Tofranil is a tricyclic antidepressant used to treat symptoms of depression. This medicine is sometimes used to treat bed-wetting in children ages 6 and older.

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

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Tell your doctor if you have a planned surgery.

Call your doctor if your symptoms do not improve, or if they get worse.

You should not stop using Tofranil suddenly. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

You should not use Tofranil if you are allergic to it, or if:

• you recently had a heart attack; or

• you are allergic to other antidepressants (amitriptyline, amoxapine, clomipramine, desipramine, doxepin, nortriptyline, protriptyline, or trTofranil).

Do not use Tofranil if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Tell your doctor if you have used an "SSRI" antidepressant in the past 5 weeks, such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone.

Tell your doctor if you have ever had:

• heart disease, stroke, or seizures;

• bipolar disorder (manic-depression), schizophrenia or other mental illness;

• kidney or liver disease;

• overactive thyroid;

• narrow-angle glaucoma; or

• problems with urination.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

It is not known whether Tofranil will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

You should not breastfeed while using Tofranil.

Do not give this medicine to a child without medical advice. Tofranil is not approved to treat depression in anyone younger than 18 years old. This medicine should not be used to treat bed-wetting in a child younger than 6 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Overdose symptoms may include irregular heartbeats, feeling like you might pass out, seizures, or coma.

Do not drink alcohol. Dangerous side effects or death can occur when alcohol is combined with Tofranil.

Avoid driving or hazardous activity until you know how Tofranil will affect you. Your reactions could be impaired.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult 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.

Tofranil may cause serious side effects. Call your doctor at once if you have:

• easy bruising, unusual bleeding, purple or red spots under your skin;

• tunnel vision, eye pain or swelling, or seeing halos around lights;

• a light-headed feeling, like you might pass out;

• new or worsening chest pain, pounding heartbeats or fluttering in your chest;

• sudden numbness or weakness, problems with vision, speech, or balance;

• fever, sore throat;

• confusion, hallucinations, unusual thoughts or behavior;

• painful or difficult urination;

• seizure (convulsions); or

• jaundice (yellowing of the skin or eyes).

Common side effects of Tofranil may include:

• increased blood pressure;

• tingly feeling, weakness, lack of coordination;

• dry mouth, nausea, vomiting; or

• breast swelling (in men or women).

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.

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking Tofranil with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Many drugs can affect Tofranil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.