Prescription medication · Tricyclic Antidepressant (TCA)
amitriptyline
Also sold as Elavil. Amitriptyline is used to relieve the symptoms of depression.
Data updated 2026-05-15
- 16,403
- FDA reportsModerately reported
- 21
- InteractionsSeveral interactions
- $0.03
- Generic price (NADAC)
What the data shows
amitriptyline (Elavil) is a prescription Tricyclic Antidepressant (TCA), reported at a middle-of-the-pack volume (16,403 FDA reports), with 21 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
amitriptyline (Elavil) is a prescription Tricyclic Antidepressant (TCA). Amitriptyline is used to relieve the symptoms of depression.
Amitriptyline is a medicine used to treat depression. It may take up to 30 days to feel the full effect.
Verify with FDA → · CMS NADAC pricing →
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 →
NADAC price trail: AMITRIPTYLINE HCL 10 MG TAB
Same CMS presentation as the headline generic unit price above (4 effective dates). Adjacent % compares consecutive NADAC releases for this description only, not a patient out-of-pocket quote. Latest step: -17.5% vs prior release.
| Effective | NADAC / unit | vs prior | NDCs |
|---|---|---|---|
| February 21, 2024 | $0.0404/EA | - | 2 |
| April 17, 2024 | $0.0339/EA | -16.2% | 1 |
| August 21, 2024 | $0.0398/EA | +17.7% | 2 |
| December 18, 2024 | $0.0329/EA | -17.5% | 20 |
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.
The sections below are summarized in plain English from amitriptyline's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
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.
Side Effects (from patient reports)
Based on 16,403 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for amitriptyline, by number of reports
- Pain
Pain
1,565 reports
- Nausea
Nausea
1,434 reports
- Headache
Headache
1,381 reports
- Fatigue
Fatigue
1,371 reports
- Dyspnoea
Dyspnoea
1,340 reports
- Dizziness
Dizziness
1,153 reports
- Diarrhoea
Diarrhoea
1,087 reports
- Malaise
Malaise
1,031 reports
- Fall
Fall
1,013 reports
- Vomiting
Vomiting
984 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for amitriptyline each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where amitriptyline sits
amitriptyline has more FDA adverse-event reports than 51% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is amitriptyline; the line is the median (50th percentile).
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
Reports Mentioning Death
1,235
7.5% of reports — not proof of cause
Hospitalization Reports
5,471
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
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 |
| 12 | ARTHRALGIA | 922 |
| 13 | COGNITIVE DISORDER | 921 |
| 15 | ANXIETY | 817 |
| 16 | PRURITUS | 806 |
| 17 | INSOMNIA | 779 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: 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...
Mechanism: Amitriptyline causes a very small increase in risperidone levels in the body, but the change is not large enough to be significant.
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.
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.
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.
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.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I stop taking amitriptyline suddenly?
How long does it take for amitriptyline to work?
Can I drink alcohol while taking amitriptyline?
What should I do if I experience side effects?
Can amitriptyline be used for children?
Will amitriptyline make me gain weight?
Can I take other medications with amitriptyline?
What time of day should I take amitriptyline?
Is amitriptyline addictive?
What should I do if I think I have overdosed?
What are the common side effects of amitriptyline?
Does amitriptyline interact with other medications?
What drug class is amitriptyline?
What pregnancy or breastfeeding source fields are listed for amitriptyline?
Related Medications in Tricyclic Antidepressant (TCA)
Other drugs grouped near amitriptyline - same-class peers and common alternatives.
acamprosate
Campral
Acamprosate is a medicine that can help you stay away from alcohol if you are alcohol-dependent and have already stopped drinking.
Compare with amitriptyline →
alprazolam
Xanax
Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
Compare with amitriptyline →
amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
Compare with amitriptyline →
aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
Compare with amitriptyline →
asenapine
Saphris
Asenapine (Saphris) is an antipsychotic medicine.
Compare with amitriptyline →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for amitriptyline: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 16,403.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.53%.
- mepolizumab Δ 0.01 pts · 47,215 reports · Anti-IL-5 Monoclonal Antibody 7.52%death share
- ivabradine Δ 0.03 pts · 6,539 reports · HCN Channel Blocker 7.55%death share
- irbesartan Δ 0.05 pts · 43,004 reports · Angiotensin II Receptor Blocker (ARB) 7.48%death share
- baclofen Δ 0.09 pts · 83,476 reports · GABA-B Agonist (Muscle Relaxant) 7.44%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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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 16,403 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 are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
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. This registry does not provide medication decisions.
Last updated: June 12, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages