Pharmacologic class (EPC) · 4 drug pages

Mood stabilizer: adverse event reports filed with FDA

57,019 reports list a drug in this class as a suspect or interacting product, 2004–2026.

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.

57,019
reports across the class: 0.3% of all reports; 2,979
reports, 12 months to June 2026: 2,912 in the 12 months before; 91.4%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Mood stabilizer is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 57,019 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

2,979 reports arrived in the 12 months to June 2026, close to the 2,912 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 91.4% of the class's reports are marked serious, 10% record death among the outcomes and 43.3% record hospitalisation, as reported.

Across the class the reactions recorded most often are toxicity to various agents (9.9%), drug ineffective (9.1%) and drug interaction (8.4%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Carbamazepine	generic	22,081	1,516	93.6%	Drug ineffective
TegretolCarbamazepine	brand	16,844	477	89.7%	Seizure
Lithium	generic	10,787	720	90.8%	Toxicity to various agents
Lithium carbonate	generic	7,307	266	89.8%	Toxicity to various agents

Ordered by report count for navigation only. 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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Toxicity to various agentspoisoning or toxic effect of one or more substances9.9%5,630
Drug ineffectivethe medicine did not work as expected9.1%5,189
Drug interactionan interaction between medicines8.4%4,763
Seizurea fit or convulsion4.8%2,709
Somnolencedrowsiness4%2,283
Falla fall3.9%2,205
Off label useused for a purpose or in a way not on the label3.9%2,203
Pyrexiafever3.9%2,200
Tremorshaking3.8%2,174
Vomitingbeing sick3.8%2,171
Dizzinesslight-headedness or unsteadiness3.7%2,129
Nauseafeeling sick3.6%2,059
Completed suicidedeath by suicide3.2%1,810
Rashskin rash3.2%1,810
Fatiguetiredness3.1%1,788
Overdosea dose above the recommended amount3.1%1,784
Confusional stateconfusion3.1%1,746
Convulsion3%1,733
Condition aggravatedthe condition being treated got worse3%1,692
Hypotensionlow blood pressure2.7%1,529
Suicide attempta suicide attempt2.6%1,477
Painpain, site not specified2.6%1,455
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement2.5%1,428
Balance disorderproblems with balance2.4%1,381
Weight increasedweight gain2.4%1,350

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death10%5,701

Life-threatening7.1%4,023

Hospitalisation (initial or prolonged)43.3%24,693

Disability2.3%1,305

Congenital anomaly2.6%1,501

Other serious58.6%33,437

Not serious8.6%4,888

Patient age

Under 21.1%654

2 to 112.9%1,674

12 to 173.5%1,990

18 to 4423.8%13,546

45 to 6422.3%12,732

65 to 748.7%4,963

75 and over6.5%3,716

Age not given31.1%17,744

Who reported

Physician27.1%15,426

Pharmacist8.1%4,591

Other health professional38.7%22,056

Lawyer0.2%114

Consumer or non-health professional20.2%11,500

Not given5.8%3,332

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Mood stabilizer reports

Which drugs are in the Mood stabilizer class on this site?

Carbamazepine, Tegretol, Lithium and Lithium carbonate. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

57,019 reports through June 2026, 2,979 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

toxicity to various agents (9.9%), drug ineffective (9.1%), drug interaction (8.4%), seizure (4.8%) and somnolence (4%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.