Amitriptyline
Amitriptyline hydrochloride · Say it: am-ih-TRIP-tuh-leen hye-droh-KLOR-ide
Amitriptyline is a prescription antidepressant tablet used to relieve the symptoms of depression.
⬛ Boxed warning (the FDA's strongest warning)
Antidepressants can increase the risk of suicidal thoughts and behavior (suicidality) in children, adolescents, and young adults, especially in short-term studies. Anyone thinking about using this medicine or another antidepressant for a child, adolescent, or young adult must weigh this risk against the need for treatment. Depression and certain other psychiatric disorders also raise the risk of suicide. People of all ages who start antidepressant treatment should be watched closely for worsening mood, suicidal thoughts, or unusual behavior changes, and families and caregivers should stay in close contact with the prescriber. The label also states that amitriptyline is not approved for use in pediatric patients.
Used for
Relief of symptoms of depression. The label says endogenous depression is more likely to improve with this medicine than other depressive states.
Comes as
Tablets for oral use, available in 10, 25, 50, 75, 100, and 150 mg strengths; The label describes 75 mg tablets as purple, round, and marked with "45" on one side. They come in bottles with a child-resistant closure.
Common side effects
Drowsiness, Dizziness, Dry mouth
| Generic name | Amitriptyline hydrochloride |
|---|---|
| Brand names | — |
| Type of medicine | An antidepressant of the tricyclic type |
| How it is sold | Prescription tablet taken by mouth |
| Comes as | Tablets for oral use, available in 10, 25, 50, 75, 100, and 150 mg strengths; The label describes 75 mg tablets as purple, round, and marked with "45" on one side. They come in bottles with a child-resistant closure. |
| Route | oral |
| Boxed warning | Yes, see below |
| Label date | 2026-01-23 |
💊 What is Amitriptyline used for?
- Relief of symptoms of depression. The label says endogenous depression is more likely to improve with this medicine than other depressive states.
How it works
How it is usually taken
- The label says the dose is usually started low and increased slowly, with close attention to how the person responds and any side effects.
- The label says the dose may be split across the day, and that dose increases are preferably made in the late afternoon or at bedtime.
- For maintenance treatment, the label says the daily amount may be taken as a single dose, preferably at bedtime.
- The label says a calming (sedative) effect may appear before the antidepressant effect, and that the full benefit can take as long as 30 days to develop.
- The label says that once symptoms improve, the dose should be lowered to the least amount that keeps symptoms under control, and that maintenance therapy often continues for 3 months or longer to lower the chance of depression returning.
- Follow the instructions from your prescriber or pharmacist about how and when to take it.
Comes as
- Tablets for oral use, available in 10, 25, 50, 75, 100, and 150 mg strengths
- The label describes 75 mg tablets as purple, round, and marked with "45" on one side. They come in bottles with a child-resistant closure.
⚠️ Amitriptyline side effects
Common side effects
- Drowsiness
- Dizziness
- Dry mouth
- Constipation
- Blurred vision
- Nausea
- Headache
- Insomnia (trouble sleeping)
- Restlessness or nightmares
- Increased sweating
- Weight gain or weight loss
- Trouble urinating (urinary retention)
- Changes in appetite or taste
Get medical help right away if
- Get medical help right away if you have thoughts about suicide or dying, attempt suicide, or have new or worse depression, anxiety, panic attacks, agitation, restlessness, irritability, trouble sleeping, aggression, dangerous impulses, or an extreme increase in activity and talking (mania). The label says to call the healthcare provider right away for these changes.
- Get medical help right away if you have symptoms of low blood sodium, such as headache, weakness or feeling unsteady, or confusion, trouble concentrating, or memory problems. The label says older adults may be at greater risk.
- Get medical help right away if you have eye pain, changes in vision, or swelling or redness in or around the eye.
- Get medical help right away if you have signs of serotonin syndrome, which the label says can be life-threatening. These include agitation, hallucinations, coma or other mental status changes, racing heartbeat, high or low blood pressure, coordination problems or muscle twitching, nausea, vomiting, or diarrhea, sweating or fever, and muscle rigidity.
🛑 Who should not take Amitriptyline, and who should be careful
The label says not to take it if
- You have had a past allergic reaction (hypersensitivity) to amitriptyline. The label says it is contraindicated in this case.
- You take a monoamine oxidase inhibitor (MAOI). The label says the two should not be given together, and at least 14 days should pass after stopping an MAOI before starting amitriptyline.
- You take cisapride. The label says it should not be given with amitriptyline because of the risk of heart rhythm problems.
- You are in the acute recovery phase after a heart attack (myocardial infarction). The label says this drug is not recommended in that situation.
Tell your doctor before taking it if
- Tell your healthcare provider about all medicines you take, including over-the-counter products. The label says to keep a list to show your provider and not to start new medicines without checking first.
- Tell your healthcare provider if you have had low sodium levels in your blood during treatment.
- Do not stop this medicine suddenly without first talking to your healthcare provider. The label says stopping suddenly can cause other symptoms.
- The label says you may want an eye exam to see whether you are at risk for vision problems, and that preventive treatment is available if you are.
- The label says it is not recommended for children under 12 years of age.
- Older adults and adolescents may need lower doses, according to the label.
🔀 Amitriptyline with other medicines, food and alcohol
The label says to discuss these with your doctor or pharmacist
- Monoamine oxidase inhibitors (MAOIs): The label says they must not be given together with amitriptyline. Serious reactions, including high fever, severe seizures, and deaths, have occurred when they were combined.
- Cisapride: The label says it should not be given with amitriptyline because of the risk of increased QT interval and arrhythmia.
- Topiramate: The label says some patients may have a large increase in amitriptyline levels when taking topiramate. Dose changes should be based on clinical response, not blood levels.
- Medicines that affect the liver enzyme CYP2D6: The label says some drugs, including quinidine, cimetidine, phenothiazines, propafenone, flecainide, and many other antidepressants, can raise amitriptyline levels and may cause toxicity in someone who was stable before. Examples of SSRIs named include fluoxetine, sertraline, and paroxetine. The label says caution is needed when combining these with amitriptyline or switching between them.
- Fluoxetine: The label says enough time must pass before starting amitriptyline after fluoxetine is stopped, and that at least 5 weeks may be necessary.
- The label says that when a CYP2D6-inhibiting drug is stopped, the amitriptyline level may change, so the prescriber may need to adjust treatment.
Alcohol and food
The label does not say.
🤰 Amitriptyline in pregnancy and breastfeeding
Pregnancy
The label does not say.
Breastfeeding
The label does not say.
🗓️ Storage, missed doses and taking too much
Storage
The label does not say.
If a dose is missed
The label does not say.
If too much is taken
The label says deaths can occur from overdose with this class of medicine, and that taking several drugs together, including alcohol, is common in deliberate overdose. Symptoms can appear quickly, so the label says hospital monitoring is needed as soon as possible. Critical effects listed include heart rhythm problems, severe low blood pressure, seizures, and central nervous system depression, including coma. If someone may have taken too much, get emergency medical help right away and contact a poison control center.
🗒️ Questions to ask about Amitriptyline
🎯 Check what you understood
1. According to the label, which medicine should NOT be taken with amitriptyline?
2. What does the label say about the time it may take for the full antidepressant effect to develop?
3. What does the label say to do before stopping this medicine?
❓ Amitriptyline: frequently asked questions
What is amitriptyline used for?
The label says it is used for the relief of symptoms of depression. It is noted that endogenous depression is more likely to be alleviated than other depressive states.
Is amitriptyline approved for children?
The label says amitriptyline is not approved for use in pediatric patients and is not recommended for patients under 12 years of age. It also carries a boxed warning about suicidal thoughts in young people.
What should I do if I think someone has taken too much?
The label says overdose can be serious and symptoms can develop quickly. Get emergency medical help right away and contact a poison control center.
Can amitriptyline be taken with an MAOI?
No. The label says it should not be given with monoamine oxidase inhibitors, and at least 14 days should pass after stopping an MAOI before starting amitriptyline.
Why might I need an eye exam?
The label says only some people are at risk for certain vision problems, and an eye exam can show whether you are at risk and whether preventive treatment is needed.
🧪 Tests and reports linked to Amitriptyline
The label text mentions these. If you have one of these reports, get every line of it explained.
- Kidney function tests
a test or report linked to this medicine
- Metabolic panel (BMP, CMP)
a test or report linked to this medicine
- ECG (EKG) reports
a test or report linked to this medicine
- Echocardiogram reports
a test or report linked to this medicine
- Vitamin D test
a test or report linked to this medicine
- Pregnancy hCG test
a test or report linked to this medicine
📖 Medical words used on this page
- Acute vs chronic
Acute means something started recently or suddenly. Chronic means it has lasted a long time or keeps coming back.
- Allergic reaction
An allergic reaction is when the immune system overreacts to something harmless, such as a medicine or food, causing symptoms from a rash to swelling.
- Antidepressant
An antidepressant is a medicine used to treat depression, and often anxiety, pain and other conditions, by acting on chemical messengers in the brain.
- Arrhythmia
An arrhythmia is a heartbeat that is too fast, too slow or irregular, because the heart's electrical signals are not working in their usual pattern.
- Bilateral and unilateral
Bilateral means on both sides of the body and unilateral means on one side only, and reports usually also name the side.
- Boxed warning
A boxed warning is the strongest safety warning on a US medicine label, printed in a box, about a serious or life-threatening risk.
- CNS depressant
A CNS depressant is any medicine or substance that slows down brain and nerve activity, causing drowsiness, relaxation or slower breathing.
- Contraindication
A contraindication is a reason not to use a particular medicine, test or procedure for a person because it could cause harm.
- Edema
Edema is swelling caused by extra fluid trapped in the body's tissues, often in the feet, ankles and legs.
- Exacerbation
An exacerbation is a flare-up: a period when a long-term condition, such as asthma, COPD or hepatitis, suddenly gets worse.
- Hypersensitivity
Hypersensitivity means the immune system overreacts to something, such as a medicine. It covers allergic reactions from mild rash to severe reactions.
- Hyponatremia
Hyponatremia means the level of sodium (salt) in the blood is lower than expected. Some medicines can cause it.
- Hypotension
Hypotension means low blood pressure. It can cause dizziness or fainting, and some medicines can lower blood pressure too far.
- Maintenance Therapy
Maintenance therapy is ongoing treatment taken to keep a condition under control or stop it coming back, rather than to treat a sudden flare.
📖 Medical words on this page
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Have the leaflet or prescription in front of you?
Explain my leafletDecode my prescription🔗 Trusted sources about Amitriptyline
- Full official label on DailyMed ↗
US National Library of Medicine: the complete FDA label this page is based on
- Amitriptyline on MedlinePlus ↗
US National Library of Medicine's patient drug information
- Search the NHS website for Amitriptyline ↗
UK National Health Service
Report a side effect or check safety alerts
- Report a side effect in the US (FDA MedWatch) ↗
- Report a side effect in the UK (Yellow Card) ↗
- FDA recalls and safety alerts ↗
Explain your own documents
Source: official FDA drug label (label updated 2026-01-23). Read the full label on DailyMed
MedicDecode explains the official label in plain words. It is not medical advice and does not replace your doctor or pharmacist. Never start, stop or change a medicine because of what you read here.