Prescription medication · Tricyclic Antidepressant (TCA)
imipramine
Also sold as Tofranil. This medicine can help relieve the symptoms of depression.
Data updated 2026-05-15
- 537
- FDA reportsRarely reported
- 20
- InteractionsSeveral interactions
- $0.07
- Generic price (NADAC)
What the data shows
imipramine (Tofranil) is a prescription Tricyclic Antidepressant (TCA), among the least-reported drugs the FDA tracks (537 FDA reports), with 20 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
imipramine (Tofranil) is a prescription Tricyclic Antidepressant (TCA). This medicine can help relieve the symptoms of depression.
Imipramine (Tofranil) is a medicine used to treat depression and bedwetting in children. It helps improve mood and reduce bedwetting episodes.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.07/unit
Generic Available
Yes (8 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
NADAC price trail: IMIPRAMINE HCL 10 MG TABLET
Same CMS presentation as the headline generic unit price above (2 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: +1.3% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| April 17, 2024 | $0.0707/EA | - | 2 |
| December 18, 2024 | $0.0716/EA | +1.3% | 6 |
What it does
This medicine can help relieve the symptoms of depression.
Common side effects
Dry mouth, Blurred vision, Constipation
Key warnings
Antidepressants may increase the risk of suicidal thoughts and behavior in children, teenagers, and young adults.
The sections below are summarized in plain English from imipramine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Imipramine is a tricyclic antidepressant. It works by increasing the levels of certain natural chemicals in the brain that help regulate mood. For bedwetting, it's thought to affect bladder control.
Side Effects (from patient reports)
Based on 537 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for imipramine, by number of reports
- Dizziness
Dizziness
35 reports
- Fatigue
Fatigue
30 reports
- Hypertension
Hypertension
29 reports
- Anxiety
Anxiety
28 reports
- Depression
Depression
28 reports
- Dyspnoea
Dyspnoea
28 reports
- Hallucination, Auditory
Hallucination, Auditory
28 reports
- Psychotic Disorder
Psychotic Disorder
28 reports
- Headache
Headache
27 reports
- Drug Interaction
Drug Interaction
25 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for imipramine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where imipramine sits
imipramine has more FDA adverse-event reports than 3% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is imipramine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 537 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
537
Reports Mentioning Death
30
5.6% of reports — not proof of cause
Hospitalization Reports
198
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 2 | DIZZINESS | 35 |
| 4 | FATIGUE | 30 |
| 5 | HYPERTENSION | 29 |
| 6 | ANXIETY | 28 |
| 7 | DEPRESSION | 28 |
| 8 | DYSPNOEA | 28 |
| 9 | HALLUCINATION, AUDITORY | 28 |
| 10 | PSYCHOTIC DISORDER | 28 |
| 11 | HEADACHE | 27 |
| 12 | DRUG INTERACTION | 25 |
| 13 | NAUSEA | 25 |
| 14 | PARANOIA | 25 |
| 15 | ARTHRALGIA | 24 |
| 16 | PNEUMONIA | 21 |
| 17 | ASTHENIA | 20 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Antidepressants may increase the risk of suicidal thoughts and behavior in children, teenagers, and young adults. Your doctor will monitor you closely for worsening depression, suicidal thoughts, or unusual changes in behavior. Families and caregivers should also watch for these changes.
Known 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.
Mechanism: Imipramine can make the effects of epinephrine much stronger, which could cause a dangerous physical reaction.
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.
Mechanism: Imipramine can make the effects of norepinephrine much stronger, which could lead to serious side effects.
7 DRUG INTERACTIONS CNS depressants, including alcohol: Possible adverse additive CNS- depressant effects ( 5.1 , 7.1 ) Opioids: Concomitant use may increase risk of respiratory depression ( 5.7 , 7.1 ) Imipramine: Decreased alertness observed ( 7.1 ) Chlorpromazine: Impaired alertness and psychomotor performance observed ( 7.1 ) CYP3A4 inducers (rifampin or St. Limit dosage and duration of concomitant use of Zolpidem Tartrate Tablets and opioids [ see Dosage and Administration ( 2.3 ), Warnings and Precautions ( 5.7 )] Imipramine, Chlorpromazine Imipramine in combination with Zolpidem...
Mechanism: Both drugs slow down the central nervous system, which can lead to a combined effect that makes you feel much less alert.
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.
Mechanism: Sertraline interferes with how your liver processes imipramine, which can lead to higher levels of imipramine in your blood.
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.
Mechanism: Paroxetine blocks the enzyme that breaks down imipramine, which can cause imipramine to build up to high levels in your body.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
How long does it take for this medicine to work?
Can I stop taking this medicine suddenly?
What should I avoid while taking this medicine?
Will this medicine cure my depression?
Can this medicine cause weight gain?
Can this medicine affect my heart?
Is it safe to take other medicines with this?
What if the bedwetting comes back after stopping the medicine?
Can this medicine cause seizures?
What should I do if I have side effects?
What are the common side effects of imipramine?
Does imipramine interact with other medications?
What drug class is imipramine?
What pregnancy or breastfeeding source fields are listed for imipramine?
Related Medications in Tricyclic Antidepressant (TCA)
Other drugs grouped near imipramine - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with imipramine →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with imipramine →
amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
Compare with imipramine →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with imipramine →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with imipramine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for imipramine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 537.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 5.59%.
- insulin glargine Δ 0.02 pts · 236,147 reports · Long-Acting Insulin 5.60%death share
- aripiprazole Δ 0.03 pts · 118,365 reports · Atypical Antipsychotic 5.56%death share
- sulindac Δ 0.04 pts · 2,380 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 5.55%death share
- ustekinumab Δ 0.06 pts · 98,899 reports · Anti-IL-12/23 Monoclonal Antibody 5.53%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
Save on imipramine
Compare prices and find discounts at pharmacies near you. Free coupons can save up to 80% on prescriptions.
Disclosure: This link may earn us a commission at no extra cost to you. See our terms.
What the FDA Data Shows for imipramine
The FDA label for imipramine (sold under brand names such as Tofranil) classifies it as a prescription-only medication in the Tricyclic Antidepressant (TCA) class. This medicine can help relieve the symptoms of depression. Official labeling lists 8 commonly reported side effects, including Dry mouth, Blurred vision, Constipation.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 537 voluntary reports. The database also lists 20 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.07.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: September 18, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages