Trazodone is a tetracyclic antidepressant medication. It is thought to increase the activity of one of the brain chemicals (serotonin) which may become unbalanced and cause depression. It may also be used for relief of anxiety disorders (eg, sleeplessness, tension) and chronic pain.

Trazodone is used to treat depression.

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

Important information about Trazodone

Before taking trazodone, tell your doctor if you are allergic to any drugs, or if you have bipolar disorder (manic depression), schizophrenia or other psychiatric illness, a history of drug abuse or suicidal thoughts, or if you have recently had a heart attack.

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.

Trazodone works best if you take it after a meal or a snack. 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. Trazodone 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. Do not drink alcohol while you are taking trazodone. Alcohol can increase drowsiness and dizziness caused by trazodone. Stop taking trazodone and call your doctor at once if you have a penis erection that is painful or lasts 4 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery.

Before taking Trazodone

Do not use this medication if you are allergic to trazodone.

Before using trazodone, tell your doctor if you are allergic to any drugs, or if you have:

• bipolar disorder (manic depression);
• schizophrenia, or other psychiatric illness;
• a history of drug abuse or suicidal thoughts; or
• if you have recently had a heart attack.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take trazodone.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of 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. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Trazodone may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give trazodone to anyone younger than 18 years old without the advice of a doctor.

How should I take Trazodone?

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.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Trazodone works best if you take it after a meal or a snack.

You may need to take this medicine at bedtime, because trazodone can cause drowsiness. Follow your doctor’s instructions.

If you need to have any type of surgery, tell the surgeon ahead of time that you are using trazodone. You may need to stop using the medicine for a short time. It may take up to 2 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 2 weeks of treatment. You may need to take trazodone for several weeks or months to control your depression symptoms.

To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Store trazodone 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your 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 trazodone can be fatal when it is taken with alcohol, barbiturates such as phenobarbital, or sedatives such as diazepam (Valium).

Overdose symptoms may include drowsiness, vomiting, penis erection that is painful or prolonged, uneven heart rate, seizure (black-out or convulsions), or breathing that slows or stops.

Trazodone side effects

Stop taking trazodone and call your doctor at once if you have a penis erection that is painful or lasts 4 hours or longer. This is a medical emergency and could lead to a serious condition that must be corrected with surgery. 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:

• feeling light-headed, fainting;
• fever, chills, body aches, flu symptoms; or
• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or
• problems with urination.

Less serious trazodone side effects may be more likely to occur, such as:

• dizziness or drowsiness;
• headache;
• sleep problems (insomnia);
• dry mouth, stuffy nose;
• nausea, vomiting, loss of appetite;
• diarrhea or constipation;
• muscle pain;
• loss of coordination; or
• blurred vision.

This is not a complete list of trazodone side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Trazodone?

Before taking trazodone, tell your doctor if you are using any of the following drugs:

• an HIV medicine such as indinavir (Crixivan) or ritonavir (Norvir);
• an antibiotic such as ketoconazole (Nizoral) or itraconazole (Sporanox);
• digoxin (Lanoxin, Lanoxicaps);
• seizure medicine such as carbamazepine (Carbatrol, Tegretol) or phenytoin (Dilantin);
• warfarin (Coumadin); or
• if you have taken an MAO inhibitor within the past 14 days, such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

This list is not complete and there may be other drugs that can interact with trazodone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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Haloperidol is an antipsychotic medication. It works by changing the actions of chemicals in your brain.

Haloperidol is used to treat schizophrenia. It is also used to control motor and speech tics in people with Tourette’s syndrome.

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

What is the most important information I should know about Haldol (Haloperidol)?

Haloperidol is not for use in psychotic conditions related to dementia. Haloperidol may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Haloperidol 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 getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. It can increase drowsiness or dizziness caused by haloperidol.

What should I discuss with my healthcare provider before taking Haldol (Haloperidol)?

Haloperidol is not for use in psychotic conditions related to dementia. Haloperidol may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. You should not use this medication if you are allergic to haloperidol, or have certain conditions. Be sure your doctor knows if you have Parkinson’s disease.

Before taking haloperidol, tell your doctor if you are allergic to any drugs, or if you have:

• liver disease;
• kidney disease;
• heart disease, angina (chest pain);
• a thyroid disorder;
• epilepsy or other seizure disorder;
• a personal or family history of “Long QT syndrome”;
• an electrolyte imbalance such as low potassium or magnesium levels in your blood.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take haloperidol.

It is not known whether haloperidol is harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Haloperidol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take Haldol (Haloperidol)?

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

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Taking too much of this medication can cause a serious heart rhythm disorder or sudden death. Never take more than your prescribed dose. Take haloperidol with a full glass of water.

Haloperidol can be taken with or without food.

It may take several weeks of using this medicine before your symptoms improve. For best results, keep using the medication as directed. Do not stop using haloperidol suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication. Store haloperidol 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, wait until then to take the medicine and skip the missed dose. 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 haloperidol can be fatal.

Overdose symptoms may include extreme drowsiness, feeling like you might pass out, tremors, and uncontrolled muscle movements in your eyes, tongue, jaw, or neck.

Haldol (Haloperidol) side effects

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 of these serious side effects:

• dizziness, fainting, fast or pounding heartbeat;
• restless muscle movements in your eyes, tongue, jaw, or neck;
• tremor (uncontrolled shaking);
• fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
• stabbing chest pain, feeling short of breath, cough with yellow or green mucus;
• sudden mood changes;
• confusion, agitation, hallucinations, unusual thoughts or behavior; or
• jaundice (yellowing of your skin or eyes).

Less serious side effects may include:

• headache, dizziness, drowsiness;
• sleep problems (insomnia);
• feeling restless or anxious;
• mild skin rash or itching;
• breast enlargement, irregular menstrual periods, loss of interest in sex; or
• dry mouth, blurred vision, urinating less than usual.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Haldol (Haloperidol) Dosing Information

Usual Adult Dose for ICU Agitation:

Haloperidol lactate:
IV, intermittent: 0.03 to 0.15 mg/kg IV (2 to 10 mg) every 30 minutes to 6 hours.
IV, infusion: 3 to 25 mg/hour by continuous IV infusion, has been used for ventilator patients with agitation and delirium.

Usual Adult Dose for Dementia:

For non-psychotic behavioral problems related to dementia:
Initial dose: 0.5 mg orally 2 to 3 times daily.
Maintenance dose: 0.5 to 3 mg orally 2 times a day.

Usual Adult Dose for Mania:

Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day
Maintenance dose: 1 to 30 mg/day in 2 or 3 divided doses. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

Parenteral:
Haloperidol Lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.

Usual Adult Dose for Nausea/Vomiting:

Oral:
1 to 5 mg orally every 4 to 6 hours as needed.

Parenteral:
Haloperidol lactate:
1 to 5 mg IM or IV every 4 to 6 hours as needed.

Usual Adult Dose for Psychosis:

Oral:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

Parenteral:
Haloperidol lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.

Haloperidol decanoate:
Initial dose: 10 to 15 times the previous oral daily dose intramuscularly every 3 to 4 weeks. The initial dose should not exceed 100 mg and the balance should be given in 3 to 7 days. There is limited experience with doses greater than 450 mg/month. Do not give IV.

Usual Adult Dose for Tourette’s Syndrome:

Initial dose: 0.5 to 2 mg orally 2 to 3 times a day.
Maintenance dose: May increase every 5 to 7 days to 3 to 5 mg 2 to 3 times daily for more severe or resistant cases.

Usual Geriatric Dose for not applicable:

Delirium: 0.25 to 0.5 mg orally or IM every 4 hours.

Usual Geriatric Dose for Psychosis:

Oral:
Initial dose: 0.5 to 2 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses. The lowest possible effective dose should be used since geriatric patients are more sensitive to the adverse effects of haloperidol (e.g., tardive dyskinesia).

Parenteral:
Haloperidol Lactate:
2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.

Usual Pediatric Dose for Psychosis:

Oral:
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Initial dose: 0.5 mg/day orally in 2 to 3 divided doses.
Maintenance dose: The daily dose may be increased every 5 to 7 days in 0.25 to 0.5 mg increments. The usual range is 0.05 to 0.15 mg/kg/day in 2 to 3 divided doses. There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
13 to 18 years and greater than 40 kg:
Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.
Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

Parenteral:
Haloperidol lactate:
5 years younger: Use is not recommended.
6 to 12 years: 1 to 3 mg IM every 4 to 8 hours as needed (maximum 0.15 mg/kg/day). Patients should be switched to oral therapy as soon as possible.
13 to 18 years: 2 to 5 mg IM every 4 to 8 hours as needed.

Haloperidol decanoate:
17 year or younger: Safety and efficacy have not been established.

Usual Pediatric Dose for Tourette’s Syndrome:

2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Initial dose: 0.5 mg/day orally in 2 to 3 divided doses.
Maintenance dose: The daily dose may be increased weekly in 0.25 to 0.5 mg increments up to 0.05 to 0.075 mg/kg/day. There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
13 to 18 years and greater than 40 kg: 1 to 2 mg orally 2 to 3 times a day.

Usual Pediatric Dose for not applicable:

Oral:
2 years or younger or less than 15 kg: Use is not recommended.
3 to 12 years and 15 to 40 kg:
Agitation/Hyperkinesia: 0.01 to 0.03 mg/kg/day, up to a maximum of 0.15 mg/kg/day.
Autism: 0.5 to 4 mg/day.
13 to 18 years and greater than 40 kg: 0.5 to 5 mg orally 2 to 3 times a day.

Intramuscular:
Haloperidol lactate:
5 years or younger: Use is not recommended.
6 to 12 years: 1 to 3 mg IM every 4 to 8 hours as needed (maximum 0.15 mg/kg/day). Patients should be switched to oral therapy as soon as possible.
13 to 18 years: 2 to 5 mg IM every 4 to 8 hours as needed.

What other drugs will affect Haldol (Haloperidol)?

Before using haloperidol, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by haloperidol.

The following drugs can interact with haloperidol. Tell your doctor if you are using any of these:

• lithium (Eskalith, Lithobid, others);
• a blood thinner such as warfarin (Coumadin); or
• rifampin (Rifadin, Rifamate, Rimactane).

This list is not complete and there may be other drugs that can interact with haloperidol. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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