Drugs › Tricyclic antidepressant
Brand name · Clomipramine hydrochloride
Anafranil: adverse event reports filed with FDA
1,868 reports list it as a suspect or interacting product, 2004–2026. Class: Tricyclic antidepressant. Also reported as Anafranil Cap, Anafranil Capsules, Anafranil Sr.
- 1,868
- reports as suspect product
- 0% of all reports · about 83 a year
- 56
- reports, 12 months to June 2026
- 77 in the 12 months before
- 96.9%
- marked serious by the reporter
- 88.7% across the class
- 9.8%
- record death among outcomes, as reported
- 183 reports · not verified by FDA
Between January 2004 and June 2026, 1,868 adverse event reports received by FDA list the brand name Anafranil (clomipramine hydrochloride) as a suspect or interacting product. Reports that mention it only as a concomitant medication (1,881) are left out of every figure here.
In the 12 months to June 2026, 56 reports listed it, down 27% from 77 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 83 reports a year and 0% of the 20,646,523 reports in the database, and 10.3% of the reports for the tricyclic antidepressant class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded drug interaction (7%), intentional overdose (5.8%) and fall (4.8%). A report can list several reactions, so shares add to more than 100%; 549 different terms appear across these reports. Drug interaction is recorded in 7% of these reports, about the same share as in the median tricyclic antidepressant drug (6.9%).
96.9% of the reports are marked serious by the reporter (88.7% across the class); 9.8% record death among the outcomes and 58.4% record hospitalisation, as reported. 33.9% of the reports came from physicians, and the largest patient age group is 45 to 64 (27.8%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Anafranil reports recording the termmedian drug in tricyclic antidepressant
- Drug interactionan interaction between medicines7%130
- Intentional overdosea deliberate overdose5.8%109
- Falla fall4.8%90
- Tremorshaking4.8%89
- Somnolencedrowsiness4.7%88
- Off label useused for a purpose or in a way not on the label4.3%81
- Intentional self-injury4.2%79
- Coma4%74
- Suicide attempta suicide attempt4%74
- Sopor3.8%71
- Confusional stateconfusion3.7%69
- Hypotensionlow blood pressure3.6%68
- Constipationconstipation3.4%64
- Drug abusemisuse of a medicine3.4%64
- Product use in unapproved indicationused for a purpose not on the label3.3%61
- Toxicity to various agentspoisoning or toxic effect of one or more substances3.1%58
- Tachycardiafast heart rate3%56
- Loss of consciousnesspassing out2.9%55
- Overdosea dose above the recommended amount2.9%55
- Anxietyanxiety2.8%52
- Drug exposure during pregnancythe medicine was taken during pregnancy2.7%51
- Hyponatraemialow blood sodium2.7%51
- Foetal exposure during pregnancythe unborn baby was exposed to the medicine2.6%49
- Electrocardiogram QT prolongeda QT prolongation on the ECG2.5%47
- Neuroleptic malignant syndromea rare severe reaction with fever and rigidity2.5%47
- Agitationrestlessness2.2%41
- Astheniaweakness or lack of energy2.2%41
- Malaisegeneral feeling of being unwell2.2%41
- Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor2.2%41
- Drug ineffectivethe medicine did not work as expected2%38
Top 30 of 549 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 11 drugs in the tricyclic antidepressant class; it describes the reports, not the patients. 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."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 18,174 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 6.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Depression | 449 | 24% |
| Major depression | 43 | 2.3% |
| Obsessive-compulsive disorder | 42 | 2.2% |
| Bipolar disorder | 41 | 2.2% |
| Migraine | 30 | 1.6% |
| Mixed anxiety and depressive disorder | 16 | 0.9% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,868 reports.
In context
| Measure | Anafranil | Tricyclic antidepressant | All reports |
|---|---|---|---|
| Reports as suspect product | 1,868 | 18,174 | 20,646,523 |
| Share of that pool | — | 10.3% | 0% |
| Reports, latest 12 months | 56 | — | 1,332,454 |
| Marked serious | 96.9% | 88.7% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 98 | 295 | 91 |
| Hospitalisation recorded, per 1,000 reports | 584 | 351 | 213 |
| Consumer-filed share | 20.8% | 19% | 45.8% |
| Top term, share of reports | Drug interaction 7% | median 6.9% | 0.8% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."
Other drugs in the tricyclic antidepressant class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Amitriptyline hydrochloride | generic | 4,504 | 341 | 90% |
| Doxepin | generic | 3,134 | 193 | 88.7% |
| Amitriptyline hcl | generic | 2,553 | 0 | 91.4% |
| Nortriptyline hydrochloride | generic | 1,702 | 225 | 84.4% |
| Doxepin hcl | generic | 1,107 | 0 | 81% |
| Doxepin hydrochloride | generic | 860 | 43 | 78% |
| Pamelor | brand | 678 | 23 | 73.7% |
| Clomipramine hydrochloride | generic | 598 | 73 | 92.1% |
| Trimipramine | generic | 589 | 41 | 98.6% |
| Nortriptyline hcl | generic | 581 | 0 | 86.4% |
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." A brand and its generic are separate rows because reporters name them separately.
Questions about Anafranil reports
How many adverse event reports has FDA received for Anafranil?
1,868 reports list Anafranil as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 56 of them arrived in the latest 12 months. Another 1,881 list it only as a concomitant medication.
What reactions are recorded in Anafranil reports?
drug interaction (7%), intentional overdose (5.8%), fall (4.8%), tremor (4.8%) and somnolence (4.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Anafranil was responsible.
How serious are the reports?
96.9% are marked serious by the reporter. Among the outcomes recorded, 9.8% of reports include death and 58.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (33.9%), other health professional (27.7%) and consumer or non-health professional (20.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Anafranil rising?
56 reports in the 12 months to June 2026, down 27% from 77 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Anafranil was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Anafranil?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Anafranil as a suspect or interacting product; reports listing it only as a concomitant medication (1,881) are excluded. 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.