Protriptyline
Protriptyline is a tricyclic antidepressant used to treat symptoms of depression, particularly in people who are withdrawn and low on energy.
🧬 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 2 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 →
Protriptyline (Vivactil) is an older tricyclic antidepressant, available generically and usually tried after newer antidepressants, for depression under close medical supervision; unlike most tricyclics it is energizing rather than sedating, which suits people who are withdrawn and low on energy. It is harder to tolerate than newer options, with anticholinergic (drying) effects such as dry mouth, constipation and blurred vision, heart effects like a fast heartbeat or dizziness on standing, and it can stir up anxiety. Its boxed warning covers suicidal thoughts and behavior in children, teens and young adults through age 24, so watch for worsening mood or unusual behavior, especially early on and after dose changes.
Clinical pearls
- Never combine it with an MAOI antidepressant, and allow at least 14 days after stopping one before starting protriptyline.
- Tell your dentist you take it, since epinephrine in local numbing shots needs extra care alongside this medicine.
- Skip over-the-counter cimetidine (Tagamet HB) for heartburn, since it raises protriptyline levels and side effects.
- It makes skin burn more easily in sunlight, so use sunscreen and protective clothing outdoors.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Antidepressants, including protriptyline, can increase suicidal thoughts and behavior in children, teenagers and young adults (through age 24). This was seen in short-term studies. It was not seen in adults over 24, and risk was lower in adults 65 and older.
Depression itself raises suicide risk. Patients of all ages should be monitored closely when starting treatment. Families and caregivers should watch for worsening depression, suicidal thinking or unusual behavior changes and contact the prescriber right away. Protriptyline is not approved for children.
Patient information guide A plain-language walkthrough of Protriptyline, written from its FDA label.
What Protriptyline is used for
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Protriptyline is used for one condition.
- Protriptyline Hydrochloride tablets (oral) treat symptoms of mental depression in patients under close medical supervision.
- Its activating properties make it particularly suitable for withdrawn and anergic (low-energy) patients.
How Protriptyline works
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Protriptyline is an antidepressant, but the exact way it works in people is not known. It is not an MAOI, and it does not act mainly by stimulating the central nervous system.
Protriptyline dosage
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Protriptyline tablets are taken by mouth, usually split into 3 or 4 doses a day. Treatment starts at a low level and is raised gradually while your prescriber watches your response and tolerance.
- Dose increases are made in the morning dose.
- Teens and older adults generally get lower doses.
- Once you improve, the dose is lowered to the smallest amount that keeps symptoms away.
- Minor side effects may call for a lower dose; major side effects or signs of allergy call for stopping the drug promptly.
Follow your prescriber and the label for your exact plan.
Dosing details from the FDA-approved label
From the Protriptyline 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.
- Usual Adult Dosage
- Fifteen to 40 mg a day divided into 3 or 4 doses
- If necessary, dosage may be increased to 60 mg a day
- Maximum: Dosages above 60 mg a day are not recommended
- Increases should be made in the morning dose; initiate at a low level and increase gradually
- Adolescent and Elderly Patients
- Five mg 3 times a day may be given initially, and increased gradually if necessary
- In general, lower dosages are recommended; in elderly patients, the cardiovascular system must be monitored closely if the daily dose exceeds 20 mg
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Usual Adult Dosage Fifteen to 40 mg a day divided into 3 or 4 doses. If necessary, dosage may be increased to 60 mg a day. Dosages above this amount are not recommended. Increases should be made in the morning dose. Adolescent and Elderly Patients In general, lower dosages are recommended for these patients. Five mg 3 times a day may be given initially, and increased gradually if necessary. In elderly patients, the cardiovascular system must be monitored closely if the daily dose exceeds 20 mg. When satisfactory improvement has been reached, dosage should be reduced to the smallest amount that will maintain relief of symptoms. Minor adverse reactions require reduction in dosage. Major adverse reactions or evidence of hypersensitivity require prompt discontinuation of the drug. The safety and effectiveness of protriptyline in pediatric patients have not been established.
Read the full Dosage and Administration section on DailyMed →
Protriptyline side effects
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Protriptyline can cause a range of side effects. Common ones include:
Common side effects
- Dry mouth
- Constipation
- Blurred vision
- Fast heartbeat or palpitations
- Dizziness, especially when standing up
- Drowsiness, weakness or fatigue
- Anxiety, agitation or restlessness
- Trouble urinating
- Fast heartbeat, palpitations, low blood pressure on standing
- Anxiety, restlessness, agitation, insomnia
- Nausea, urinary problems, weight changes
When to get medical help
- Call right away for new or worsening depression, suicidal thoughts, or unusual changes in behavior.
- Get emergency help for chest pain, signs of a stroke, or a very irregular or rapid heartbeat.
- Seek help for seizures, hallucinations, confusion or severe agitation.
- Tell your doctor about a skin rash, hives, or swelling of the face or tongue, which may be an allergic reaction.
- Report fever, sore throat or unusual bruising, which can signal blood problems.
- Report yellowing of the skin or eyes (jaundice).
- Seek help for eye pain or an inability to urinate.
- If you suspect an overdose, get emergency help or call poison control immediately.
Seek help for chest pain, stroke signs, seizures, confusion or hallucinations, allergic reactions, signs of blood disorders or jaundice.
Protriptyline warnings and precautions
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- Suicide risk: antidepressants raise the risk of suicidal thoughts and behavior in children, teens and young adults. Watch closely for worsening mood or unusual behavior.
- Heart: can cause fast heartbeat, low blood pressure, arrhythmias, and heart attack or stroke. Not for use right after a heart attack.
- Agitation: more likely to worsen anxiety and agitation.
- Sun: avoid excessive sunlight exposure.
- Stopping: abrupt stopping after long use may cause nausea, headache and malaise.
Protriptyline interactions
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Protriptyline can clash with several medicines.
- MAOIs: dangerous together, with high fever, severe convulsions and deaths reported.
- Cisapride: risk of heart rhythm problems.
- Cimetidine: raises protriptyline levels and side effects.
- Tramadol (Ultram): may increase seizure risk.
- Anticholinergics, neuroleptics: may cause high fever, especially in hot weather.
- Sympathomimetics, including epinephrine with local anesthetics: need close supervision.
- Alcohol, barbiturates, other CNS depressants: effects may be enhanced.
Interactions listed in the FDA-approved label
From the Protriptyline prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Anticholinergic agents: Hyperpyrexia has been reported when tricyclic antidepressants are administered with anticholinergic agents, particularly during hot weather. Close supervision and careful adjustment of dosages are required.
- Sympathomimetic drugs, including epinephrine combined with local anesthetics: The label states that giving protriptyline with these drugs requires close supervision. Close supervision and careful adjustment of dosages are required.
- Neuroleptic drugs: Hyperpyrexia has been reported when tricyclic antidepressants are administered with neuroleptic drugs, particularly during hot weather.
- Cimetidine: Cimetidine reduces hepatic metabolism of certain tricyclic antidepressants, delaying elimination and increasing steady-state concentrations, plasma levels and the frequency and severity of side-effects, particularly anticholinergic. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and cimetidine may decrease the plasma levels and efficacy of the antidepressants.
- ULTRAM (tramadol hydrochloride): Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.
- Alcohol: Protriptyline may enhance the response to alcohol.
- Barbiturates and other CNS depressants: Protriptyline may enhance the effects of barbiturates and other CNS depressants.
Read the label’s full interactions text
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. Hyperpyrexia has been reported when tricyclic antidepressants are administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather. Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side-effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and cimetidine may decrease the plasma levels and efficacy of the antidepressants. Tricyclic antidepressants may enhance the seizure risk in patients taking ULTRAM (tramadol hydrochloride). Protriptyline may enhance the response to alcohol and the effects of barbiturates and other CNS depressants.
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 Protriptyline
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- Do not use if you are allergic to protriptyline.
- Do not use with an MAOI; wait at least 14 days after stopping one.
- Do not use with cisapride.
- Do not use during the acute recovery phase after a heart attack.
- Not approved for children; safety and effectiveness are not established.
- Older adults and teens generally need lower doses; older adults need close heart monitoring at higher doses.
Protriptyline overdose
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Overdose with this class of drugs can be fatal, and signs develop rapidly. Serious effects include heart rhythm problems, severe low blood pressure, convulsions and coma. Get emergency help or call poison control immediately; hospital monitoring is needed as soon as possible.
What Protriptyline does in the body
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Protriptyline is an antidepressant that is not an MAOI and does not work mainly by stimulating the central nervous system. It lacks sedative and tranquilizing properties. Its activating effect is why it suits withdrawn, low-energy patients.
How your body processes Protriptyline
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In some studies protriptyline began working faster than imipramine or amitriptyline, with an initial clinical effect possible within one week. The rate of excretion is slow.
How to store Protriptyline
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Dispense in a tight container as defined in the USP. Store at 20°-25°C (68°-77°F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Protriptyline
93 supplements and herbal products have documented interactions with Protriptyline in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 71
- Minor · 18
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
Protriptyline 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.
Protriptyline: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Protriptyline — the kind of thing our pharmacy team would talk through with you at the counter.
What is protriptyline for?
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How should I take it?
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What side effects should I expect?
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When should I call my doctor right away?
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What shouldn't I mix with it?
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Is it safe for kids or older adults?
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Is Protriptyline available over the counter?
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When was Protriptyline first available?
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Who makes Protriptyline?
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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 Protriptyline on HelloPharmacist
Protriptyline forms and strengths (how it comes)
Protriptyline is available in 1 form. 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.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Protriptyline inactive ingredients by manufacturer.
Tablet
How this form is used
- Protriptyline Hydrochloride tablets are used to treat symptoms of mental depression in patients under close medical supervision.
- Protriptyline Hydrochloride tablets are taken by mouth, usually divided into 3 or 4 doses a day.
- Protriptyline Hydrochloride dosing starts low and increases gradually; any increases are made in the morning dose.
- Protriptyline Hydrochloride dose is reduced to the smallest amount that maintains relief once symptoms improve.
Protriptyline on the U.S. market: products, makers and brands
How Protriptyline 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.
2 companies list 4 Protriptyline product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1967. Brand names on the directory include Vivactil; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (4) — 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 Protriptyline is used (Medicaid data)
A general measure of how commonly Protriptyline 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 Protriptyline 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 Protriptyline prescribed? Of the 1,601 medications we measure, Protriptyline ranks #1,324 by Medicaid prescriptions — more than 17% of them.
Utilization by Protriptyline 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.
protriptyline hydrochloride 10 MG Oral Tablet Most dispensed
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 905168
protriptyline hydrochloride 5 MG Oral Tablet
Summed across the 2 of 6 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 905172
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 Protriptyline, 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 4 of 12 listed Protriptyline NDCs with Medicaid activity.
Compare Protriptyline products
A representative set of FDA-listed product records for Protriptyline — 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 |
|---|---|---|---|---|
| 💊Tablet | ||||
| 5 mg | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 10 mg | Oral | Epic Pharma, LLC | ANDA | View NDC → |
| 5 mg | Oral | Sigmapharm Laboratories, LLC | ANDA | View NDC → |
| 10 mg | Oral | Sigmapharm Laboratories, LLC | ANDA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Protriptyline NDCs →
Protriptyline 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 Protriptyline — 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 Protriptyline 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.
Protriptyline FDA approval history
How Protriptyline went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Protriptyline 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 no Protriptyline recalls since July 2021.
✅No Protriptyline recalls on record since July 2021Source: 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 8886 1 dose form · 2 strengths
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Dose form (SCDF) Oral Tablet RxCUI 373665In current FDA listings
Look up RxCUI 8886 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.
Protriptyline supply and shortage status
Whether Protriptyline 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 Protriptyline 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, Film Coated · Oral | 5 mg | $2.62 per tablet | NDC details & price history |
| Tablet, Film Coated · Oral | 10 mg | $2.71 per tablet | 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.
Protriptyline brand names
Protriptyline is sold under one brand name in the FDA directory — Vivactil. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Protriptyline: manufacturers and labelers
2 companies list Protriptyline products with the FDA. By number of product records, the largest are Epic Pharma, LLC, Sigmapharm Laboratories, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Protriptyline drug class (RxNorm)
Protriptyline 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 Protriptyline 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. Epic Pharma, LLC 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 →