What is the most important information I should know about amitriptyline?

Do not use this medication if you are allergic to amitriptyline, or if you have recently had a heart attack.

Do not use amitriptyline if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) within the past 14 days.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Report any new or worsening symptoms to your doctor, 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.

What is amitriptyline?

Amitriptyline is a tricyclic antidepressant. Amitriptyline affects chemicals in the brain that may become unbalanced.

Amitriptyline is used to treat symptoms of depression.

Amitriptyline may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking amitriptyline?

You should not use this medication if you are allergic to amitriptyline, or if you have recently had a heart attack.

Do not use amitriptyline if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate) in the last 14 days. A dangerous drug interaction could occur, leading to serious side effects.

To make sure you can safely take amitriptyline, tell your doctor if you have any of these other conditions:

• heart disease;
• a history of heart attack, stroke, or seizures;
• bipolar disorder (manic-depression);
• schizophrenia or other mental illness;
• diabetes (amitriptyline may raise or lower blood sugar);
• overactive thyroid;
• glaucoma; or
• problems with urination.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. It is not known whether amitriptyline will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Amitriptyline can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using amitriptyline.

Do not give this medication to anyone under 12 years old without medical advice.

How should I take amitriptyline?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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

Do not stop using amitriptyline suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using amitriptyline.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of amitriptyline can be fatal.

Overdose symptoms may include uneven heartbeats, extreme drowsiness, confusion, agitation, vomiting, hallucinations, feeling hot or cold, muscle stiffness, seizure (convulsions), or fainting.

What should I avoid while taking amitriptyline?

Do not drink alcohol. It can cause dangerous side effects when taken together with amitriptyline.

This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid exposure to sunlight or tanning beds. Amitriptyline can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

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.

Report any new or worsening symptoms to your doctor, 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 a serious side effect such as:

• 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 severe headache, confusion, problems with vision, speech, or balance;
• pounding heartbeats or fluttering in your chest;
• feeling like you might pass out;
• confusion, hallucinations, seizures (convulsions);
• restless muscle movements in your eyes, tongue, jaw, or neck, uncontrollable shaking or tremor;
• extreme thirst with headache, nausea, vomiting, and weakness;
• numbness, burning pain, or tingly feeling;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
• 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect amitriptyline?

Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety can add to sleepiness caused by amitriptyline. Tell your doctor if you regularly use any of these medicines, or any other antidepressants.

Before taking amitriptyline, tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft).

Tell your doctor about all other medicines you use, especially:

• cimetidine (Tagamet);
• isoniazid (for treating tuberculosis);
• methimazole (Tapazole);
• nicardipine (Cardene);
• ropinirole (Requip);
• ticlopidine (Ticlid);
• an antibiotic such as terbinafine (Lamisil);
• anti-malaria medication such as chloroquine (Arelan) or pyrimethamine (Daraprim), or quinine (Qualaquin);
• HIV or AIDS medicine such as delavirdine (Rescriptor) or ritonavir (Norvir, Kaletra);
• medicine to treat psychiatric disorders, such as aripiprazole (Abilify), chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), perphenazine (Trilafon), or thioridazine (Mellaril);
• a heart rhythm medication such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), ibutilide (Corvert), or sotalol (Betapace); or
• a heart rhythm medication such as disopyramide (Norpace), dronedarone (Multaq), flecainide (Tambocor), mexiletine (Mexitil), procainamide (Pronestyl), propafenone (Rythmol), or quinidine (Quin-G).

This list is not complete and there are many other drugs that can interact with amitriptyline. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about amitriptyline.