Prescription medicine
Protriptyline First approved as Vivactil
Protriptyline (Vivactil) is a prescription medicine with an FDA approval on record since 1967. FDA's NDC Directory lists it from 2 generic labelers, and pharmacies paid $2.71 per protriptyline HCl 10 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the protriptyline FDA label on DailyMed (effective July 25, 2023, Epic Pharma, LLC); the NDA 16012 record on Drugs@FDA; every protriptyline label on DailyMed.
Highlights of the record
FDA label of July 25, 2023; 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 protriptyline 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. Protriptyline 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 usageProtriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision.
Forms and strengths
- 5 mg
- 10 mg
Film-coated tablet.
On the market
- Earliest approval on file
- September 27, 1967 Vivactil, Teva Womens; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first August 24, 1995; 2 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 2 of which 2 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $2.71 per tablet Protriptyline HCl 10 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 96 through July 30, 2026
What is protriptyline used for?
From the label: indications and usageProtriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.
Conditions named in the indications of protriptyline's FDA labels, with every medicine labeled for each:
From other protriptyline labelsDepression: INDICATIONS AND USAGE Protriptyline hydrochloride tablets are indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision.
FDA pharmacologic class: Tricyclic Antidepressant.
Source: FDA drug label (Protriptyline Hydrochloride), Epic Pharma, LLC, effective July 25, 2023 (SPL set c6c7c39e-e510-4f4a-bf7a-926f0e075d3a), via openFDA; the full label on DailyMed
Is there a generic for protriptyline (Vivactil)?
The FDA approved the first generic protriptyline on August 24, 1995. 5 generic applications are approved; 2 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 protriptyline from 2 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.
- 1967 earliest approval on file
- 1995 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for protriptyline (Vivactil)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.71 per Protriptyline HCl 10 mg tablet, down 6% from $2.88 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.
- Protriptyline HCl 5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Protriptyline HCl 10 mg tablet | Generic | $2.71 per tablet | $81.33 | -6% |
| Protriptyline HCl 5 mg tablet | Generic | $2.62 per tablet | $78.55 | -7% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the protriptyline label say about other medicines?
The protriptyline label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name protriptyline. 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 | Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. |
| Epinephrine | drug interactions | Drug Interactions When protriptyline is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required. |
| Tramadol | drug interactions | Tricyclic antidepressants may enhance the seizure risk in patients taking ULTRAM (tramadol hydrochloride). |
Other labels that name protriptyline
Source: FDA drug label (Protriptyline Hydrochloride), Epic Pharma, LLC, effective July 25, 2023 (SPL set c6c7c39e-e510-4f4a-bf7a-926f0e075d3a), via openFDA; the full label on DailyMed
What do FAERS reports show for protriptyline?
The FDA Adverse Event Reporting System holds 96 reports that list protriptyline among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 24 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.
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 protriptyline?
30 other medicines are given the same way (oral) and in the same FDA class as protriptyline 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 |
| 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 |
| Bupropion | Depression | 73 labelers | $0.0785 per tablet 150 mg tablet | No current entry |
Every medicine labeled for the same conditions as protriptyline
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does protriptyline compare with medicines for the same use?
1 side-by-side page set protriptyline beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to protriptyline
- 30 medicines for the same use
- Other tricyclic antidepressants
- the pharmacologic class, with prices and generics
- Protriptyline side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other