Bipolar disorder adverse event reports that record this term

Kind of term: MedDRA preferred term
Plain meaning: bipolar disorder

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 10,775 adverse event reports that record the MedDRA preferred term Bipolar disorder. In plain words, the term means: bipolar disorder. The person who codes a report selects the term that agrees best with the description of the reporter.

FDA received 403 reports in the 12 months to June 2026 and 391 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 1,098 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, 403 (under 0.1%) record this term. Reports for patients aged 18 to 44 were 25.1% 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.

Plain meaning

Bipolar disorder. The words are from the fixed dictionary of this site. They add nothing to a report.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Drugs in these reports

The table has the 129 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 Bipolar disorder name as a suspect product, in order of name
Drug	Class	Reports with this term
Abilify	Atypical antipsychotic	233
Abilify Maintena		55
Accutane	Retinoid	130
Acetaminophen Oxycodone Hydrochloride		35
Adderall	Central nervous system stimulant	26
Aripiprazole	Atypical antipsychotic	105
Austedo		31
Avonex	Interferon beta	179
Buprenorphine Transdermal Patch		33
Bupropion hydrochloride	Aminoketone	52
Butrans	Partial opioid agonist	25
Carbamazepine	Mood stabilizer	55
Champix		50
Chantix	Partial cholinergic nicotinic agonist	489
Citalopram	Serotonin reuptake inhibitor	34
Clarithromycin	Macrolide antimicrobial	25
Clonazepam	Benzodiazepine	63
Clozapine	Atypical antipsychotic	120
Clozaril	Atypical antipsychotic	66
Codeine		33
Concerta	Central nervous system stimulant	31
Cosentyx	Interleukin-17A antagonist	47
Crestor	HMG-CoA reductase inhibitor	36
Cymbalta		178
Depakote	Anti-epileptic agent	137
Desvenlafaxine succinate	Serotonin and norepinephrine reuptake inhibitor	42
Dexamethasone	Corticosteroid	25
Dilaudid	Opioid agonist	94
Dupixent	Interleukin-4 receptor alpha antagonist	47
Duragesic-100		32
Effexor	Serotonin and norepinephrine reuptake inhibitor	63
Enbrel	Tumor necrosis factor blocker	118
Escitalopram	Serotonin reuptake inhibitor	38
Fentanyl	Opioid agonist	37
Fluoxetine	Serotonin reuptake inhibitor	42
Fosamax	Bisphosphonate	56
Gabapentin	Anti-epileptic agent	32
Geodon	Atypical antipsychotic	111
Gilenya	Sphingosine 1-phosphate receptor modulator	54
Heroin		39
Humalog	Insulin analog	34
Humira		257
Hydrocodone bitartrate	Opioid agonist	32
Hydrocodone bitartrate and acetaminophen	Opioid agonist	138
Hydromorphone Tablets		35
Ingrezza	Vesicular monoamine transporter 2 inhibitor	55
Invega Sustenna	Atypical antipsychotic	58
Lamictal	Anti-epileptic agent	176
Lamotrigine	Anti-epileptic agent	130
Latuda	Atypical antipsychotic	248
Levetiracetam		66
Lexapro	Serotonin reuptake inhibitor	56
Lisinopril	Angiotensin converting enzyme inhibitor	27
Lithium	Mood stabilizer	126
Lithium carbonate	Mood stabilizer	62
Lyrica		125
Magnesium		27
Methotrexate	Folate analog metabolic inhibitor	44
Mirena	Progestin	39
Mirtazapine		30
Montelukast	Leukotriene receptor antagonist	26
Morphine sulfate	Opioid agonist	99
Mounjaro	GLP-1 receptor agonist	25
MS Contin	Opioid agonist	57
Neurontin		102
Nexium	Proton pump inhibitor	172
Nuvaring	Estrogen	50
Ocrevus	CD20-directed cytolytic antibody	40
Olanzapine	Atypical antipsychotic	156
Omeprazole	Proton pump inhibitor	45
Otezla	Phosphodiesterase 4 inhibitor	39
Oxycodone	Opioid agonist	29
Oxycodone and acetaminophen	Opioid agonist	110
Oxycodone hydrochloride	Opioid agonist	262
OxyContin	Opioid agonist	228
Oxyir		29
Ozempic	GLP-1 receptor agonist	44
Pantoprazole	Proton pump inhibitor	36
Paxil	Serotonin reuptake inhibitor	88
Peg-Intron		25
Pegasys	Interferon alpha	28
Percocet	Opioid agonist	77
Prednisone	Corticosteroid	61
Prevacid	Proton pump inhibitor	27
Prilosec	Proton pump inhibitor	47
Pristiq	Serotonin and norepinephrine reuptake inhibitor	32
Propecia	5-alpha reductase inhibitor	27
Prozac	Serotonin reuptake inhibitor	68
Quetiapine	Atypical antipsychotic	82
Quetiapine fumarate	Atypical antipsychotic	59
Rebif	Interferon beta	108
Remicade	Tumor necrosis factor blocker	57
Ribavirin	Nucleoside analog antiviral	28
Risperdal	Atypical antipsychotic	43
Risperidone	Atypical antipsychotic	81
Ritalin	Central nervous system stimulant	67
Rivotril		25
Seroquel	Atypical antipsychotic	957
Sertraline	Serotonin reuptake inhibitor	47
Singulair	Leukotriene receptor antagonist	91
Skyrizi	Interleukin-23 antagonist	27
Spravato		37
Strattera	Norepinephrine reuptake inhibitor	50
Suboxone	Opioid antagonist	57
Symbicort	Corticosteroid	44
Tecfidera		109
Tegretol	Mood stabilizer	32
Topamax		43
Topiramate		38
Tramadol		83
Trazodone		25
Trileptal	Anti-epileptic agent	51
Tysabri	Integrin receptor antagonist	184
Valproate sodium	Anti-epileptic agent	39
Valproic acid	Anti-epileptic agent	36
Venlafaxine	Serotonin and norepinephrine reuptake inhibitor	44
Venlafaxine hydrochloride	Serotonin and norepinephrine reuptake inhibitor	124
Vicodin		41
Vioxx		53
Vivitrol		30
Vraylar	Atypical antipsychotic	31
Vyvanse	Central nervous system stimulant	49
Xanax	Benzodiazepine	82
Xeljanz	Janus kinase inhibitor	41
Xyrem	Central nervous system depressant	367
Xywav	Central nervous system depressant	80
Yaz		31
Zoloft	Serotonin reuptake inhibitor	133
Zyprexa	Atypical antipsychotic	172

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 53 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 Bipolar disorder name, in order of name
Class	Reports with this term
5-alpha reductase inhibitor	34
Alkylating drug	34
Aminoketone	101
Angiotensin 2 receptor blocker	41
Angiotensin converting enzyme inhibitor	27
Anti-epileptic agent	649
Anti-IgE	25
Atypical antipsychotic	2,665
Benzodiazepine	279
Bisphosphonate	80
Calcineurin inhibitor immunosuppressant	30
Calcium channel blocker	27
CD20-directed cytolytic antibody	67
Central nervous system depressant	462
Central nervous system stimulant	217
Corticosteroid	189
Estrogen	54
Folate analog metabolic inhibitor	52
GLP-1 receptor agonist	123
HMG-CoA reductase inhibitor	60
Human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor	36
Insulin analog	67
Integrin receptor antagonist	211
Interferon alpha	28
Interferon beta	300
Interleukin-17A antagonist	47
Interleukin-23 antagonist	29
Interleukin-4 receptor alpha antagonist	47
Janus kinase inhibitor	55
Kinase inhibitor	40
Leukotriene receptor antagonist	129
Macrolide antimicrobial	27
Mood stabilizer	275
Nonergot dopamine agonist	32
Nonsteroidal anti-inflammatory drug	69
Norepinephrine reuptake inhibitor	56
Nucleoside analog antiviral	28
Opioid agonist	1,324
Opioid antagonist	59
Partial cholinergic nicotinic agonist	499
Partial opioid agonist	59
Penicillin-class antibacterial	31
Phosphodiesterase 4 inhibitor	39
Phosphodiesterase 5 inhibitor	26
Progestin	68
Proton pump inhibitor	449
Provitamin D2 compound	26
Retinoid	147
Serotonin and norepinephrine reuptake inhibitor	332
Serotonin reuptake inhibitor	602
Sphingosine 1-phosphate receptor modulator	57
Tumor necrosis factor blocker	240
Vesicular monoamine transporter 2 inhibitor	65

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

Reports by month

Reports that record Bipolar 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 Bipolar disorder
Age	Reports	Share
Under 2	5	under 0.1%
2 to 11	112	1%
12 to 17	250	2.3%
18 to 44	2,702	25.1%
45 to 64	2,340	21.7%
65 to 74	458	4.3%
75 and over	132	1.2%
Age not given	4,776	44.3%

Sex of the patient in the reports that record Bipolar disorder
Sex	Reports	Share
Female	6,548	60.8%
Male	3,570	33.1%
Unknown or not given	657	6.1%

Age and sex are as the report gives them. 73.2% 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. Bipolar disorder: adverse event reports that record this term. https://reportedreactions.com/reaction/bipolar-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 Bipolar disorder mean in an adverse event report?

In plain words: bipolar disorder. 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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