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:
amoxapine
(a MOX a peen)
Brand name(s):
GENERIC:
available
FAMILY:
Tricyclics
Find the drug label by
searching at DailyMed.
Do Not Use
[what does this mean?]
Generic drug name:
doxepin
(DOX e pin)
Brand name(s):
SILENOR,
SINEQUAN
GENERIC:
available
FAMILY:
Tricyclics
Find the drug label by
searching at DailyMed.
Do Not Use
[what does this mean?]
Generic drug name:
imipramine
(im IP ra meen)
Brand name(s):
TOFRANIL,
TOFRANIL PM
GENERIC:
available
FAMILY:
Tricyclics
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
There have been clinical reports of congenital malformations associated with the use of imipramine. Do not use during pregnancy. Amoxapine and doxepin have not been adequately tested but can be assumed to pose similar risks.
Breast-feeding Warning
Data suggest that imipramine is excreted in milk. There is a report of trouble breathing and drowsiness in a nursing infant whose mother is taking doxepin, another drug in this group. Because the possibility exists that the drugs can harm the child, mothers taking these drugs should not nurse.
Safety Warnings For This Drug [top]
FDA BLACK BOX WARNING
Suicidality and Antidepressant Drugs
Compared with placebo, antidepressants increased the risk of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder and other psychiatric disorders. Anyone considering the use of amoxapine (generic only), doxepin, imipramine or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared with placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
Amoxapine, doxepin and imipramine 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]
The drugs discussed in this profile are known as tricyclic antidepressants. They are used to treat severe depression that is not caused by other drugs, alcohol or emotional losses (such as a death in the family). We have designated amoxapine, doxepin (SILENOR) and imipramine (TOFRANIL) as Do Not Use because they have more harmful adverse effects (see Adverse Effects of Antidepressants table in Depression: When are Drugs Called For And Which Ones Should You Use?) than the newer SSRIs and...
The drugs discussed in this profile are known as tricyclic antidepressants. They are used to treat severe depression that is not caused by other drugs, alcohol or emotional losses (such as a death in the family). We have designated amoxapine, doxepin (SILENOR) and imipramine (TOFRANIL) as Do Not Use because they have more harmful adverse effects (see Adverse Effects of Antidepressants table in Depression: When are Drugs Called For And Which Ones Should You Use?) than the newer SSRIs and certain other tricyclic antidepressants. For patients who need an antidepressant drug, we recommend trying one of the newer selective serotonin reuptake inhibitors (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.
| Don’t overdose Patients over 60 generally need to take one-third to one-half the dose of antidepressants -used by younger adults. If the initial dose is not enough and needs to be increased, this should be done very slowly. |
Amoxapine can cause tardive dyskinesia—uncontrolled movements of the jaws, tongue, and lips—a side effect also seen with antipsychotic drugs. Doxepin (SINEQUAN) has especially strong sedative effects.
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.
Studies say…
A major meta-analysis commissioned by the U.S. Department of Health and Human Services failed to show any significant difference in effectiveness between tricyclic antidepressants and selective serotonin reuptake inhibitors (SSRIs), a newer class of antidepressants.
The side effects of new and old antidepressants are different—except for withdrawal symptoms, which are common to both tricyclic antidepressants and SSRIs. But patients are simply trading off one group of side effects for another when deciding between the two types of antidepressants.
There does not appear to be any difference in the proportion of people who can tolerate either of these two groups of antidepressants. In terms of side effects, large-scale meta-analyses found no significant difference between the SSRIs and tricyclic 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.)
In 2015, a study published in JAMA Internal Medicine showed that strong anticholinergic drugs were associated with an increased risk of dementia in older adults. The study also showed that higher doses and longer use of these drugs are associated with higher risk of dementia.[2]
Refer to the August 2015 issue of Worst Pills, Best Pills News for examples of strong anticholinergic drugs.
Regulatory actions surrounding tricyclic antidepressants
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.
2007: The FDA announced in May 2007 that it would 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 black-box warnings are printed on the professional product labels for all antidepressants sold in the U.S. The warning is an amendment to an existing black-box warning for children and adolescents.[3]
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:
The depressant effects of alcohol, barbiturates, and central nervous system (CNS) depressants may be enhanced with the use of these drugs.
ADRENALIN (also in bee sting kits), arbutamine, CELEXA, cimetidine, citalopram, COMTAN, CYTOMEL, entacapone, epinephrine, flecainide, fluoxetine, guanethidine, IMDUR, ISMELIN, ISMO, ISORDIL, isosorbide, liothyronine, MELLARIL, MERIDIA, nitroglycerin (sublingual), NITROBID, NITRO-DUR, NITROSTAT, NORVIR, paroxetine, PAXIL, PRIMATENE MIST, propafenone, PROZAC, quinidine, ritonavir, RYTHMOL, sertraline, sibutramine, SORBITRATE, TAGAMET, TAMBOCOR, thioridazine, tolazamide, TOLINASE, tramadol, TRANSDERM-NITRO, TRIOSTAT, ULTRACET, ULTRAM, ZOLOFT.
You should wait at least 14 days after stopping one of these drugs and starting one of these MAO inhibitors: deprenyl, ELDEPRYL, furazolidone, FUROXONE, isocarboxazid, MARPLAN, MATULANE, NARDIL, PARNATE, phenelzine, procarbazine, selegiline, tranylcypromine.
Adverse Effects [top]
Call your doctor immediately if you experience:
For tricyclic antidepressants:
Call your doctor if these symptoms continue:
For amoxapine only (in addition to above):
Signs of neuroleptic malignant syndrome:
Call your doctor if these symptoms continue after you stop taking the drug:
For amoxapine only (in addition to above):
Signs of tardive dyskinesia:
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 July 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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