corticosteroid	57
Prednisone	Corticosteroid	200
Pregabalin		74
Propecia	5-alpha reductase inhibitor	33
Prozac	Serotonin reuptake inhibitor	40
Quetiapine	Atypical antipsychotic	76
Quetiapine fumarate	Atypical antipsychotic	32
Ramipril	Angiotensin converting enzyme inhibitor	34
Revlimid	Thalidomide analog	37
Ribavirin	Nucleoside analog antiviral	35
Risperdal	Atypical antipsychotic	84
Risperidone	Atypical antipsychotic	183
Rituximab	CD20-directed cytolytic antibody	29
Salbutamol sulfate		26
Seroquel	Atypical antipsychotic	111
Sertraline	Serotonin reuptake inhibitor	109
Sertraline hydrochloride	Serotonin reuptake inhibitor	26
Singulair	Leukotriene receptor antagonist	182
Strattera	Norepinephrine reuptake inhibitor	33
Sulfasalazine	Aminosalicylate	54
Symbicort	Corticosteroid	58
Tadalafil	Phosphodiesterase 5 inhibitor	27
Theophylline	Methylxanthine	42
Tiotropium bromide	Anticholinergic	31
Topiramate		57
Tramadol		63
Trastuzumab	HER2/neu receptor antagonist	72
Trikafta		43
Tysabri	Integrin receptor antagonist	41
Uniphyl		26
Valproic acid	Anti-epileptic agent	35
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	50
Venlafaxine hydrochloride	Serotonin and norepinephrine reuptake inhibitor	25
Vimpat		46
Vyvanse	Central nervous system stimulant	40
Xeljanz	Janus kinase inhibitor	33
Xgeva	RANK ligand inhibitor	26
Xyrem	Central nervous system depressant	94
Xywav	Central nervous system depressant	29
Zenatane	Retinoid	25
Zoloft	Serotonin reuptake inhibitor	37
Zuclopenthixol		60
Zyprexa	Atypical antipsychotic	29

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 59 pharmacologic classes with 25 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 Affective disorder name, in order of name
Class	Reports with this term
5-alpha reductase inhibitor	97
Aminoketone	68
Aminosalicylate	60
Angiotensin converting enzyme inhibitor	41
Anti-epileptic agent	345
Anti-IgE	26
Anticholinergic	132
Antirheumatic agent	48
Aromatase inhibitor	53
Aromatic amino acid	31
Atypical antipsychotic	1,234
Benzodiazepine	302
beta-Adrenergic blocker	50
beta2-Adrenergic agonist	60
Biguanide	30
Bisphosphonate	29
CD20-directed cytolytic antibody	74
Central nervous system depressant	125
Central nervous system stimulant	142
Corticosteroid	604
Estrogen	60
Fluoroquinolone antibacterial	95
Folate analog metabolic inhibitor	102
gamma-Aminobutyric acid A receptor positive modulator	39
GLP-1 receptor agonist	28
Gonadotropin releasing hormone receptor antagonist	29
HER2/neu receptor antagonist	138
HMG-CoA reductase inhibitor	47
Integrin receptor antagonist	51
Interferon beta	39
Interleukin-17A antagonist	69
Interleukin-4 receptor alpha antagonist	208
Janus kinase inhibitor	50
Kinase inhibitor	95
Leukotriene receptor antagonist	230
Loop diuretic	26
Methylxanthine	42
Microtubule inhibitor	130
Mood stabilizer	150
Nonsteroidal anti-inflammatory drug	106
Norepinephrine reuptake inhibitor	36
Nucleoside analog antiviral	35
Opioid agonist	677
Partial cholinergic nicotinic agonist	119
Partial opioid agonist	41
Phenothiazine	84
Phosphodiesterase 4 inhibitor	74
Phosphodiesterase 5 inhibitor	29
Progestin	254
Proton pump inhibitor	114
RANK ligand inhibitor	31
Retinoid	98
Serotonin and norepinephrine reuptake inhibitor	157
Serotonin reuptake inhibitor	506
Sphingosine 1-phosphate receptor modulator	64
Thalidomide analog	49
Tricyclic antidepressant	25
Tumor necrosis factor blocker	147
Typical antipsychotic	72

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

Reports by month

Reports that record Affective disorder, 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 Affective disorder
Age	Reports	Share
Under 2	36	0.5%
2 to 11	287	3.7%
12 to 17	356	4.6%
18 to 44	2,000	25.9%
45 to 64	1,669	21.6%
65 to 74	434	5.6%
75 and over	257	3.3%
Age not given	2,685	34.8%

Sex of the patient in the reports that record Affective disorder
Sex	Reports	Share
Female	4,286	55.5%
Male	2,751	35.6%
Unknown or not given	687	8.9%

Age and sex are as the report gives them. 58% 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. Affective disorder: adverse event reports that record this term. https://reportedreactions.com/reaction/affective-disorder/ 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 Affective disorder 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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