Pharmacologic class (EPC) · 11 drug pages

Tricyclic antidepressant: adverse event reports filed with FDA

18,174 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.

18,174
reports across the class: 0.1% of all reports; 995
reports, 12 months to June 2026: 1,223 in the 12 months before; 88.7%
marked serious by the reporter: 57.4% across all reports; 11
drugs with a page: brand and generic names counted separately

Tricyclic antidepressant is a pharmacologic class (an FDA Established Pharmacologic Class) with 11 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 18,174 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

995 reports arrived in the 12 months to June 2026, down 19% from 1,223 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 88.7% of the class's reports are marked serious, 29.5% record death among the outcomes and 35.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are completed suicide (12.8%), toxicity to various agents (12.2%) and drug ineffective (8%). 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
Amitriptyline hydrochloride	generic	4,504	341	90%	Toxicity to various agents
Doxepin	generic	3,134	193	88.7%	Toxicity to various agents
Amitriptyline hcl	generic	2,553	0	91.4%	Completed suicide
AnafranilClomipramine hydrochloride	brand	1,868	56	96.9%	Drug interaction
Nortriptyline hydrochloride	generic	1,702	225	84.4%	Off label use
Doxepin hcl	generic	1,107	0	81%	Completed suicide
Doxepin hydrochloride	generic	860	43	78%	Completed suicide
PamelorNortriptyline hydrochloride	brand	678	23	73.7%	Completed suicide
Clomipramine hydrochloride	generic	598	73	92.1%	Coma
Trimipramine	generic	589	41	98.6%	Toxicity to various agents
Nortriptyline hcl	generic	581	0	86.4%	Completed suicide

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

Completed suicidedeath by suicide12.8%2,319
Toxicity to various agentspoisoning or toxic effect of one or more substances12.2%2,214
Drug ineffectivethe medicine did not work as expected8%1,453
Painpain, site not specified7.1%1,295
Off label useused for a purpose or in a way not on the label7%1,274
Drug interactionan interaction between medicines6.7%1,218
Falla fall5.9%1,073
Constipationconstipation5.5%1,007
Overdosea dose above the recommended amount5.2%954
Somnolencedrowsiness5.2%939
Hypotensionlow blood pressure5%911
Coma4.5%815
Headachehead pain4.4%802
Depressed level of consciousness4.2%762
Drug abusemisuse of a medicine4.2%762
Fatiguetiredness4.1%742
Hyperhidrosisexcessive sweating4.1%741
Balance disorderproblems with balance3.9%713
Sedationdrowsiness from a medicine3.9%706
Nauseafeeling sick3.8%690
Dizzinesslight-headedness or unsteadiness3.8%689
Product use in unapproved indicationused for a purpose not on the label3.7%667
Cardiac arrestthe heart stopped3.4%619
Cardio-respiratory arrestthe heart and breathing stopped3.4%609
Hypertensionhigh blood pressure3.3%592

Solid bar: share of all class reports. Hollow bar: the median share across the 11 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death29.5%5,366

Life-threatening7.6%1,389

Hospitalisation (initial or prolonged)35.1%6,386

Disability2.5%458

Congenital anomaly1.2%216

Other serious47%8,544

Not serious11.3%2,059

Patient age

Under 21.1%204

2 to 110.7%131

12 to 171.3%239

18 to 4424.9%4,531

45 to 6429.6%5,373

65 to 748.9%1,611

75 and over8.6%1,569

Age not given24.8%4,516

Who reported

Physician32.3%5,877

Pharmacist10%1,823

Other health professional32.6%5,920

Lawyer0.4%76

Consumer or non-health professional19%3,446

Not given5.7%1,032

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 Tricyclic antidepressant reports

Which drugs are in the Tricyclic antidepressant class on this site?

Amitriptyline hydrochloride, Doxepin, Amitriptyline hcl, Anafranil, Nortriptyline hydrochloride and Doxepin hcl and 5 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

18,174 reports through June 2026, 995 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?

completed suicide (12.8%), toxicity to various agents (12.2%), drug ineffective (8%), pain (7.1%) and off label use (7%).

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.