Anafranil (clomipramine hydrochloride) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Anafranil
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Clomipramine hydrochloride
Class: Tricyclic antidepressant
Also reported as: Anafranil Cap, Anafranil Capsules, Anafranil Sr

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.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 1,868 adverse event reports that name Anafranil. In these reports the drug is a suspect or interacting product.

In the same period, 1,881 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 56 reports in the 12 months to June 2026 and 77 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 56 (under 0.1%) name Anafranil. Reports from consumers or other non-health professionals were 20.8% of the reports that name Anafranil and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
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.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Anafranil is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

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

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
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.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 24 reports that name Anafranil.
In January to March 2026, FDA received 15.
In April to June 2025, FDA received 17.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 261 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,827 of the 1,868 reports (97.8%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 261 terms.

Reaction terms in the reports that name Anafranil, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,868 reports
Drug interactionan interaction between medicines	130	7%
Intentional overdosea deliberate overdose	109	5.8%
Falla fall	90	4.8%
Tremorshaking	89	4.8%
Somnolencedrowsiness	88	4.7%
Off label useused for a purpose or in a way not on the label	81	4.3%
Intentional self-injury	79	4.2%
Coma	74	4%
Suicide attempta suicide attempt	74	4%
Sopor	71	3.8%
Confusional stateconfusion	69	3.7%
Hypotensionlow blood pressure	68	3.6%
Constipation	64	3.4%
Drug abusemisuse of a medicine	64	3.4%
Product use in unapproved indicationused for a purpose not on the label	61	3.3%
Toxicity to various agentspoisoning or toxic effect of one or more substances	58	3.1%
Tachycardiafast heart rate	56	3%
Loss of consciousnesspassing out	55	2.9%
Overdosea dose above the recommended amount	55	2.9%
Anxiety	52	2.8%
Drug exposure during pregnancythe medicine was taken during pregnancy	51	2.7%
Hyponatraemialow blood sodium	51	2.7%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	49	2.6%
Electrocardiogram QT prolongeda QT prolongation on the ECG	47	2.5%
Neuroleptic malignant syndromea rare severe reaction with fever and rigidity	47	2.5%
Agitationrestlessness	41	2.2%
Astheniaweakness or lack of energy	41	2.2%
Malaisegeneral feeling of being unwell	41	2.2%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	41	2.2%
Drug ineffectivethe medicine did not work as expected	38	2%
Depressed level of consciousness	34	1.8%
Depressionlow mood	33	1.8%
Migraine	32	1.7%
Insomniadifficulty sleeping	31	1.7%
Mental disorder	30	1.6%
Visual impairmentreduced vision	29	1.6%
Hallucinationseeing or hearing things that are not there	28	1.5%
Nauseafeeling sick	28	1.5%
Poisoning deliberate	28	1.5%
Bronchial hyperreactivity	27	1.4%
Dizzinesslight-headedness or unsteadiness	27	1.4%
Dyspnoeashortness of breath	27	1.4%
Speech disordera speech problem	27	1.4%
Weight decreasedweight loss	27	1.4%
Drug intolerancethe medicine was not tolerated	26	1.4%
Drug withdrawal syndrome neonatal	26	1.4%
Breast disorder	25	1.3%
Dehydration	25	1.3%
Headachehead pain	25	1.3%
Intestinal obstructiona blocked bowel	25	1.3%

Download all 261 terms of Anafranil (CSV)

The counts add to more than 1,868 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. 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.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Clomipramine with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Clomipramine	Generic name	2,649
Clomipramine hydrochloride	Generic name	598
Anafranil (this page)	Brand name	1,868

Sum of the separately reported names: 5,115. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

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.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Anafranil, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	137	135	16	10	101	7	6	10	2
2005	86	83	16	6	51	6	2	14	3
2006	49	47	8	1	35	4	1	7	2
2007	45	44	5	11	30	0	0	11	1
2008	71	68	4	11	43	1	3	26	3
2009	53	52	5	12	38	0	0	18	1
2010	47	47	10	4	21	1	0	18	0
2011	48	45	2	3	24	0	1	28	3
2012	45	45	0	1	29	0	4	19	0
2013	88	81	12	17	48	1	1	30	7
2014	76	73	3	4	42	2	3	34	3
2015	63	57	10	7	36	0	0	26	6
2016	101	96	9	7	57	0	8	51	5
2017	89	84	9	13	55	2	4	48	5
2018	130	130	21	13	82	0	0	60	0
2019	162	160	13	15	101	0	0	72	2
2020	159	152	18	29	82	16	12	57	7
2021	52	50	3	2	19	8	4	30	2
2022	96	92	6	5	54	3	1	52	4
2023	84	84	4	8	52	1	0	41	0
2024	81	81	8	13	45	2	0	45	0
2025	59	59	1	9	24	4	3	49	0
2026	47	45	0	1	21	1	1	33	2

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

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.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Anafranil, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Anafranil, by the year in which FDA received them
Year	Reports
2004	134
2005	83
2006	47
2007	51
2008	67
2009	57
2010	52
2011	50
2012	59
2013	86
2014	73
2015	79
2016	104
2017	104
2018	133
2019	157
2020	145
2021	51
2022	97
2023	80
2024	75
2025	45
2026	39

Reports that name Anafranil, 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.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Anafranil
Age	Reports	Share
Under 2	73	3.9%
2 to 11	4	0.2%
12 to 17	28	1.5%
18 to 44	442	23.7%
45 to 64	520	27.8%
65 to 74	205	11%
75 and over	211	11.3%
Age not given	385	20.6%

Sex of the patient in the reports that name Anafranil
Sex	Reports	Share
Female	1,028	55%
Male	676	36.2%
Unknown or not given	164	8.8%

Type of reporter in the reports that name Anafranil
Reporter	Reports	Share
Physician	633	33.9%
Pharmacist	131	7%
Other health professional	518	27.7%
Lawyer	6	0.3%
Consumer or non-health professional	388	20.8%
Not given	192	10.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 6.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Anafranil record
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 reporter fills in the indication, and the field is often empty. Each share is of all 1,868 reports.

Pages near this one

Clomipramine same ingredient
Clomipramine hydrochloride same ingredient
Amoxapine same class
Amitriptyline hydrochloride same class
Desipramine same class
Amitriptyline hcl same class
Doxepin same class
Amvuttra next in the A to Z list
Anagrelide next in the A to Z list
Amsacrine next in the A to Z list
Anagrelide hydrochloride next in the A to Z list
Amrix next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for AnafranilThe labels (prescribing information) that have this name, at the National Library of Medicine.
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. Anafranil: adverse event reports that FDA received. https://reportedreactions.com/drug/anafranil/ 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.

A report is in the count when it names Anafranil as a suspect or interacting product. The 1,881 reports that name it only as a concomitant medicine are not in the count. 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

Do these reports show that Anafranil was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
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.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Anafranil?

No. It is a count of what people reported to FDA: 1,868 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (33.9%), other health professional (27.7%) and consumer or non-health professional (20.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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