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

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

Serious side effects of Silenor

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

• 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 or tightness
• chills
• clay-colored stools
• cold sweats
• confusion about identity, place, and time
• 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 or rash
• 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
• 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
• shuffling walk
• sore throat
• sores, ulcers, or white spots on the lips, tongue, or in the mouth
• slurred speech
• stiffness of the limbs
• stomach pain
• stupor
• sudden loss of consciousness
• sweating
• swelling of the face, ankles, or hands
• swollen glands
• trouble 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
• 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

Other side effects of Silenor

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 the 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.

General

Capsules and Oral Concentrate: The most frequently reported side effects were constipation, dry mouth, and drowsiness.

Tablets (3 and 6 mg): The most frequently reported side effects were somnolence/sedation, nausea, and upper respiratory tract infection.^[Ref]

Nervous system

Common (1% to 10%): Somnolence/sedation

Frequency not reported: Drowsiness, numbness, paresthesia, ataxia, extrapyramidal symptoms, seizure, tardive dyskinesia, tremor, dizziness, headache, neuroleptic malignant-like syndrome, convulsion, hyperreflexia in neonate, lethargy, syncope, ageusia, cerebrovascular accident, disturbance in attention, migraine, sleep paralysis, syncope vasovagal

Postmarketing reports: Hypoesthesia, dysgeusia^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Frequency not reported: Hypotension, flushing, tachycardia, ECG changed, postural hypotension, atrioventricular block, palpitation, ventricular extrasystole, ECG ST-T segment abnormal, ECG QRS complex abnormal, heart rate decreased, QRS axis abnormal, pallor, blood pressure inadequately controlled, hematoma, hot flush

Postmarketing reports: Arrhythmia, conduction disorder^[Ref]

Gastrointestinal

Common (1% to 10%): Gastroenteritis, nausea

Frequency not reported: Dry mouth, constipation, vomiting, indigestion, taste disturbance, diarrhea, anorexia, aphthous stomatitis, abdominal pain, gastroesophageal reflux disease, dyspepsia, gingival recession, hematochezia, lip blister

Postmarketing reports: Tongue edema, upper abdominal pain^[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection/nasopharyngitis

Frequency not reported: Asthma exacerbated, respiratory depression in neonate, bronchitis, laryngitis, sinusitis, lower respiratory tract infection, pharyngitis, pneumonia, nasal congestion, pharyngolaryngeal pain, sinus congestion, wheezing, cough, crackles lung, nasopharyngeal disorder, rhinorrhea, dyspnea^[Ref]

Psychiatric

Frequency not reported: Confusion, disorientation, hallucination, libido decreased, libido increased, withdrawal symptom, agitation, anxiety, nervousness, aggressive reaction, suicidal ideation, suicidal behavior, insomnia, nightmare, mania exacerbated, paranoid delusions exacerbated, dream abnormal, adjustment disorder, depression, elevated mood^[Ref]

Other

Frequency not reported: Edema, tinnitus, weight gain, chills, fatigue, weakness, hyperpyrexia, asthenia, bone fracture, drug tolerance, ear pain, hypoacusis, motion sickness, tympanic membrane perforated, chest pain, gait abnormal, peripheral edema, fungal infection, tooth infection, viral infection, cellulitis staphylococcal, folliculitis, gastroenteritis viral, herpes zoster, infective tenosynovitis, influenza, onychomycosis, back injury, fall, joint sprain, skin laceration, sensation of heaviness, arthrodesis

Postmarketing reports: Malaise^[Ref]

Endocrine

Frequency not reported: Gynecomastia, breasts enlarged, galactorrhea, testicular swelling, syndrome of inappropriate antidiuretic hormone^[Ref]

Oncologic

Frequency not reported: Lung adenocarcinoma stage I, malignant melanoma, breast cyst^[Ref]

Genitourinary

Frequency not reported: Urinary retention, urinary tract infection, dysmenorrhea, dysuria, enuresis, hemoglobinuria, nocturia^[Ref]

Hematologic

Frequency not reported: Eosinophilia, bone marrow depression, agranulocytosis, leukopenia, thrombocytopenia, hemolytic anemia, thrombocythemia, anemia, neutrophil count decreased^[Ref]

Hepatic

Frequency not reported: Jaundice, hepatitis, hepatic abnormality, hyperbilirubinemia, ALT increased, transaminases increased^[Ref]

Musculoskeletal

Frequency not reported: Arthralgia, back pain, myalgia, neck pain, pain in extremity, muscle cramp, joint range of motion decreased^[Ref]

Dermatologic

Frequency not reported: Rash, pruritus, photosensitivity, purpura, sweating, alopecia, face edema, urticaria, hyperhidrosis, cold sweat, skin irritation, dermatitis, erythema, rosacea^[Ref]

Immunologic

Frequency not reported: Hypersensitivity^[Ref]

Metabolic

Frequency not reported: Blood sugar increased, blood sugar decreased, appetite increased, anorexia, appetite decreased, hyperkalemia, hypermagnesemia, hypokalemia^[Ref]

Ocular

Frequency not reported: Vision blurred, angle closure glaucoma, mydriasis, intraocular pressure increased, eye redness, blepharospasm, diplopia, eye pain, lacrimation decreased, eye infection^[Ref]