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:
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]
How to Use This Drug [top]
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:
Call your doctor if these symptoms continue:
Signs of overdose:
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:
last reviewed January 31, 2024
Worst Pills, Best Pills is a project of Public Citizen's Health Research Group Group. As an independent, nonprofit organization, we take no corporate or government contributions and accept no advertising. Copyright © 2024 Public Citizen's Health Research Group. All rights reserved.
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