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Drug Profile

Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.

Do Not Use [what does this mean?]
Generic drug name: trazodone (TRAZ oh done)
Brand name(s):
GENERIC: available FAMILY: Other Drugs for Depression
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

This drug caused harm to developing fetuses in animal studies, including death and birth defects. Use during pregnancy only for clear medical reasons. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take this drug.

Breast-feeding Warning

Trazodone is excreted in rat milk, suggesting that it is likely to be secreted in human milk. There is a risk of serious adverse effects to your infants if you nurse.

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING

Suicidality and Antidepressant Drugs

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening and for emergence of suicidal thoughts and behaviors. Trazodone hydrochloride tablets are not approved for use in pediatric patients.

Anticholinergic Effects

Warning: Special Mental and Physical Adverse Effects

Older adults are especially sensitive to the harmful anticholinergic effects of these drugs. Drugs in this family should not be used unless absolutely necessary.

Mental Effects: confusion, delirium, short-term memory problems, disorientation and impaired attention

Physical Effects: dry mouth, constipation, difficulty urinating (especially for a man with an enlarged prostate), blurred vision, decreased sweating with increased body temperature, sexual dysfunction and worsening of glaucoma

Facts About This Drug [top]

Trazodone (generic only) was approved by the FDA in 1981 for treatment of major depression. It is a selective serotonin reuptake inhibitor (SSRI). We have designated trazodone as Do Not Use because it has more harmful adverse effects (see Adverse Effects of Antidepressants tablesee Adverse Effects of Antidepressants table in Depression: When are Drugs Called For And Which Ones Should You Use?) than other newer SSRIs. For patients who need an antidepressant drug, we recommend trying one of the...

Trazodone (generic only) was approved by the FDA in 1981 for treatment of major depression. It is a selective serotonin reuptake inhibitor (SSRI). We have designated trazodone as Do Not Use because it has more harmful adverse effects (see Adverse Effects of Antidepressants tablesee Adverse Effects of Antidepressants table in Depression: When are Drugs Called For And Which Ones Should You Use?) than other newer SSRIs. For patients who need an antidepressant drug, we recommend trying one of the newer SSRIs (for example, fluoxetine [PROZAC, SARAFEM, SELFEMRA]) first, as these are the safest antidepressants. If symptoms do not improve sufficiently with use of an SSRI and remain severe, further treatment with other antidepressants is warranted. 

Patients over 60 generally need to take one-third to one-half the dose used by younger adults. If the initial dose is not enough and needs to be increased, this should be done very slowly.

 

The length of time it takes an antidepressant to work can overlap with the time of spontaneous recovery, especially if the depression is situational (if it is caused by a death or other external circumstances). Most people lift themselves out of depression with friends, spiritual resources, or activities such as exercise, work, reading, play, art, and travel. If depression is not overcome by these measures, seek help from mental health professionals, such as therapists or psychiatrists. Antidepressant drugs should be reserved for major depression in which the patient does not respond to psychotherapy alone.

 

Side effects

Trazodone can cause painful, prolonged penile erections (priapism) in men. If you suffer this reaction, stop taking the drug and notify your doctor.

Do not use trazodone if you are recovering from a heart attack.

Studies say…

A major meta-analysis commissioned by the U.S. Department of Health and Human Services failed to find any significant differences in effectiveness between older antidepressants (such as tricyclic antidepressants) and newer antidepressants (such as selective serotonin reuptake inhibitors, commonly known as SSRIs).

In terms of adverse drug reactions, there was no significant difference between the new and old antidepressants in overall discontinuation rates of use of these drugs by patients.[1] (Drug discontinuation rates can be used to compare adverse reactions between drugs.)

Regulatory actions surrounding trazodone

2004: In October 2004, the FDA issued a public health advisory requiring manufacturers to add a black box warning (see above) to its professional product labeling (package insert) of all antidepressants. A black box warning is the strongest type of warning that the FDA can require. The FDA also requires that a Patient Medication Guide be given to patients receiving this drug advising them of the risk and precautions that can be taken. 

2007: The FDA announced in May 2007 that it will require new warnings concerning the increased risk of suicidal thoughts and behavior in young adults ages 18 to 24 during the first one to two months of treatment with antidepressants. The agency wants the new warnings to be black box warnings printed on the professional product labels for all antidepressants sold in the US. The warning is an amendment to an existing black box warning for children and adolescents.[2]

The FDA-approved professional product labeling for antidepressant drugs sold in the United States carries the following statement:

Suicide: The possibility of a suicide attempt is inherent in major depressive disorder and may persist until significant remission occurs. Close supervision of high-risk patients should accompany initial drug therapy. Prescriptions for Drug X should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Before You Use This Drug [top]

Tell your doctor if you have or have had:

  •   allergies to drugs
  •   alcohol dependence
  •   kidney or liver problems
  •   retention of urine or enlarged prostate
  •   heart rhythm disturbance
  •   fever or sore throat
  •   pregnancy or are breast-feeding

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products. 

Ask your doctor to check your blood pressure, once while you are lying down and once after you have been standing up for at least two minutes, and to do an electrocardiogram.

When You Use This Drug [top]

  • Do not stop taking this drug suddenly. Your doctor must give you a schedule to lower your dose gradually, to prevent withdrawal symptoms such as headache, mood change, nausea, vomiting, diarrhea, and trouble sleeping and vivid dreams.
  • Until you know how you react to this drug, do not drive or perform other activities requiring alertness. This drug may cause blurred vision and drowsiness.
  • It may take several weeks before you can tell that this drug is working. If the drug works, talk with your doctor about gradually lowering the dose.
  • Do not smoke. Smoking may increase the drug’s effects on your heart.
  • Do not drink alcohol or use other drugs that can cause drowsiness.
  • You may feel dizzy when rising from a lying or sitting position. When getting out of bed, hang your legs over the side of the bed for a few minutes, then get up slowly. When getting up from a chair, stay beside the chair until you are sure that you are not dizzy.
  • Check with your doctor before taking any other drugs, prescription or nonprescription. This drug frequently interacts with other drugs.
  • The effects of this drug may last for up to a week after you stop taking it. Avoid alcohol and heed all other warnings for this time period.
  • If you plan to have any surgery, including dental, tell your doctor that you take this drug.
  • Check with your doctor if dry mouth continues for more than two weeks.

How to Use This Drug [top]

  • If you miss a dose, take it as soon as you remember, but skip it if it is less than four hours until your next scheduled dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Take with food.
  • If you are taking any other drugs, take them one to two hours before you take your antidepressant.
  • Use sugarless gum, ice, or saliva substitute if you develop a dry mouth.
  • Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.

Interactions with Other Drugs [top]

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

Central nervous system (CNS) depressant drugs, including alcohol, antidepressants, antihistamines, antipsychotics, some blood pressure medications (reserpine, methyldopa, beta-blockers), motion sickness medications, muscle relaxants, narcotics, sedatives, sleeping pills, and tranquilizers.

Other interacting drugs are: digoxin, LANOXIN, ritonavir (NORVIR).

Adverse Effects [top]

Call your doctor immediately if you experience:

  •   painful, inappropriate erection of the penis
  •   muscle tremors
  •   fainting
  •   skin rash
  •   unusual excitement

Call your doctor if these symptoms continue:

  •   dizziness
  •   dry mouth
  •   headache
  •   unpleasant taste in mouth
  •   blurred vision
  •   constipation
  •   nausea and vomiting
  •   diarrhea
  •   muscle aches or pains
  •   unusual tiredness or weakness

Signs of overdose:

  •   confusion
  •   severe drowsiness
  •   fever
  •   hallucinations
  •   restlessness and agitation
  •   seizures
  •   shortness of breath
  •   trouble breathing
  •   irregular heartbeat
  •   unusual tiredness
  •   weakness
  •   nausea and vomiting

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  •   complete blood count
  •   blood pressure
  •   heart function tests, such as electrocardiogram (ECG, EKG)
  •   leukocyte and neutrophil counts

last reviewed January 31, 2021