Silenor Side Effects

Generic Name: doxepin

Note: This document contains side effect information about doxepin. Some of the dosage forms listed on this page may not apply to the brand name Silenor.

Some side effects of Silenor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to doxepin: oral capsule, oral solution, oral tablet

Along with its needed effects, doxepin (the active ingredient contained in Silenor) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking doxepin:

Incidence not known
  • Abdominal or stomach pain
  • agitation
  • black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • canker sores
  • chest pain
  • chills
  • clay-colored stools
  • cold sweats
  • confusion about identity, place, and time
  • convulsions
  • cool, pale skin
  • cough or hoarseness
  • dark urine
  • decrease in the frequency of urination
  • decrease in urine volume
  • decreased urine output
  • depression
  • difficulty in passing urine (dribbling)
  • difficulty with breathing
  • difficulty with speaking
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drooling
  • dry mouth
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of warmth
  • fever
  • flushed, dry skin
  • fruit-like breath odor
  • general feeling of tiredness or weakness
  • headache
  • hearing loss
  • hostility
  • increased hunger
  • increased thirst
  • increased urination
  • irritability
  • itching
  • lethargy
  • lip smacking or puckering
  • loss of appetite
  • loss of balance control
  • loss of bladder control
  • lower back or side pain
  • mood or mental changes
  • muscle spasm or jerking of all extremities
  • muscle trembling, jerking, or stiffness
  • muscle twitching
  • nausea
  • nervousness
  • nightmares
  • noisy breathing
  • painful or difficult urination
  • pinpoint red spots on the skin
  • pounding in the ears
  • puffing of the cheeks
  • rapid or worm-like movements of the tongue
  • rapid weight gain
  • rash
  • redness of the face, neck, arms, and occasionally, upper chest
  • restlessness
  • ringing or buzzing or other unexplained noise in the ears that continues
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shakiness and unsteady walk
  • shakiness in the legs, arms, hands, or feet
  • shortness of breath
  • shuffling walk
  • sore throat
  • sores, ulcers, or white spots on the lips, tongue, or in the mouth
  • slurred speech
  • stiffness of the limbs
  • stupor
  • sudden loss of consciousness
  • sweating
  • swelling of the face, ankles, or hands
  • swollen glands
  • tightness in the chest
  • troubled breathing
  • twisting movements of the body
  • uncontrolled chewing movements
  • uncontrolled movements, especially of the arms, face, legs, neck, and back
  • unexplained weight loss
  • unpleasant breath odor
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood
  • wheezing
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking doxepin:

Symptoms of overdose
  • Clumsiness
  • disturbed concentration
  • drowsiness
  • enlarged pupils
  • increased or excessive unconscious or jerking movements
  • low body temperature
  • muscle aches
  • muscle weakness
  • shivering
  • sleepiness
  • weak or feeble pulse
  • weight gain

Some side effects of doxepin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Change in taste or bad, unusual or unpleasant (after)taste
  • decreased interest in sexual intercourse
  • diarrhea
  • difficulty having a bowel movement (stool)
  • enlargement of the breasts
  • gas in stomach
  • hair loss or thinning of the hair
  • heartburn
  • inability to have or keep an erection
  • increased in sexual ability, desire, drive, or performance
  • increased interest in sexual intercourse
  • increased sensitivity of the skin to sunlight
  • loss in sexual ability, desire, drive, or performance
  • redness or other discoloration of the skin
  • severe sunburn
  • swelling of the breasts or breast soreness in both females and males
  • swelling of the testicles
  • unexpected or excess milk flow from breasts
  • weight loss

For Healthcare Professionals

Applies to doxepin: oral capsule, oral concentrate, oral tablet

Nervous system

Nervous system side effects have been reported more frequently with drowsiness as the most cited adverse effect. Dystonia, myoclonus, worsening of seizure control, hoarseness, aphonia, visual hallucinations, and tinnitus have also been reported. Mania can occur and is a particular risk in patients with bipolar disease.

Other

Anticholinergic side effects have been reported frequently and include blurry vision, dry mouth, constipation and urinary retention.

Although doxepin is not addicting, withdrawal symptoms after abrupt discontinuation may occur and include hypertension, tachycardia, restlessness, abdominal distress and emesis. A case of doxepin withdrawal mania has also been reported.

Gastrointestinal

Gastrointestinal side effects have included constipation and dry mouth and less frequently nausea and vomiting.

A study of 26,005 antidepressant users has reported 2.3 times more upper GI bleeding episodes with the use of non-SSRI's. Upper gastrointestinal tract bleeding was observed in 2.0 times more frequently in patients receiving doxepin.

Cardiovascular

The incidence of orthostatic hypotension is thought to be higher with doxepin (the active ingredient contained in Silenor) than with other tricyclic antidepressants. Both antiarrhythmic and proarrhythmic effects have been reported in association with doxepin therapy, however, the incidence of proarrhythmic effects may be lower with doxepin than other tricyclic antidepressants. Caution, however, should be exercised if doxepin must be used in patients with cardiovascular disease.

Cardiovascular side effects have included orthostatic hypotension, tachycardia, syncope, intracardiac conduction blocks, and ventricular arrhythmias. Torsades de pointes tachycardia has been reported in a woman who swallowed 6 g of doxepin in an attempt to commit suicide.

Endocrine

A retrospective register study of the World Health Organization (WHO) database for spontaneous reporting of adverse drug reactions (n=668) suggests that the risk of hyponatremia during treatment with antidepressants seems to be highest in women, in the elderly, during the summer season, and during the first weeks of therapy.

Endocrine side effects have included hyperprolactinemia and hyponatremia (in association with the syndrome of inappropriate secretion of antidiuretic hormone).

Oncologic

Oncologic side effects have included a case of breast cancer occurring in a male taking doxepin (the active ingredient contained in Silenor)

Hematologic

Hematologic side effects have included immune hemolytic anemia and thrombocytopenia.

General

General side effects commonly reported have included weight gain. Anorexia has also been reported.

Hepatic

Hepatic side effects have included induction of cholestatic and hepatic reactions generally related to idiosyncratic hypersensitivity associated with the use of tricyclic antidepressants. Although these have generally been mild, severe injuries with fulminant hepatitis have been reported. A single case report has suggested that doxepin (the active ingredient contained in Silenor) may induce recurrent acute hepatitis.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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