Amitriptyline: uses, dosing, side effects & brands
Amitriptyline is a tricyclic antidepressant sold in the U.S. under 2 brand and generic names, for depressive disorder and pain. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Tricyclic Antidepressant
- Treats
- Depressive Disorder and Pain
- Available as
- Tablet
- Sold as
- 2 products — Elavil and Amitriptyline Hydrochloride
- Prescription?
- Prescription only
- Generic available?
- Yes
- What the pharmacy pays
- about $3 for a 30-count supply — not your price
- Boxed warning
- Boxed warning
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How amitriptyline is dosed
From the FDA label for Amitriptyline Hydrochloride (application ANDA085968). Other amitriptyline products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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…
Amitriptyline side effects
Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered. Cardiovascular Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation. CNS and Neuromuscular Coma; seizures; hallucinations; delusions; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling and paresthesias of the extremities; extrapyramidal symptoms including abnormal involuntary movements and tardive dyskinesia; dysarthria; disturbed concentration; excitement; anxiety; insomnia; restlessness; nightmares; drowsiness; dizziness; weakness; fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns. Anticholinergic Paralytic ileus, hyperpyrexia; urinary retention, dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased ocular pressure, mydriasis; dry mouth. Allergic Skin rash; urticaria;…
Who shouldn’t take amitriptyline
Amitriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia. This drug is not recommended for use during the acute recovery phase following myocardial infarction.
Amitriptyline 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. 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). Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be coadministered with another drug known to be an inhibitor of P450 2D6. Monoamine oxidase inhibitors – see CONTRAINDICATIONS section. Guanethidine or similarly acting compounds; thyroid medication; alcohol, barbiturates and other CNS depressants; and disulfiram – see WARNINGS section. When amitriptyline hydrochloride 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 amitriptyline hydrochloride is administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather. Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic-type drugs. 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. Caution is advised if patients receive large doses of ethchlorvynol concurrently. Transient delirium has been reported in patients who were treated with one gram of ethchlorvynol and 75 to 150 mg of amitriptyline hydrochloride.
Every amitriptyline product we track (2)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Pharmacy pays | |
|---|---|---|---|---|---|---|---|
| 1 | 70/100 | Prescription | Tablet | Generic | $3 | View → | |
| 2 | 68/100 | Prescription | Tablet | Generic | $3 | View → |
What amitriptyline pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
Combination products containing amitriptyline
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
How long amitriptyline keeps
No amitriptyline label we read sets a separate limit for after opening, but they do specify how it must be stored — and the stability behind any date assumes those conditions.
Does amitriptyline expire? The in-use limits and storage rules from its labelsAmitriptyline and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for amitriptyline: levels in milk, effects in breastfed infants, and the drugs it would consider insteadMilk levels of amitriptyline and its metabolites are low. Immediate side effects have not been reported and a limited amount of follow-up has found no adverse effects on infant growth and development. Amitriptyline use during breastfeeding would usually not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. A safety scoring system finds amitriptyline use to be possible with caution during breastfeeding. However, rare sedation has been reported in a neonate. Other agents with fewer active metabolites may be preferred when large doses are required or while nursing a newborn or preterm infant.
National Institute of Child Health and Human Development, record revised August 15, 2024. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about amitriptyline
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 18,314 reports naming amitriptyline, and the FDA flagged 80% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- nausea1,576 reports
- headache1,513 reports
- dyspnoea1,484 reports
- fatigue1,482 reports
- dizziness1,254 reports
- diarrhoea1,211 reports
- malaise1,146 reports
- fall1,134 reports
Read these as a signal, not a rate. A report does not mean amitriptyline caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved August 25, 2026.
Is amitriptyline safe during pregnancy?
The label says use only if clearly needed
The label classifies amitriptyline as Pregnancy Category C. It states there are no adequate and well-controlled studies in pregnant women. Animal studies found it teratogenic in mice and hamsters at high doses (producing malformations), and it crosses the placenta. The label notes a few reports of adverse events — including CNS effects, limb deformities, or developmental delay — in infants whose mothers had taken amitriptyline during pregnancy, though a causal relationship has not been established. It advises that amitriptyline should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Discuss use in pregnancy with your prescriber.
This is what amitriptyline’s FDA label says — not a recommendation to take or stop it. In pregnancy, that decision is your prescriber’s; do not start or stop a medicine on your own.
Amitriptyline Hydrochloride — DailyMed FDA label ↗Does amitriptyline cause weight gain?
The label reports weight changes both ways
Under Adverse Reactions, the label lists "weight gain or loss" (in the "Other" category), so it names both directions of weight change as possible adverse reactions. No frequency or rate is given, and the label does not characterize one as more likely than the other.
Only what the FDA label reports — many drugs blamed for weight change online have no weight effect in their label, and we say so rather than repeat the folklore.
Amitriptyline Hydrochloride — DailyMed FDA label ↗Related guides
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Frequently asked questions
What is amitriptyline?
Amitriptyline Hydrochloride is a tricyclic antidepressant used to treat Depressive Disorder, Pain.
What kind of drug is amitriptyline?
The FDA classifies amitriptyline as a tricyclic antidepressant. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Is amitriptyline safe during pregnancy?
The label classifies amitriptyline as Pregnancy Category C. It states there are no adequate and well-controlled studies in pregnant women. Animal studies found it teratogenic in mice and hamsters at high doses (producing malformations), and it crosses the placenta. The label notes a few reports of adverse events — including CNS effects, limb deformities, or developmental delay — in infants whose mothers had taken amitriptyline during pregnancy, though a causal relationship has not been established. It advises that amitriptyline should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. Discuss use in pregnancy with your prescriber. This is what amitriptyline's FDA label says; whether to use it in pregnancy is your prescriber's decision.
Does amitriptyline cause weight gain?
Under Adverse Reactions, the label lists "weight gain or loss" (in the "Other" category), so it names both directions of weight change as possible adverse reactions. No frequency or rate is given, and the label does not characterize one as more likely than the other.
Can you take amitriptyline with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run amitriptyline against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What brand names is amitriptyline sold under?
We track 2 amitriptyline-containing products in the U.S.: Elavil and Amitriptyline Hydrochloride. They are the same active ingredient; they differ in form, manufacturer, price and FDA recall record.
What forms does amitriptyline come in?
Across the brands we track, amitriptyline is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic amitriptyline?
Yes. Our catalog lists 1 generic amitriptyline product alongside the brand versions. A generic has the same active ingredient and must meet the FDA's bioequivalence standard; it usually costs less. Ask your pharmacist which one your plan covers.
What is amitriptyline used for?
Amitriptyline is a tricyclic antidepressant, and its only FDA-approved use is treating depression. It works by increasing levels of the brain chemicals serotonin and norepinephrine, which help regulate mood. Because newer antidepressants generally have fewer side effects, amitriptyline is now prescribed for depression less often than it once was.
Is amitriptyline used for nerve pain or migraines?
Yes, but off-label — these are not FDA-approved uses. At low doses, amitriptyline is widely prescribed off-label for nerve (neuropathic) pain, chronic pain, fibromyalgia, and to prevent migraine and tension headaches. The doses used for pain are usually much lower than antidepressant doses, and the pain-relieving effect works differently from its mood effect. It's also used off-label at low doses for insomnia.
Who should be cautious with amitriptyline?
Amitriptyline carries a boxed warning that antidepressants can increase suicidal thoughts in people under 25, so close monitoring is advised early in treatment. It can also cause drowsiness, dry mouth, constipation, and heart rhythm effects, and the FDA label warns against use shortly after a heart attack. Older adults are more sensitive to its side effects.
Cite this page
- APA
- pharmaranks. (2026, July 24). Amitriptyline: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/amitriptyline
- MLA
- “Amitriptyline: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/amitriptyline.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for amitriptyline on DailyMed (NIH) ↗ — including its boxed warning in full.