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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.
Applies to doxepin: oral capsule, oral solution, oral tablet
Oral route (Capsule; Solution)
Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies with major depressive disorder (MDD) and other psychiatric disorders. Short term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or older. This risk must be balanced with the clinical need. Monitor patients 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. Not approved for use in pediatric patients.
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
Get emergency help immediately if any of the following symptoms of overdose occur while taking doxepin:
Symptoms of overdose
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
Applies to doxepin: oral capsule, oral concentrate, oral tablet
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.
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
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
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
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
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
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
Frequency not reported: Gynecomastia, breasts enlarged, galactorrhea, testicular swelling, syndrome of inappropriate antidiuretic hormone
Frequency not reported: Lung adenocarcinoma stage I, malignant melanoma, breast cyst
Frequency not reported: Urinary retention, urinary tract infection, dysmenorrhea, dysuria, enuresis, hemoglobinuria, nocturia
Frequency not reported: Eosinophilia, bone marrow depression, agranulocytosis, leukopenia, thrombocytopenia, hemolytic anemia, thrombocythemia, anemia, neutrophil count decreased
Frequency not reported: Jaundice, hepatitis, hepatic abnormality, hyperbilirubinemia, ALT increased, transaminases increased
Frequency not reported: Arthralgia, back pain, myalgia, neck pain, pain in extremity, muscle cramp, joint range of motion decreased
Frequency not reported: Rash, pruritus, photosensitivity, purpura, sweating, alopecia, face edema, urticaria, hyperhidrosis, cold sweat, skin irritation, dermatitis, erythema, rosacea
Frequency not reported: Hypersensitivity
Frequency not reported: Blood sugar increased, blood sugar decreased, appetite increased, anorexia, appetite decreased, hyperkalemia, hypermagnesemia, hypokalemia
Frequency not reported: Vision blurred, angle closure glaucoma, mydriasis, intraocular pressure increased, eye redness, blepharospasm, diplopia, eye pain, lacrimation decreased, eye infection
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