Imipramine
Imipramine is a tricyclic antidepressant used to treat depression, and imipramine hydrochloride tablets are also used as add-on treatment for bedwetting (childhood enuresis) in children 6 and older.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 23 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Imipramine is a classic tricyclic antidepressant, on the market since about 1959 and available generically, thought to boost norepinephrine, a brain chemical; it is now usually a later choice for depression, and the tablets also serve as a short-term add-on for bedwetting in children 6 and older. It is harder to tolerate than newer antidepressants; dry mouth, constipation, drowsiness and dizziness on standing are the usual complaints. Its boxed warning covers suicidal thoughts and behavior in children, teens and young adults up to 24, so watch closely for worsening mood or unusual behavior after starting. Benefit takes one to three weeks, and it should be tapered, never stopped suddenly.
Clinical pearls
- For bedwetting, the tablet is usually given about an hour before bedtime, and its effect may fade with continued use.
- Tell your dentist before numbing injections, since anesthetics with epinephrine and cold-medicine decongestants act more strongly with imipramine.
- Lock it away from children; an imipramine overdose can be fatal, and children are especially sensitive.
- Fluoxetine, sertraline and paroxetine can raise imipramine levels, and fluoxetine lingers at least five weeks after stopping.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Antidepressants like imipramine can increase suicidal thoughts and behavior in children, teens, and young adults (up to age 24). This was seen in short-term studies. Adults over 24 did not show this increase, and adults 65 and older had a lower risk.
Depression itself raises suicide risk. Anyone starting imipramine should be watched closely for worsening depression, suicidal thoughts, or unusual changes in behavior. Families and caregivers should stay in close contact with the prescriber. Imipramine hydrochloride is not approved for use in children for depression.
Patient information guide A plain-language walkthrough of Imipramine, written from its FDA label.
What Imipramine is used for
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Imipramine is used for these conditions:
- Depression: relief of symptoms (imipramine hydrochloride tablets and imipramine pamoate capsules).
- Childhood bedwetting (enuresis): temporary add-on therapy in children 6 and older, after other causes are ruled out (imipramine hydrochloride tablets only).
How Imipramine works
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Imipramine is a tricyclic antidepressant. Its exact way of working isn't known. It is thought to increase norepinephrine activity by blocking its re-uptake at nerve endings.
Its effect on bedwetting is thought to be separate from its antidepressant action.
Imipramine dosage
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Imipramine is taken by mouth. Your prescriber starts you low and adjusts based on response and tolerance.
- Depression: often once daily at bedtime, or in divided doses for some people.
- Bedwetting (Imipramine Hydrochloride tablets): about an hour before bedtime. Some children may also get an earlier dose.
- Full antidepressant benefit may take one to three weeks.
- Don't stop suddenly after long-term use. Your prescriber will taper the dose.
Follow your prescriber and label directions.
Dosing details from the FDA-approved label
From the Imipramine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Outpatients (depression, imipramine pamoate capsules, initial adult dosage)
- Therapy initiated at 75 mg/day
- Dosage may be increased to 150 mg/day, the level at which optimum response is usually obtained
- If necessary may be increased to 200 mg/day
- Dosage higher than 75 mg/day may be given once a day
- Daily dosage may be given at bedtime, or in divided doses in some patients
- Maximum: 200 mg/day
- Antidepressant effect may not be evident for one to three weeks in some patients
- Hospitalized patients (depression, imipramine pamoate capsules, initial adult dosage)
- Therapy initiated at 100 to 150 mg/day and may be increased to 200 mg/day
- If no response after two weeks, increase to 250 to 300 mg/day
- Dosage higher than 150 mg/day may be given once a day, at bedtime if desired
- Antidepressant effect may not be evident for one to three weeks in some patients
- Adult maintenance dosage (imipramine pamoate capsules)
- Usual maintenance dosage is 75 to 150 mg/day, at the lowest dose that will maintain remission
- Total daily dosage can be given once a day, preferably at bedtime, or divided
- After remission, dosage should gradually be decreased; in relapse due to premature withdrawal, reinstitute the effective dosage
- Adolescent and geriatric patients (imipramine pamoate capsules label)
- Initiate with imipramine hydrochloride tablets (Tofranil) at a total daily dosage of 25 to 50 mg
- May be increased according to response and tolerance
- Capsules may be used when total daily dosage is established at 75 mg or higher
- Maximum: Generally unnecessary to exceed 100 mg/day
- Can usually be maintained at lower dosage
- Depression, hospitalized patients (imipramine hydrochloride tablets)
- Initially 100 mg/day in divided doses gradually increased to 200 mg/day as required
- If no response after two weeks, increase to 250 to 300 mg/day
- Lower dosages recommended for elderly patients and adolescents
- Depression, outpatients (imipramine hydrochloride tablets)
- Initially 75 mg/day increased to 150 mg/day
- Maintenance, 50 to 150 mg/day
- Maximum: Dosages over 200 mg/day are not recommended
- Lower dosages recommended for outpatients than for hospitalized patients
- Depression, adolescent and geriatric patients (imipramine hydrochloride tablets)
- Initially 30 to 40 mg/day
- Maximum: Generally not necessary to exceed 100 mg/day
- Lower dosages recommended for elderly patients and adolescents
- Childhood enuresis (children aged 6 and older)
- Initially 25 mg/day, given one hour before bedtime
- If no satisfactory response within one week, increase to 50 mg nightly in children under 12 years
- Children over 12 may receive up to 75 mg nightly
- In early night bedwetters, 25 mg in midafternoon, repeated at bedtime
- Maximum: 75 mg daily; a dose of 2.5 mg/kg/day should not be exceeded
- Safety and effectiveness not established in children less than 6 years; taper gradually rather than abruptly discontinue
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION The following recommended dosages for imipramine pamoate capsules should be modified as necessary by the clinical response and any evidence of intolerance. Initial Adult Dosage Outpatients Therapy should be initiated at 75 mg/day. Dosage may be increased to 150 mg/day which is the dose level at which optimum response is usually obtained. If necessary, dosage may be increased to 200 mg/day. Dosage higher than 75 mg/day may also be administered on a once-a-day basis after the optimum dosage and tolerance have been determined. The daily dosage may be given at bedtime. In some patients it may be necessary to employ a divided-dose schedule. As with all tricyclics, the antidepressant effect of imipramine may not be evident for one to three weeks in some patients. Hospitalized Patients Therapy should be initiated at 100 to 150 mg/day and may be increased to 200 mg/day. If there is no response after two weeks, dosage should be increased to 250 to 300 mg/day. Dosage higher than 150 mg/day may also be administered on a once-a-day basis after the optimum dosage and tolerance have been determined. The daily dosage may be given at bedtime. In some patients it may be necessary to employ a divided-dose schedule. As with all tricyclics, the antidepressant effect of imipramine may not be evident for one to three weeks in some patients. Adult Maintenance Dosage Following remission, maintenance medication may be required for a longer period of time at the lowest dose that will maintain remission after which the dosage should gradually be decreased. The usual maintenance dosage is 75 to 150 mg/day. The total daily dosage can be administered on a once-a-day basis, preferably at bedtime. In some patients it may be necessary to employ a divided-dose schedule. In cases of relapse due to premature withdrawal of the drug, the effective dosage of imipramine should be reinstituted. Adolescent and Geriatric Patients Therapy in these age groups should be initiated with Tofranil™, brand of imipramine hydrochloride tablets, at a total daily dosage of 25 to 50 mg, since imipramine pamoate capsules are not available in these strengths. Dosage may be increased according to response and tolerance, but it is generally unnecessary to exceed 100 mg/day in these patients. Imipramine pamoate capsules may be used when total daily dosage is established at 75 mg or higher.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Imipramine side effects
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Common side effects include:
Common side effects
- Dry mouth
- Blurred vision
- Constipation
- Drowsiness, dizziness and fatigue
- Nausea
- Weight gain or loss
- Sweating
- Lightheadedness when standing up
- Nausea and stomach upset
When to get medical help
- Call your doctor right away if you or a loved one has new or worsening depression, suicidal thoughts, or unusual changes in behavior.
- Get help for fast or irregular heartbeat, chest pain, or signs of a stroke.
- Get help for seizures, hallucinations, or severe confusion, especially in older adults.
- Seek care for severe eye pain or vision changes, which can signal angle-closure glaucoma.
- Report fever, sore throat, or unusual bruising or bleeding, which can signal blood problems.
- Report yellowing of the skin or eyes, which can signal liver problems.
- Seek help for swelling of the face or tongue, or a severe rash.
- Report being unable to urinate or severe constipation.
In children treated for bedwetting, the most common effects are nervousness, sleep problems, tiredness, and mild stomach upset. Get help right away for heart rhythm problems, seizures, severe confusion, eye pain, signs of a blood disorder, or suicidal thoughts.
Imipramine warnings and precautions
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- Suicidality: antidepressants raise the risk of suicidal thoughts and behavior in children, teens, and young adults. Watch closely, especially early on.
- Heart effects: imipramine can cause arrhythmias, heart block, blood pressure changes, and has been linked to heart attack and stroke.
- Other risks: seizures, confusion, angle-closure glaucoma, liver changes, and low sodium.
- Stopping suddenly: can cause nausea, headache, and malaise.
Imipramine interactions
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Imipramine can clash with many drugs.
- MAOIs, linezolid, IV methylene blue: serotonin syndrome risk.
- SSRIs and other CYP2D6 inhibitors: can raise imipramine levels.
- Barbiturates and phenytoin: can lower levels.
- Anticholinergic drugs: stronger dry mouth, constipation, and bowel blockage.
- Decongestants and local anesthetics with epinephrine-like ingredients: avoid.
- Blood pressure medicines: use caution.
- Alcohol and CNS depressants: increased sedation.
Interactions listed in the FDA-approved label
From the Imipramine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Drugs that inhibit cytochrome P450 2D6 (quinidine, cimetidine, other antidepressants, phenothiazines, propafenone, flecainide): They can raise TCA plasma concentrations, and a patient stable on a TCA dose may become abruptly toxic. May require lower doses of the TCA or the other drug; an increased TCA dose may be needed when the other drug is withdrawn; monitor TCA plasma levels.
- SSRIs (fluoxetine, sertraline, paroxetine): All inhibit P450 2D6, to varying extents, which may cause clinical problems with TCAs. Use caution when coadministering or switching classes; allow sufficient time (at least 5 weeks may be necessary) before starting a TCA after withdrawing fluoxetine.
- Hepatic enzyme inhibitors (cimetidine, fluoxetine): Plasma concentration of imipramine may increase. Dosage adjustment of imipramine may be necessary.
- Hepatic enzyme inducers (barbiturates, phenytoin): Plasma concentration of imipramine may decrease. Dosage adjustment of imipramine may be necessary.
- Anticholinergic drugs (including antiparkinsonism agents): Atropine-like effects may become more pronounced (e.g., paralytic ileus). Close supervision and careful dosage adjustment required.
- Sympathomimetic amines (e.g., epinephrine, norepinephrine; decongestants and local anesthetics containing them): Tricyclic antidepressants can potentiate the effects of catecholamines. Avoid use of such preparations.
- Agents that lower blood pressure: Label does not state a specific effect. Caution should be exercised.
- CNS depressant drugs: Imipramine may potentiate the effects of CNS depressant drugs.
- Alcohol: Imipramine may enhance the CNS depressant effects of alcohol. Patients should be warned.
Read the label’s full interactions text
Drug Interactions Drugs Metabolized by P450 2D6 : The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the Caucasian population (about 7% to 10% of Caucasians are so-called "poor metabolizers"); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African, and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8-fold increase in plasma AUC of the TCA). In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. 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). 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. The extent to which SSRI-TCA interaction may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Imipramine
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- Do not use it during the acute recovery period after a heart attack.
- Do not use it if you are allergic to tricyclic antidepressants.
- Do not combine it with MAOIs, or use within 14 days of stopping one.
- Not approved for depression in children. For bedwetting, it is for ages 6 and older.
- Older adults and teens typically need lower doses.
Imipramine overdose
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Overdose of imipramine can be fatal, and any amount in a young child is serious. Signs include dangerous heart rhythms, very low blood pressure, seizures, and coma. Get emergency help right away and contact poison control.
What Imipramine does in the body
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Imipramine is thought to boost norepinephrine activity by blocking its re-uptake at nerve endings. It does not work mainly by stimulating the central nervous system.
How to store Imipramine
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Store at 25°C (77°F); excursions permitted to 15°-30°C (59°- 86°F) . Dispense in tight container (USP) with a child-resistant closure.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Imipramine
254 supplements and herbal products have documented interactions with Imipramine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 11
- Moderate · 190
- Minor · 53
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Imipramine has been associated with lower levels of 3 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
- Higher significance · 1
- Moderate · 1
- Unrated · 1
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Imipramine: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Imipramine — the kind of thing our pharmacy team would talk through with you at the counter.
What is imipramine used for?
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How soon will it work?
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Can I stop taking it if I feel better?
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What side effects should I expect?
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What should I avoid while taking it?
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Is it safe for kids and teens?
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Is Imipramine available over the counter?
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When was Imipramine first available?
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Who makes Imipramine?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Imipramine on HelloPharmacist
Imipramine forms and strengths (how it comes)
Imipramine is available in 2 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Tablet
How this form is used
- Imipramine Hydrochloride tablets are used to relieve symptoms of depression.
- Imipramine Hydrochloride tablets are used as temporary add-on therapy for bedwetting in children 6 and older.
- Imipramine Hydrochloride tablets are taken by mouth, starting low and increasing gradually.
- For bedwetting, Imipramine Hydrochloride tablets are generally given about one hour before bedtime.
- Imipramine Hydrochloride tablets should be tapered gradually rather than stopped suddenly in children treated for bedwetting.
Capsule
How this form is used
- Imipramine Pamoate capsules are used to relieve symptoms of depression.
- Imipramine Pamoate capsules are taken by mouth, and the dose is adjusted to your response and tolerance.
- Imipramine Pamoate capsules can often be taken once daily, preferably at bedtime, though some people need divided doses.
- Imipramine Pamoate capsules are not available in the lowest strengths, so teens and older adults may start on tablets and switch to capsules once their dose is established.
Imipramine on the U.S. market: products, makers and brands
How Imipramine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
14 companies list 40 Imipramine product records with the FDA, mostly as tablet, capsule; the earliest marketing or approval year on record is 1959. Brand names on the directory include Tofranil, Tofranil PM, Imipramine Pamoate; the rest are generics.
FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
Also listed with the FDA, not a patient dose form: Powder (5) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Imipramine is used (Medicaid data)
A general measure of how commonly Imipramine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Imipramine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Imipramine prescribed? Of the 1,601 medications we measure, Imipramine ranks #604 by Medicaid prescriptions — more than 62% of them.
Utilization by Imipramine product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
imipramine hydrochloride 25 MG Oral Tablet Most dispensed
Summed across the 6 of 51 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835564
imipramine hydrochloride 50 MG Oral Tablet
Summed across the 4 of 39 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835568
imipramine hydrochloride 10 MG Oral Tablet
Summed across the 3 of 35 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835593
imipramine pamoate 100 MG Oral Capsule
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835591
imipramine pamoate 75 MG Oral Capsule
Summed across the 2 of 5 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835572
imipramine pamoate 150 MG Oral Capsule
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 835577
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Imipramine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 17 of 138 listed Imipramine NDCs with Medicaid activity.
Compare Imipramine products
A representative set of FDA-listed product records for Imipramine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Capsule | ||||
| 75 mg | Oral | Hikma Pharmaceuticals USA Inc | ANDA | View NDC → |
| 100 mg | Oral | Hikma Pharmaceuticals USA Inc | ANDA | View NDC → |
| 125 mg | Oral | Hikma Pharmaceuticals USA Inc | ANDA | View NDC → |
| 150 mg | Oral | Hikma Pharmaceuticals USA Inc | ANDA | View NDC → |
| 75 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 100 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 125 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 150 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View NDC → |
| 75 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 💊Tablet | ||||
| 25 mg | Oral | A-S Medication Solutions | ANDA | View NDC → |
| 10 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 25 mg | Oral | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | View NDC → |
| 10 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 25 mg | Oral | Bryant Ranch Prepack | ANDA | View NDC → |
| 25 mg | Oral | Coupler LLC | ANDA | View NDC → |
| 25 mg | Oral | Key Therapeutics | ANDA | View NDC → |
| 10 mg | Oral | Leading Pharma, LLC | ANDA | View NDC → |
| 25 mg | Oral | Leading Pharma, LLC | ANDA | View NDC → |
| 50 mg | Oral | Leading Pharma, LLC | ANDA | View NDC → |
| 10 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View label ↗ |
| 25 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View label ↗ |
| 50 mg | Oral | Lupin Pharmaceuticals, Inc. | ANDA | View label ↗ |
| 50 mg | Oral | NuCare Pharmaceuticals, Inc. | ANDA | View NDC → |
| 10 mg | Oral | Oxford Pharmaceuticals, LLC | ANDA | View NDC → |
| 25 mg | Oral | Oxford Pharmaceuticals, LLC | ANDA | View NDC → |
| 50 mg | Oral | Oxford Pharmaceuticals, LLC | ANDA | View NDC → |
| 10 mg | Oral | PD-Rx Pharmaceuticals, Inc. | ANDA | View NDC → |
| 25 mg | Oral | PD-Rx Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 50 mg | Oral | PD-Rx Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 10 mg | Oral | Proficient Rx LP × 2 listings | ANDA | View NDC → |
| 25 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 50 mg | Oral | Proficient Rx LP | ANDA | View NDC → |
| 25 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 50 mg | Oral | Remedyrepack Inc. | ANDA | View NDC → |
| 10 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 25 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
| 50 mg | Oral | Strides Pharma Science Limited | ANDA | View NDC → |
Showing 40 of 40 products — FDA National Drug Code Directory. See every product, package size and price: browse all 40 Imipramine NDCs →
Imipramine side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Imipramine — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Imipramine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Imipramine FDA approval history
How Imipramine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Imipramine recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list one Imipramine recall since July 2021. It is no longer listed as ongoing. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 4… Lots: lot H002205, exp. date 08/2023 FDA record D-0027-2022 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 5691 3 dose forms · 8 strengths
-
Dose form (SCDF) Oral Capsule RxCUI 370680In current FDA listingsClinical drug / strength (SCD) pamoate 100 MGRxCUI 835591pamoate 125 MGRxCUI 835589pamoate 150 MGRxCUI 835577pamoate 75 MGRxCUI 835572 -
Dose form (SCDF) Oral Solution RxCUI 756959No current FDA listingClinical drug / strength (SCD) hydrochloride 5 MG/MLRxCUI 835586 -
Dose form (SCDF) Oral Tablet RxCUI 370679In current FDA listingsClinical drug / strength (SCD) hydrochloride 10 MGRxCUI 835593hydrochloride 25 MGRxCUI 835564hydrochloride 50 MGRxCUI 835568
Look up RxCUI 5691 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Imipramine supply and shortage status
Whether Imipramine is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
💵 What Imipramine costs pharmacies (NADAC benchmark)
The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.
| Form | Strength | Pharmacy acquisition benchmark | |
|---|---|---|---|
| Tablet · Oral | 25 mg | $0.089 per tablet | NDC details & price history |
| Tablet · Oral | 50 mg | $0.156 per tablet | NDC details & price history |
| Tablet · Oral | 10 mg | $0.070 per tablet | NDC details & price history |
| Capsule · Oral | 75 mg | $3.24 per capsule | NDC details & price history |
| Capsule · Oral | 150 mg | $2.69 per capsule | NDC details & price history |
| Capsule · Oral | 100 mg | $3.65 per capsule | NDC details & price history |
Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.
Imipramine brand names
Imipramine is sold under 3 brand names in the FDA directory — Tofranil, Tofranil PM, Imipramine Pamoate. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Imipramine: manufacturers and labelers
14 companies list Imipramine products with the FDA. By number of product records, the largest are Lupin Pharmaceuticals, Inc., PD-Rx Pharmaceuticals, Inc., Hikma Pharmaceuticals USA Inc. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Imipramine drug class (RxNorm)
Imipramine belongs to the Tricyclic Antidepressant class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Imipramine page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Proficient Rx LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →