Prescription medicine
Amitriptyline First approved as Elavil
Amitriptyline (Elavil) is a prescription medicine with an FDA approval on record since 1961. FDA's NDC Directory lists it from 34 generic labelers, and pharmacies paid $0.03 per amitriptyline HCl 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the amitriptyline FDA label on DailyMed (effective September 8, 2026, Sun Pharmaceutical Industries, Inc.); the NDA 12703 record on Drugs@FDA; every amitriptyline label on DailyMed.
Highlights of the record
FDA label of September 8, 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 amitriptyline 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. Amitriptyline 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 usageFor the relief of symptoms of depression.
Forms and strengths
- 10 mg
- 25 mg
- 50 mg
- 75 mg
- 100 mg
- 150 mg
Film-coated tablet; tablet; coated tablet.
On the market
- Earliest approval on file
- April 7, 1961 Elavil, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 77 first November 16, 1976; 19 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 34 of which 34 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.03 per tablet Amitriptyline HCl 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2017 0 Class I among all firms' recalls; latest June 16, 2017
- FAERS reports
- 17,441 through July 30, 2026
What is amitriptyline used for?
From the label: indications and usageFor the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
Conditions named in the indications of amitriptyline's FDA labels, with every medicine labeled for each:
From other amitriptyline labelsDepression: INDICATIONS AND USAGE For the relief of symptoms of depression.
FDA pharmacologic class: Tricyclic Antidepressant.
Source: FDA drug label (Amitriptyline Hydrochloride), Sun Pharmaceutical Industries, Inc., effective September 8, 2026 (SPL set 4e520c63-1cf6-40f6-a51c-3f9b0e181342), via openFDA; the full label on DailyMed
Is there a generic for amitriptyline (Elavil)?
The FDA approved the first generic amitriptyline on November 16, 1976. 77 generic applications are approved; 19 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 amitriptyline from 34 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.
- 1961 earliest approval on file
- 1976 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 amitriptyline (Elavil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.03 per Amitriptyline HCl 10 mg tablet, down 19% from $0.037 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.
- Amitriptyline HCl 10 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amitriptyline HCl 10 mg tablet | Generic | $0.03 per tablet | $0.899 | -19% |
| Amitriptyline HCl 100 mg tablet | Generic | $0.143 per tablet | $4.28 | -16% |
| Amitriptyline HCl 150 mg tablet | Generic | $0.290 per tablet | $8.70 | +11% |
| Amitriptyline HCl 25 mg tablet | Generic | $0.0522 per tablet | $1.57 | -2% |
| Amitriptyline HCl 50 mg tablet | Generic | $0.0963 per tablet | $2.89 | +5% |
| Amitriptyline HCl 75 mg tablet | Generic | $0.122 per tablet | $3.67 | -9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has amitriptyline been recalled?
The FDA's Enforcement Report lists 2 recalls naming amitriptyline since 2017: 0 Class I (the most serious), 1 Class II, 1 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 16, 2017 | Class III | Sandoz Incorporated | Cross Contamination With Other Product: Imipramine |
| April 20, 2017 | Class II | C. O. Truxton | Labeling: Label Mixup; potentially mislabeled |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the amitriptyline label say about other medicines?
The amitriptyline label names 16 other medicines in its interaction, contraindication or warning sections. The labels of 35 other medicines name amitriptyline. 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 | … drugs (including triptans, tricyclic antidepressants, SSRI/SNRI, 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 | 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). |
| Disulfiram | drug interactions | Guanethidine or similarly acting compounds; thyroid medication; alcohol, barbiturates and other CNS depressants; and disulfiram – see WARNINGS section. |
| Epinephrine | drug interactions | When amitriptyline is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required. |
| Fentanyl | warnings | … with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, SSRI/SNRI, 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 | 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. |
| Linezolid | warnings | … serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| Lithium | warnings | … concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, SSRI/SNRI, 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 … |
| Methylene blue | warnings | … MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). |
| 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. |
| 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. |
Every other medicine the amitriptyline label names
| Medicine named | Section | What the label says |
|---|---|---|
| Topiramate | drug interactions | Drug Interactions Topiramate Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate and any adjustments in amitriptyline dose should be made … |
| Tramadol | warnings | … triptans, tricyclic antidepressants, SSRI/SNRI, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both … |
Other labels that name amitriptyline
Source: FDA drug label (Amitriptyline Hydrochloride), Sun Pharmaceutical Industries, Inc., effective September 8, 2026 (SPL set 4e520c63-1cf6-40f6-a51c-3f9b0e181342), via openFDA; the full label on DailyMed
What do FAERS reports show for amitriptyline?
The FDA Adverse Event Reporting System holds 17,441 reports that list amitriptyline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,314 are coded as a death and 5,755 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 amitriptyline?
30 other medicines are given the same way (oral) and in the same FDA class as amitriptyline 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 |
|---|---|---|---|---|
| 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 |
| Imipramine | Depression | 14 labelers | $0.0698 per tablet 10 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 amitriptyline
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does amitriptyline compare with medicines for the same use?
15 side-by-side pages set amitriptyline beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to amitriptyline
- 30 medicines for the same use
- Other tricyclic antidepressants
- the pharmacologic class, with prices and generics
- Amitriptyline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other