Prescription medicine
Clomipramine Brand names: Anafranil
Clomipramine (Anafranil) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 16 generic labelers, and pharmacies paid $0.189 per clomipramine 25 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the clomipramine FDA label on DailyMed (effective November 26, 2024); the NDA 19906 record on Drugs@FDA; every clomipramine label on DailyMed.
Highlights of the record
FDA label of November 26, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Suicidality and Antidepressant Drugs Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of clomipramine hydrochloride or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Clomipramine hydrochloride is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) ( see WARNINGS, Clinical Worsening and Suicide Risk; PRECAUTIONS, Information for Patients; and PRECAUTIONS, Pediatric Use ).
Used for
From the label: indications and usageClomipramine Hydrochloride Capsules USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD).
Forms and strengths
- 25 mg
- 50 mg
- 75 mg
Capsule.
On the market
- Earliest approval on file
- December 29, 1989 Anafranil, Specgx Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 21 first March 29, 1996; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 16 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.189 per capsule Clomipramine 25 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 7 since 2013 0 Class I among all firms' recalls; latest October 22, 2025; 1 more by firms not listed as its makers
- FAERS reports
- 4,505 through July 30, 2026
What is clomipramine used for?
From the label: indications and usageClomipramine Hydrochloride Capsules USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. […]
FDA pharmacologic class: Tricyclic Antidepressant.
Source: FDA drug label (CLOMIPRAMINE HYDROCHLORIDE), SpecGx LLC, effective November 26, 2024 (SPL set d7cee3fa-d05c-4702-8f75-f446627bdb49), via openFDA; the full label on DailyMed
Is there a generic for clomipramine (Anafranil)?
The FDA approved the first generic clomipramine on March 29, 1996. 21 generic applications are approved; 12 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists clomipramine from 16 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1989 earliest approval on file
- 1996 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for clomipramine (Anafranil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.189 per Clomipramine 25 mg capsule, down 29% from $0.267 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Clomipramine 25 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Clomipramine 25 mg capsule | Generic | $0.189 per capsule | $5.66 | -29% |
| Clomipramine 50 mg capsule | Generic | $0.258 per capsule | $7.74 | -4% |
| Clomipramine 75 mg capsule | Generic | $0.250 per capsule | $7.50 | -31% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has clomipramine been recalled?
The FDA's Enforcement Report lists 8 recalls naming clomipramine since 2013: 0 Class I (the most serious), 7 Class II, 1 Class III; 3 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of clomipramine and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| October 22, 2025 | Class II | Zydus Pharmaceuticals (USA) Inc | cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA … |
| June 27, 2025 | Class II | Lupin Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during … |
| April 10, 2025 | Class II | Lupin Pharmaceuticals Inc. | Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during … |
| August 23, 2022 | Class III | Leading Pharma, LLC | Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules |
| November 6, 2020 | Class II | Jubilant Cadista Pharmaceuticals, Inc. | Failed Tablet/Capsule Specification |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup; clomiPRAMINE HCl Capsule, 50 mg may be potentially mislabeled as guanFACINE HCl, Tablet, 1 mg, NDC 00378116001, Pedigree: AD46265_25 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the clomipramine label say about other medicines?
The clomipramine label names 21 other medicines in its interaction, contraindication or warning sections. The labels of 13 other medicines name clomipramine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Buspirone | warnings | … serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous … |
| Cimetidine | drug interactions | … reported to be increased by the concomitant administration of methylphenidate or hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decreased by the concomitant administration of hepatic enzyme inducers (e.g., barbiturates, phenytoin), and such an effect may be anticipated with CMI as well. |
| Clonidine | drug interactions | Several tricyclic antidepressants have been reported to block the pharmacologic effects of guanethidine, clonidine, or similar agents, and such an effect may be anticipated with CMI because of its structural similarity to other tricyclic antidepressants. |
| Digoxin | drug interactions | Because clomipramine hydrochloride capsules are highly bound to serum protein, the administration of clomipramine hydrochloride capsules to patients taking other drugs that are highly bound to protein (e.g., warfarin, digoxin) may cause an increase in plasma concentrations of these drugs, potentially resulting in … |
| Fentanyl | warnings | … particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also … |
| Flecainide | drug interactions | The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). |
| Fluoxetine | drug interactions | … increased by the concomitant administration of methylphenidate or hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decreased by the concomitant administration of hepatic enzyme inducers (e.g., barbiturates, phenytoin), and such an effect may be anticipated with CMI as well. |
| Fluvoxamine | drug interactions | While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, paroxetine, and fluvoxamine, inhibit P450 2D6, they may vary in the extent of inhibition. |
| Haloperidol | drug interactions | The plasma concentration of CMI has been reported to be increased by the concomitant administration of haloperidol; plasma levels of several closely related tricyclic antidepressants have been reported to be increased by the concomitant administration of methylphenidate or hepatic enzyme inhibitors (e.g., cimetidine … |
| Linezolid | contraindications | Starting clomipramine hydrochloride capsules in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome ( see WARNINGS and DOSAGE AND ADMINISTRATION ). |
| Lithium | warnings | … with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as … |
| Methylene blue | contraindications | Starting clomipramine hydrochloride capsules in a patient who is being treated with linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome ( see WARNINGS and DOSAGE AND ADMINISTRATION ). |
| Methylphenidate | drug interactions | The plasma concentration of CMI has been reported to be increased by the concomitant administration of haloperidol; plasma levels of several closely related tricyclic antidepressants have been reported to be increased by the concomitant administration of methylphenidate or hepatic enzyme inhibitors (e.g., cimetidine … |
| Paroxetine | drug interactions | While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, paroxetine, and fluvoxamine, inhibit P450 2D6, they may vary in the extent of inhibition. |
Every other medicine the clomipramine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Phenobarbital | drug interactions | Administration of CMI has been reported to increase the plasma levels of phenobarbital, if given concomitantly ( see CLINICAL PHARMACOLOGY, Interactions ). |
| Phenytoin | drug interactions | … concomitant administration of hepatic enzyme inducers (e.g., barbiturates, phenytoin), and such an effect may be anticipated with CMI as well. |
| Propafenone | drug interactions | … other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). |
| Quinidine | drug interactions | The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants … |
| Sertraline | drug interactions | While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, paroxetine, and fluvoxamine, inhibit P450 2D6, they may vary in the extent of inhibition. |
| Tramadol | warnings | … (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both … |
| Warfarin | drug interactions | … patients taking other drugs that are highly bound to protein (e.g., warfarin, digoxin) may cause an increase in plasma concentrations of these drugs, potentially resulting in adverse effects. |
Other labels that name clomipramine
Source: FDA drug label (CLOMIPRAMINE HYDROCHLORIDE), SpecGx LLC, effective November 26, 2024 (SPL set d7cee3fa-d05c-4702-8f75-f446627bdb49), via openFDA; the full label on DailyMed
What do FAERS reports show for clomipramine?
The FDA Adverse Event Reporting System holds 4,505 reports that list clomipramine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 394 are coded as a death and 2,429 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Alternatives to clomipramine
- medicines labeled for the same conditions
- Other tricyclic antidepressants
- the pharmacologic class, with prices and generics
- Clomipramine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other