Prescription medicine
Imipramine First approved as Presamine
Imipramine (Presamine) is a prescription medicine with an FDA approval on record since 1959. FDA's NDC Directory lists it from 14 generic labelers, and pharmacies paid $0.0698 per imipramine HCl 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the imipramine FDA label on DailyMed (effective August 11, 2026, Leading Pharma, LLC); the NDA 11836 record on Drugs@FDA; every imipramine label on DailyMed.
Highlights of the record
FDA label of August 11, 2026; 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 imipramine 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. Imipramine hydrochloride is not approved for use in pediatric patients (see WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS, Information for Patients, and PRECAUTIONS: Pediatric Use ).
Used for
From the label: indications and usageDepression - For the relief of symptoms of depression.
Forms and strengths
- 10 mg
- 25 mg
- 50 mg
- 75 mg
- 100 mg
- 125 mg
- 150 mg
Film-coated tablet; tablet; capsule.
On the market
- Earliest approval on file
- April 16, 1959 Presamine, Sanofi Aventis Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 31 first June 27, 1974; 12 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 14 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.0698 per tablet Imipramine HCl 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2013 0 Class I among all firms' recalls; latest October 8, 2021; 1 more by firms not listed as its makers
- FAERS reports
- 723 through July 30, 2026
What is imipramine used for?
From the label: indications and usageDepression - For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. One to three weeks of treatment may be needed before optimal therapeutic effects are evident. Childhood Enuresis - May be useful as temporary adjunctive therapy in reducing enuresis in children aged 6 years and older, after possible organic causes have been excluded by appropriate tests. In patients having daytime symptoms of frequency and urgency, examination should include voiding cystourethrography and cystoscopy, as necessary. The effectiveness of treatment may decrease with continued drug administration.
Conditions named in the indications of imipramine's FDA labels, with every medicine labeled for each:
From other imipramine labelsDepression: INDICATIONS AND USAGE Depression - For the relief of symptoms of depression.
FDA pharmacologic class: Tricyclic Antidepressant.
Source: FDA drug label (Imipramine Hydrochloride), Leading Pharma, LLC, effective August 11, 2026 (SPL set 490263ce-b4d2-428a-87da-fcd07f85499a), via openFDA; the full label on DailyMed
Is there a generic for imipramine (Presamine)?
The FDA approved the first generic imipramine on June 27, 1974. 31 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 imipramine from 14 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1959 earliest approval on file
- 1974 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 imipramine (Presamine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.0698 per Imipramine HCl 10 mg tablet, down 12% from $0.0791 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. 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.
- Imipramine HCl 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Imipramine HCl 10 mg tablet | Generic | $0.0698 per tablet | $2.09 | -12% |
| Imipramine HCl 25 mg tablet | Generic | $0.0888 per tablet | $2.66 | +5% |
| Imipramine HCl 50 mg tablet | Generic | $0.156 per tablet | $4.67 | +15% |
| Imipramine pamoate 100 mg capsule | Generic | $3.65 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $109.51 | +2% |
| Imipramine pamoate 150 mg capsule | Generic | $2.69 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $80.73 | -18% |
| Imipramine pamoate 75 mg capsule | Generic | $3.24 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $97.16 | -25% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has imipramine been recalled?
The FDA's Enforcement Report lists 5 recalls naming imipramine since 2013: 0 Class I (the most serious), 2 Class II, 3 Class III; 0 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of imipramine 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 8, 2021 | Class II | Lupin Pharmaceuticals Inc. | Out of specification result observed in a dissolution test at the 9-month long term stability time point. |
| July 16, 2015 | Class III | Mutual Pharmaceutical Company, Inc. | Chemical Contamination; benzophenone leached from the product label varnish |
| July 2, 2013 | Class II | Aidapak Services, LLC not a listed maker | Labeling: Label Mixup: IMIPRAMINE HCL, Tablet, 25 mg may have potentially been mislabeled as the following drug: FENOFIBRATE, Tablet, 54 mg, NDC 00115551110 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the imipramine label say about other medicines?
The imipramine label names 11 other medicines in its interaction, contraindication or warning sections. The labels of 37 other medicines name imipramine. 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 |
|---|---|---|
| Cimetidine | 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). |
| Clonidine | warnings | … disorder because this drug has been shown to lower the seizure threshold; patients receiving guanethidine, clonidine, or similar agents, since imipramine hydrochloride tablets may block the pharmacologic effects of these drugs; patients receiving methylphenidate hydrochloride. |
| Epinephrine | drug interactions | Avoid the use of preparations, such as decongestants and local anesthetics, that contain any sympathomimetic amine (e.g., epinephrine, norepinephrine), since it has been reported that tricyclic antidepressants can potentiate the effects of catecholamines. |
| 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 | While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. |
| Methylphenidate | warnings | … since imipramine hydrochloride tablets may block the pharmacologic effects of these drugs; patients receiving methylphenidate hydrochloride. |
| Paroxetine | drug interactions | While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. |
| Phenytoin | drug interactions | … cimetidine, fluoxetine) and decrease by concomitant administration with hepatic enzyme inducers (e.g., barbiturates, phenytoin), and adjustment of the dosage of imipramine may therefore be necessary. |
| Propafenone | 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). |
| 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, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). |
| Sertraline | drug interactions | While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. |
Other labels that name imipramine
Source: FDA drug label (Imipramine Hydrochloride), Leading Pharma, LLC, effective August 11, 2026 (SPL set 490263ce-b4d2-428a-87da-fcd07f85499a), via openFDA; the full label on DailyMed
What do FAERS reports show for imipramine?
The FDA Adverse Event Reporting System holds 723 reports that list imipramine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 56 are coded as a death and 242 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 else is labeled for the same conditions as imipramine?
30 other medicines are given the same way (oral) and in the same FDA class as imipramine or labeled mainly for the same use (depression), the same class first. Depression lists all 37 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Amitriptyline | Depression | 36 labelers | $0.03 per tablet 10 mg tablet | No current entry |
| Doxepin | Depression | 48 labelers | $0.0779 per capsule 10 mg capsule | No current entry |
| Nortriptyline | Depression | 27 labelers | $0.113 per capsule 10 mg capsule | No current entry |
| Desipramine | Depression | 9 labelers | $0.276 per tablet 75 mg tablet | No current entry |
| Trimipramine | Depression | 3 labelers | n/a | No current entry |
| Amoxapine | Depression | 2 labelers | n/a | No current entry |
| Protriptyline | Depression | 2 labelers | $2.71 per tablet 10 mg tablet | No current entry |
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
Every medicine labeled for the same conditions as imipramine
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does imipramine compare with medicines for the same use?
5 side-by-side pages set imipramine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to imipramine
- 30 medicines for the same use
- Other tricyclic antidepressants
- the pharmacologic class, with prices and generics
- Imipramine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other