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Amitriptyline

Amitriptyline is a tricyclic antidepressant taken by mouth as a tablet to relieve symptoms of depression.

Brand names AmitidAmitrilElavilEndep
Drug class Tricyclic Antidepressant
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 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 142 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 →

✓No current FDA shortage listed · checked Oct 6, 2026
Amitriptyline at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Amitriptyline (Elavil) is an older tricyclic antidepressant for depression that keeps two brain chemicals, serotonin and norepinephrine, active longer; on the U.S. market since about 1977 and available as a generic, it is now usually a second choice behind newer antidepressants. It is quite sedating, and drowsiness, dizziness, dry mouth and constipation are what most people notice, often before the mood lifts, which can take up to about 30 days. Its boxed warning covers suicidal thoughts and behavior in children, teens and young adults, so watch for worsening mood or unusual behavior, especially early on, and report it right away. Never stop it suddenly; ask your prescriber how to taper.

Clinical pearls

  • Dose increases usually go into the bedtime dose, and many people end up taking it once daily at bedtime.
  • Never combine it with an MAOI; allow at least 14 days after stopping one, and about 5 weeks after fluoxetine.
  • Topiramate, SSRIs such as paroxetine, cimetidine and some heart rhythm drugs can push amitriptyline levels up, so have new prescriptions checked.
  • Alcohol, sleep aids and other sedating medicines stack onto its drowsiness, so go easy until you know how it affects you.
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Antidepressants, including amitriptyline, can increase suicidal thoughts and behavior in children, teens and young adults. This was seen in short-term studies in people up to age 24. Adults older than 24 did not show an increase, and adults 65 and older had a lower risk.

Depression itself also raises suicide risk. Anyone starting an antidepressant should be watched closely for worsening mood, suicidal thoughts or unusual behavior changes. Families and caregivers should stay in close contact with the prescriber. Amitriptyline tablets are not approved for children.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet
Earliest FDA record1961
Companies listing it with the FDA33
FDA label last updatedJan 9, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Amitriptyline, written from its FDA label.

What Amitriptyline is used for

▾

Amitriptyline tablets have one supported use across the products.

  • Amitriptyline HCL and Amitriptyline Hydrochloride oral tablets: relief of symptoms of depression.
  • Endogenous depression is more likely to improve than other depressive states.

How Amitriptyline works

▾

Amitriptyline is an antidepressant with sedative effects. It blocks the pump that lets nerve cells take back norepinephrine and serotonin. This may prolong the activity of these chemicals. Its exact mechanism in people is not known.

Amitriptyline dosage

▾

Amitriptyline tablets are taken by mouth. Treatment starts at a low level and is raised slowly based on response and tolerance.

  • Doses may be divided through the day at first.
  • Increases are often made in the late afternoon or bedtime dose.
  • Maintenance may be a single dose at bedtime.
  • Once you feel better, the dose is lowered to the lowest amount that keeps symptoms away. Treatment often continues 3 months or longer to reduce relapse.

Follow your prescriber and label directions.

Dosing details from the FDA-approved label

From the Amitriptyline 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 (initial dosage for adults)
    • 75 mg of amitriptyline hydrochloride a day in divided doses is usually satisfactory
    • If necessary, may be increased to a total of 150 mg per day
    • Maximum: 150 mg per day
    • Increases are made preferably in the late afternoon and/or bedtime doses; an adequate therapeutic effect may take as long as 30 days to develop
  • Outpatients (alternate method of initiating therapy)
    • Begin with 50 mg to 100 mg amitriptyline hydrochloride at bedtime
    • May be increased by 25 mg or 50 mg as necessary in the bedtime dose to a total of 150 mg per day
    • Maximum: 150 mg per day
  • Hospitalized patients
    • 100 mg a day initially
    • Can be increased gradually to 200 mg a day if necessary
    • Maximum: A small number of hospitalized patients may need as much as 300 mg a day
  • Adolescent and elderly patients
    • Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in patients who do not tolerate higher dosages
    • In general, lower dosages are recommended; elderly patients should be monitored carefully because plasma levels are generally higher for a given oral dose
  • Maintenance
    • The usual maintenance dosage is 50 to 100 mg per day
    • In some patients, 40 mg per day is sufficient
    • Total daily dosage may be given in a single dose, preferably at bedtime
    • Reduce to the lowest amount that will maintain relief of symptoms; continue maintenance therapy 3 months or longer to lessen the possibility of relapse
  • Pediatric patients under 12 years of age
    • Not recommended at the present time
    • Due to lack of experience with the use of this drug in pediatric patients
Read the label’s full dosing text

DOSAGE AND ADMINISTRATION Oral Dosage Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Initial Dosage for Adults For outpatients, 75 mg of amitriptyline hydrochloride a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop. An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline hydrochloride at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day. Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day. Adolescent and Elderly Patients In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages. Maintenance The usual maintenance dosage of amitriptyline hydrochloride is 50 to 100 mg per day. In some patients, 40 mg per day is sufficient. For maintenance therapy, the total daily dosage may be given in a single dose, preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer to lessen the possibility of relapse. Usage in Pediatric Patients In view of the lack of experience with the use of this drug in pediatric patients, it is not recommended at the present time for patients under 12 years of age. Plasma Levels Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Amitriptyline side effects

▾

Many side effects come from amitriptyline's effects on the nervous system.

Common side effects

  • Drowsiness
  • Dizziness
  • Dry mouth
  • Constipation
  • Blurred vision
  • Fatigue or weakness
  • Headache
  • Weight gain or loss

When to get medical help

  • Get help right away if you have new or worsening depression, suicidal thoughts, or unusual changes in behavior.
  • Seek urgent care for chest pain, fainting, a very fast or irregular heartbeat, or signs of stroke.
  • Call your doctor if you have seizures, hallucinations, confusion, or severe agitation.
  • Call your doctor for muscle rigidity with fever and confusion, which can signal a rare reaction resembling neuroleptic malignant syndrome.
  • Call your doctor if you have yellowing of the skin or eyes, or signs of infection such as fever or sore throat.
  • Seek help for swelling of the face or tongue, or a severe rash.
  • Call your doctor if you cannot urinate or have severe stomach swelling or constipation.
  • Uncontrolled muscle movements (tardive dyskinesia) should be reported.

Amitriptyline warnings and precautions

▾

Suicidality: Antidepressants can raise the risk of suicidal thoughts and behavior in children, teens and young adults. Watch for worsening mood or unusual behavior, especially early on.

  • Heart effects such as arrhythmias, low blood pressure on standing, and heart attack or stroke have been reported.
  • Abrupt stopping after long use can cause nausea, headache and malaise.
  • Rare reactions include a syndrome resembling neuroleptic malignant syndrome and serotonin syndrome.

Amitriptyline interactions

▾

Amitriptyline interacts with several drugs.

  • MAOIs: dangerous reactions including fever, severe convulsions and death.
  • Cisapride: risk of heart rhythm problems.
  • SSRIs, cimetidine, quinidine and other CYP2D6 inhibitors: can raise amitriptyline levels.
  • Topiramate: can greatly raise amitriptyline levels.
  • Anticholinergic and neuroleptic drugs: fever or bowel blockage.
  • Alcohol and other CNS depressants: extra sedation.

Interactions listed in the FDA-approved label

From the Amitriptyline prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Topiramate: Some patients may experience a large increase in amitriptyline concentration in the presence of topiramate. Adjust amitriptyline dose according to the patient's clinical response and not on the basis of plasma levels.
  • Drugs that inhibit cytochrome P450 2D6 (quinidine, cimetidine, many other antidepressants, phenothiazines, propafenone, flecainide): They can make normal metabolizers resemble poor metabolizers, and an individual stable on a given TCA dose may become abruptly toxic. May require lower doses than usually prescribed for either the TCA or the other drug; an increased TCA dose may be required when the other drug is withdrawn; monitor TCA plasma levels.
  • Selective serotonin reuptake inhibitors (SSRIs) e.g., fluoxetine, sertraline, paroxetine: All inhibit P450 2D6, though they may vary in the extent of inhibition. Caution is indicated in coadministration and in switching from one class to the other; sufficient time must elapse before initiating TCA in a patient withdrawn from fluoxetine (at least 5 weeks may be necessary).
  • Monoamine oxidase inhibitors: See CONTRAINDICATIONS section.
  • Guanethidine or similarly acting compounds; thyroid medication; alcohol, barbiturates and other CNS depressants; disulfiram: See WARNINGS section.
  • Anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics: Interaction with amitriptyline hydrochloride; paralytic ileus may occur with anticholinergic type drugs, and hyperpyrexia has been reported with anticholinergic agents. Close supervision and careful adjustment of dosages are required.
  • Neuroleptic drugs: Hyperpyrexia has been reported, particularly during hot weather.
  • Cimetidine: Reduces hepatic metabolism of certain tricyclic antidepressants, delaying elimination and increasing steady-state concentrations, plasma levels, and frequency and severity of side effects, particularly anticholinergic; discontinuing it may decrease plasma levels and efficacy of the antidepressants.
  • Ethchlorvynol: Transient delirium has been reported in patients treated with one gram of ethchlorvynol and 75 to 150 mg of amitriptyline hydrochloride. Caution is advised if patients receive large doses of ethchlorvynol concurrently.
Read the label’s full interactions text

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 according to the patient's clinical response and not on the basis of plasma levels. 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 interactions 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.

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 Amitriptyline

▾
  • Do not use if you are allergic to amitriptyline.
  • Do not use with MAOIs or cisapride.
  • Not recommended during the acute recovery phase after a heart attack.
  • Not approved for children; not recommended under age 12.
  • Adolescents and older adults generally need lower doses.

Amitriptyline overdose

▾

Overdose can be fatal. It can cause dangerous heart rhythm problems, very low blood pressure, seizures and coma, and signs can develop quickly. Seek emergency care and contact a poison control center right away. Overdose is often deliberate, so psychiatric follow-up may be appropriate.

What Amitriptyline does in the body

▾

Amitriptyline blocks reuptake of norepinephrine and serotonin in nerve cells, which may prolong their activity. It has a sedative effect that can appear before the antidepressant effect. It is not an MAOI and does not act mainly by stimulating the central nervous system.

How to store Amitriptyline

▾

Store amitriptyline hydrochloride tablets in a well-closed container. Store at 20° to 25°C (68° to 77°F) . Protect from light.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

296

Supplements & herbs that interact with Amitriptyline

296 supplements and herbal products have documented interactions with Amitriptyline in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 17
  • Moderate · 228
  • Minor · 51
Every supplement checked against Amitriptyline — ranked by severity The full interaction hub: 17 major · 228 moderate · 51 minor · every one linked to its full report. Check Amitriptyline against your exact supplements

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.

3

Nutrient depletion considerations

Amitriptyline 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.

Evidence & significance mix
  • Higher significance · 1
  • Moderate · 1
  • Unrated · 1
See the full Amitriptyline nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Amitriptyline: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Amitriptyline — the kind of thing our pharmacy team would talk through with you at the counter.

What is amitriptyline for?

▾
It's used to relieve symptoms of depression. It tends to work best for endogenous depression. Your prescriber can explain why it was chosen for you.

How long until I feel better?

▾
You may feel sleepy before your mood improves. Full benefit can take as long as 30 days. Keep taking it as directed and keep in touch with your prescriber.

When should I take it?

▾
It's taken by mouth, and your prescriber may split the dose or have you take it at bedtime. It can make you drowsy, so bedtime dosing is common. Follow your label directions.

Can I stop it if I feel better?

▾
Please don't stop suddenly. After long use, stopping abruptly can cause nausea, headache and malaise. Your prescriber will lower the dose gradually and often continues treatment for 3 months or longer to prevent relapse.

What side effects should I expect, and which are worrying?

▾
Drowsiness, dizziness, dry mouth, constipation and blurred vision are common. Call right away for chest pain, fainting, seizures, trouble urinating, or swelling of the face or tongue. Also call for any new suicidal thoughts or unusual behavior changes.

What should I avoid taking with it?

▾
Never combine it with MAOI antidepressants or cisapride. Tell me about any SSRIs, cimetidine, topiramate or other medicines you use. Alcohol and sedatives can add to drowsiness.

Is Amitriptyline available over the counter?

▾
No. Amitriptyline is a prescription medicine: every Amitriptyline product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Amitriptyline first available?

▾
The earliest FDA record we hold for Amitriptyline is from 1961: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Amitriptyline was first used.

Who makes Amitriptyline?

▾
33 companies currently list Amitriptyline products in the FDA's NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions, Remedyrepack Inc.. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Amitriptyline on HelloPharmacist

Detailed data & references for Amitriptyline Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Amitriptyline forms and strengths (how it comes)

Amitriptyline 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 Amitriptyline inactive ingredients by manufacturer.

Tablet

By mouth
How this form is used
What it may be used for
  • Amitriptyline HCL tablets are used to relieve symptoms of depression.
  • Amitriptyline Hydrochloride tablets are used to relieve symptoms of depression.
Important instructions
  • Amitriptyline HCL tablets are taken by mouth, started low and increased gradually.
  • Amitriptyline Hydrochloride tablets are taken by mouth, with maintenance often given as a single bedtime dose.
Available strengths 6 strengths
373 FDA-listed product records ⓘ

Amitriptyline on the U.S. market: products, makers and brands

How Amitriptyline 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.

33 companies list 209 Amitriptyline product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 1961. Brand names on the directory include Amitid, Amitril, Elavil and 1 more; the rest are generics.

1
Dose forms ⓘ
33
Labelers (makers, repackagers, distributors)
2
Brand names
209
FDA-listed product records ⓘ
1961
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (19) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack9%
A-S Medication Solutions8%
Remedyrepack Inc.5%
Preferred Pharmaceuticals Inc.4%
Aphena Pharma Solutions - Tennessee, LLC3%
Direct_Rx3%
Other makers67%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Amitriptyline is used (Medicaid data)

A general measure of how commonly Amitriptyline 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 Amitriptyline 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.

1,761,477
Medicaid prescriptions filled (Q1–Q4 2025)
$19M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Amitriptyline prescribed? Of the 1,601 medications we measure, Amitriptyline ranks #123 by Medicaid prescriptions — more than 92% of them.

Where Amitriptyline ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Amitriptyline 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.

The 25 mg oral tablet is the most-dispensed Amitriptyline product — about 35% of these Medicaid prescriptions.

amitriptyline hydrochloride 25 MG Oral Tablet Most dispensed

618,547 Medicaid prescriptions (Q1–Q4 2025) 35% of Amitriptyline prescriptions shown $6.1M gross reimbursement (before rebates) ≈ $9.90 per prescription (gross)

Summed across the 20 of 291 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 856834

amitriptyline hydrochloride 10 MG Oral Tablet

464,322 Medicaid prescriptions (Q1–Q4 2025) 26% of Amitriptyline prescriptions shown $4.3M gross reimbursement (before rebates) ≈ $9.33 per prescription (gross)

Summed across the 20 of 203 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 856783

amitriptyline hydrochloride 50 MG Oral Tablet

360,722 Medicaid prescriptions (Q1–Q4 2025) 20% of Amitriptyline prescriptions shown $4M gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 19 of 236 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 856845

amitriptyline hydrochloride 100 MG Oral Tablet

167,330 Medicaid prescriptions (Q1–Q4 2025) 9% of Amitriptyline prescriptions shown $2.5M gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 10 of 127 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 856762

amitriptyline hydrochloride 75 MG Oral Tablet

96,665 Medicaid prescriptions (Q1–Q4 2025) 5% of Amitriptyline prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $12 per prescription (gross)

Summed across the 9 of 97 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 856853

amitriptyline hydrochloride 150 MG Oral Tablet

53,891 Medicaid prescriptions (Q1–Q4 2025) 3% of Amitriptyline prescriptions shown $990,486 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 10 of 55 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 856773

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 Amitriptyline, 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 88 of 1,009 listed Amitriptyline NDCs with Medicaid activity.

Compare Amitriptyline products

A representative set of FDA-listed product records for Amitriptyline — 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.)

Showing 200 of 209 products — FDA National Drug Code Directory. See every product, package size and price: browse all 209 Amitriptyline NDCs →

Amitriptyline 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 Amitriptyline — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Amitriptyline are pain, nausea, headache; about 80% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

17,466
Reports mentioning it
80%
Reported as serious
12
Distinct effects shown
Most reported effects
Pain
1,657
Nausea
1,535
Headache
1,476
Fatigue
1,449
Dyspnoea
1,441
Dizziness
1,224
Diarrhoea
1,184
Malaise
1,100
Vomiting
1,063
Fall
1,053
Age groups
Adult · 1,822Elderly · 1,119Neonate · 27Adolescent · 27Child · 14Infant · 2

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 Amitriptyline 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.

Amitriptyline FDA approval history

How Amitriptyline went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Amitriptyline was first approved by the FDA in 1961 (Brand: ELAVIL · Astrazeneca); the first generic version was approved in 1976. It remains available in U.S. pharmacies today.

1961
Brand approved
Brand: ELAVIL · Astrazeneca
1976
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Amitriptyline 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 Amitriptyline recalls since July 2021.

✅No Amitriptyline recalls on record since July 2021

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.

Ingredient (IN) Amitriptyline RxCUI 704 3 dose forms · 10 strengths
  1. Dose form (SCDF) Extended Release Oral Capsule RxCUI 370863 No current FDA listing
    Clinical drug / strength (SCD) hydrochloride 25 MG RxCUI 856865 hydrochloride 50 MG RxCUI 856868
  2. Dose form (SCDF) Oral Solution RxCUI 370864 No current FDA listing
    Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 856862 hydrochloride 5 MG/ML RxCUI 856867

Look up RxCUI 704 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.

💵 What Amitriptyline 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.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 25 mg $0.052 per tablet NDC details & price history
Tablet, Film Coated · Oral 10 mg $0.030 per tablet NDC details & price history
Tablet, Film Coated · Oral 50 mg $0.096 per tablet NDC details & price history
Tablet, Film Coated · Oral 100 mg $0.143 per tablet NDC details & price history
Tablet, Film Coated · Oral 150 mg $0.290 per tablet NDC details & price history
Tablet, Film Coated · Oral 75 mg $0.123 per tablet NDC details & price history
Tablet · Oral 25 mg $0.052 per tablet NDC details & price history
Tablet · Oral 50 mg $0.096 per tablet NDC details & price history
Tablet · Oral 100 mg $0.143 per tablet NDC details & price history
Tablet · Oral 75 mg $0.123 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full 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.

Amitriptyline brand names

Amitriptyline is sold under 4 brand names in the FDA directory — Amitid, Amitril, Elavil, Endep. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Amitid Amitril Elavil Endep

Who makes Amitriptyline: manufacturers and labelers

33 companies list Amitriptyline products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, A-S Medication Solutions, Remedyrepack Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 18 A-S Medication Solutions 17 Remedyrepack Inc. 11 Preferred Pharmaceuticals Inc. 9 Aphena Pharma Solutions - Tennessee, LLC 7 Direct_Rx 7 Northwind Health Company, LLC 7 Advagen Pharma Ltd 6 AiPing Pharmaceutical, Inc. 6 Asclemed USA, Inc. 6 Centaur Pharmaceuticals Private Limited 6 Coupler LLC 6 Golden State Medical Supply, Inc. 6 Lifestar Pharma LLC 6 Northstar Rx LLC. 6 Rising Pharma Holdings, Inc. 6 St. Mary's Medical Park Pharmacy 6 Sandoz Inc 6 Sun Pharmaceutical Industries, Inc. 6 Unichem Pharmaceuticals (USA), Inc. 6 Westminster Pharmaceuticals, LLC 6 Zydus Lifesciences Limited 6 Zydus Pharmaceuticals USA Inc. 6 Advanced Rx of Tennessee, LLC 5

…and 9 more on the FDA NDC directory.

Amitriptyline drug class (RxNorm)

Amitriptyline belongs to the Tricyclic Antidepressant class.

Pharmacologic class Tricyclic Antidepressant
Drug family (ATC) Non-selective monoamine reuptake inhibitors

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 Amitriptyline 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.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jan 9, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Amitriptyline.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
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Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Amitriptyline after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
142
Finished products in the current FDA directory
209
Companies listing them (makers, repackagers, distributors)
33
FDA labeler codes behind them ⓘ
36
Linked representative label ⓘ
AvPAK
Linked label effective
Jan 9, 2025
Composite sections available
19
Linked SPL Set ID
fd771b4b-c7ae-8e69-e053-6294a90a2120
Linked SPL Document ID
2b489f9d-de0e-dd7a-e063-6394a90a8571
Open the linked representative label on DailyMed ↗

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. AvPAK 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 →