Desyrel

(Generic versions may still be available.)

DRUG DESCRIPTION

DESYREL (trazodone hydrochloride) is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4- triazolo[4,3-a]pyridin-3(2H)-one hydrochloride. It is a white, odorless, crystalline powder which is freely soluble in water. Its molecular weight is 408.3. The empirical formula is C19H22ClN5O•HCl and the structural formula is represented as follows:

DESYREL® (trazodone HCl) Structural Formula Illustration

DESYREL (trazodone hydrochloride) is supplied for oral administration in 50 mg, 100 mg, 150 mg, and 300 mg tablets.

DESYREL (trazodone hydrochloride) Tablets, 150 mg, contain the following inactive ingredients: microcrystalline cellulose, FD&C Yellow No. 6 (aluminum lake), magnesium stearate, pregelatinized starch, and stearic acid.

DESYREL (trazodone hydrochloride) Tablets, 300 mg, contain the following inactive ingredients: microcrystalline cellulose, yellow ferric oxide, magnesium stearate, sodium starch glycolate, pregelatinized starch, and stearic acid.

What are the possible side effects of trazodone (Desyrel)?

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...

Read All Potential Side Effects and See Pictures of Desyrel »

What are the precautions when taking trazodone hydrochloride (Desyrel)?

Before taking trazodone, tell your doctor or pharmacist if you are allergic to it; or to nefazodone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of priapism from taking trazodone, recent heart attack.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of bipolar disorder, personal or family history of suicide attempts, heart disease (e.g., irregular heartbeat), liver disease, kidney disease, blood pressure...

Read All Potential Precautions of Desyrel »


Desyrel Consumer (continued)

SIDE EFFECTS: See also the Warning section.

Nausea, vomiting, diarrhea, drowsiness, dizziness, tiredness, blurred vision, changes in weight, headache, muscle ache/pain, dry mouth, bad taste in the mouth, stuffy nose, constipation, or change in sexual interest/ability may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: shaking (tremors), nightmares, ringing in the ears, problems urinating, blood in urine.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), shortness of breath, stomach/abdominal pain.

Get medical help right away if any of these rare but serious side effects occur: chest/jaw/left arm pain, fainting, fast/irregular heartbeat, seizures, severe dizziness.

For males, in the very unlikely event you have a painful or prolonged erection (priapism) lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking trazodone, tell your doctor or pharmacist if you are allergic to it; or to nefazodone; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: history of priapism from taking trazodone, recent heart attack.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of bipolar disorder, personal or family history of suicide attempts, heart disease (e.g., irregular heartbeat), liver disease, kidney disease, blood pressure problems.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Trazodone may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using trazodone, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using trazodone safely.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially drowsiness and dizziness.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk. Consult your doctor before breast-feeding.


Desyrel Patient Information Including Side Effects

Brand Names: Desyrel

Generic Name: trazodone (Pronunciation: TRAZ oh done)

  • What is trazodone (Desyrel)?
  • What are the possible side effects of trazodone (Desyrel)?
  • What is the most important information I should know about trazodone (Desyrel)?
  • What should I discuss with my healthcare provider before taking trazodone (Desyrel)?
  • How should I take trazodone (Desyrel)?
  • What happens if I miss a dose (Desyrel)?
  • What happens if I overdose (Desyrel)?
  • What should I avoid while taking trazodone (Desyrel)?
  • What other drugs will affect trazodone (Desyrel)?
  • Where can I get more information?

What is trazodone (Desyrel)?

Trazodone is an antidepressant medication. It affects chemicals in the brain that may become unbalanced and cause depression

Trazodone is used to treat depression.

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

What are the possible side effects of trazodone (Desyrel)?

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 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 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 is the most important information I should know about trazodone (Desyrel)?

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.

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