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amitriptyline

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Brand names: Elavil

Tricyclic Antidepressant (TCA) Rx

Amitriptyline is a medicine used to treat depression. It may take up to 30 days to feel the full effect.

Drug Pricing (NADAC)

Generic Price

$0.03/unit

Generic Available

Yes (9 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

What it does

Amitriptyline is used to relieve the symptoms of depression.

Common side effects

Drowsiness, Dizziness, Weakness

Key warnings

Antidepressants may increase the risk of suicidal thoughts or actions in children, teens, and young adults.

How It Works

Amitriptyline belongs to a class of drugs called tricyclic antidepressants (TCAs). It works by increasing the levels of certain chemicals in your brain. These chemicals help improve your mood.

How to Take It

Start with a low dose and increase it slowly. For adults, the starting dose is usually 75 mg per day, divided into smaller doses. Your doctor may increase this to 150 mg per day if needed. Some people take 50 to 100 mg at bedtime.

Pregnancy & Breastfeeding

Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if amitriptyline will harm your unborn baby. Amitriptyline can pass into breast milk.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.

Storage

Store at room temperature away from moisture and heat.

Side Effects (from patient reports)

Based on 12,353 FDA adverse event reports.

Pain
1,564
Feeling sick to your stomach
1,434
Head pain
1,380
Tiredness
1,369
Shortness of breath
1,340
Feeling lightheaded
1,152
Loose stools
1,087
General discomfort
1,031
Falling down
1,012
Throwing up
984

FDA Adverse Event Report Analysis

Detailed analysis of 16,403 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

16,403

Death-Related Reports

1,235

Hospitalization Reports

5,471

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 10,711 (71%)
Male 4,363 (29%)

Age Distribution

0–17 316
18–44 2,403
45–64 4,766
65–74 2,285
75+ 2,180

Most Reported Adverse Reactions (FAERS)

# Reaction Reports
1 PAIN 1,565
2 NAUSEA 1,434
3 HEADACHE 1,381
4 FATIGUE 1,371
5 DYSPNOEA 1,340
6 DIZZINESS 1,153
7 DIARRHOEA 1,087
8 MALAISE 1,031
9 FALL 1,013
10 VOMITING 984
11 OFF LABEL USE 979
12 ARTHRALGIA 922
13 COGNITIVE DISORDER 921
14 DRUG INEFFECTIVE 869
15 ANXIETY 817

Reactions in Death Reports

COMPLETED SUICIDE 264
DEATH 210
TOXICITY TO VARIOUS AGENTS 155
CARDIO-RESPIRATORY ARREST 104
PNEUMONIA 58
DRUG ABUSE 55
CARDIAC ARREST 54
FATIGUE 54
PYREXIA 50
DYSPNOEA 49

Reactions in Hospitalization Reports

FALL 787
PAIN 781
HYPOTENSION 649
COGNITIVE DISORDER 591
CONSTIPATION 576
DYSPNOEA 542
TOXICITY TO VARIOUS AGENTS 542
BALANCE DISORDER 537
ORTHOSTATIC HYPOTENSION 498
DEPRESSED LEVEL OF CONSCIOUSNESS 474

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Antidepressants may increase the risk of suicidal thoughts or actions in children, teens, and young adults. Your doctor should closely monitor you for worsening depression or unusual changes in behavior. Amitriptyline is not approved for use in children.

Known Drug Interactions

Dose adjustment is not recommended for risperidone tablets when co-administered with ranitidine, cimetidine, amitriptyline, or erythromycin [see Table 18 ] . Do not exceed twice the patient’s usual dose Enzyme (CYP3A) inhibitors Ranitidine 150 mg twice daily 1 mg single dose 1.2 1.4 Dose adjustment not needed Cimetidine 400 mg twice daily 1 mg single dose 1.1 1.3 Dose adjustment not needed Erythromycin 500 mg four times daily 1 mg single dose 1.1 0.94 Dose adjustment not needed Other Drugs Amitriptyline 50 mg twice daily 3 mg twice daily 1.2 1.1 Dose adjustment not Needed *Change relative t...

Mechanism: Amitriptyline causes a very small increase in risperidone levels in the body, but the change is not large enough to be significant.

What to do: No dose adjustment is needed when these two medications are taken together.

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 slows down the liver's ability to process amitriptyline. This can cause amitriptyline to build up to higher levels in your body.

What to do: Your doctor may need to adjust your dose or watch you closely for increased side effects.

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. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).

Mechanism: Fluoxetine blocks the liver from breaking down amitriptyline and stays in the body for a very long time. This can cause amitriptyline levels to become too high even after you stop taking fluoxetine.

What to do: You should wait at least five weeks after stopping fluoxetine before you start taking amitriptyline.

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 interferes with the liver enzyme that clears amitriptyline from your body. This makes the amitriptyline stay in your blood longer than it should.

What to do: Your doctor should monitor you for side effects and may need to lower your amitriptyline dose.

Guanethidine or similarly acting compounds; thyroid medication; alcohol, barbiturates and other CNS depressants; and disulfiram – see WARNINGS section.

Mechanism: Disulfiram can interfere with how your liver breaks down amitriptyline. This can lead to higher levels of the medication in your system.

What to do: Use this combination with caution and follow your doctor's instructions for monitoring your symptoms.

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Common Questions

Can I stop taking amitriptyline suddenly?
No, do not stop taking amitriptyline suddenly. This can cause withdrawal symptoms like nausea and headache.
How long does it take for amitriptyline to work?
It may take up to 30 days to feel the full effects of amitriptyline.
Can I drink alcohol while taking amitriptyline?
Avoid alcohol while taking amitriptyline, as it can increase drowsiness.
What should I do if I experience side effects?
Tell your doctor if you experience any bothersome side effects.
Can amitriptyline be used for children?
Amitriptyline is not approved for use in children.
Will amitriptyline make me gain weight?
Weight gain is a possible side effect of amitriptyline.
Can I take other medications with amitriptyline?
Talk to your doctor about all the medicines you take, including over-the-counter drugs.
What time of day should I take amitriptyline?
Your doctor may recommend taking it at bedtime due to its sedative effects.
Is amitriptyline addictive?
Amitriptyline is not considered addictive, but stopping it suddenly can cause withdrawal symptoms.
What should I do if I think I have overdosed?
Seek immediate medical attention if you think you have overdosed.
What are the common side effects of amitriptyline?
The most commonly reported side effects of amitriptyline include Drowsiness, Dizziness, Weakness, Fatigue, Headache. Based on 12,353 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does amitriptyline interact with other medications?
Yes, amitriptyline has 21 known drug interactions. Notable interactions include risperidone, sertraline, fluoxetine. Always inform your doctor about all medications you are taking.
What drug class is amitriptyline?
amitriptyline belongs to the Tricyclic Antidepressant (TCA) drug class. It requires a prescription (Rx). Amitriptyline is used to relieve the symptoms of depression.
Is amitriptyline safe during pregnancy?
Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is not known if amitriptyline will harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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What the FDA Data Shows for amitriptyline

The FDA label for amitriptyline (sold under brand names such as Elavil) classifies it as a prescription-only medication in the Tricyclic Antidepressant (TCA) class. Amitriptyline is used to relieve the symptoms of depression. Official labeling lists 8 commonly reported side effects, including Drowsiness, Dizziness, Weakness.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 12,353 voluntary reports. The database also lists 21 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS shows a generic unit cost of $0.03.

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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: June 12, 2024

All federal data sources used on this page