Drug Notebook

FDA Alerts

    Suicidality
  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need. Amitriptyline is not approved for use in pediatric patients <12 years of age. (See Pediatric Use under Cautions.)
  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.
  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.
  • Appropriately monitor and closely observe all patients who are started on amitriptyline therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process. (See Worsening of Depression and Suicidality Risk under Cautions.)

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amitriptyline
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(a mee TRIP ti leen)

How should I take amitriptyline?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking amitriptyline. You may need to stop using the medicine for a short time.

Do not stop using amitriptyline without first talking to your doctor. You may need to use less and less before you stop the medication completely. Stopping this medication suddenly could cause you to have unpleasant side effects. It may take up to 4 weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment. Store amitriptyline at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of amitriptyline can be fatal.

Overdose symptoms may include uneven heartbeats, extreme drowsiness, confusion, agitation, vomiting, blurred vision, feeling hot or cold, sweating, muscle stiffness, feeling light-headed, fainting, seizure (convulsions), or coma.

What should I avoid while taking amitriptyline?

Avoid drinking alcohol. It can cause dangerous side effects when taken together with amitriptyline.

Grapefruit and grapefruit juice may interact with amitriptyline. Discuss the use of grapefruit products with your doctor before increasing or decreasing the amount of grapefruit products in your diet.

Amitriptyline can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Amitriptyline can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What are the possible side effects of amitriptyline?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:
  • fast, pounding, or uneven heart rate, chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

  • sudden numbness or weakness, especially on one side of the body;

  • sudden headache, confusion, problems with vision, speech, or balance;

  • hallucinations, or seizures (convulsions), feeling light-headed, fainting;

  • restless muscle movements in your eyes, tongue, jaw, or neck, uncontrollable shaking or tremor;

  • skin rash, severe tingling, numbness, pain, muscle weakness;

  • easy bruising or bleeding;

  • extreme thirst with headache, nausea, vomiting, and weakness; or

  • urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, vomiting, constipation, diarrhea, loss of appetite;

  • dry mouth, unpleasant taste;

  • feeling dizzy, drowsy, or tired;

  • trouble concentrating;

  • nightmares;

  • blurred vision, headache, ringing in your ears;

  • breast swelling (in men or women); or

  • decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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