Summary
Commonly reported side effects of escitalopram include: diarrhea, drowsiness, ejaculatory disorder, headache, insomnia, nausea, and delayed ejaculation. Other side effects include: anorgasmia, constipation, dizziness, dyspepsia, fatigue, decreased libido, diaphoresis, and xerostomia. Continue reading for a comprehensive list of adverse effects.
Applies to escitalopram: oral solution and tablets.
Warning
-
Suicidality
- Antidepressants increased risk of suicidal thinking and behavior (suicidality) compared with placebo in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.1 12 14 Escitalopram is not approved for use in pediatric patients except for those with major depressive disorder who are ≥12 years of age.1 (See Pediatric Use under Cautions.)
- In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.1 12 14
- Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.1 12 14 15
- Appropriately monitor and closely observe all patients who are started on escitalopram therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.1 12 14 15 (See Worsening of Depression and Suicidality Risk under Cautions.)
Side effects include:
Insomnia, nausea, increased sweating, sexual dysfunction (ejaculation disorder [primarily ejaculatory delay], decreased libido, anorgasmia), fatigue, somnolence.
For Healthcare Professionals
Applies to escitalopram: oral solution, oral tablet.
General
Side effects have been reported to be generally mild and transient. They are most common during the first 2 weeks of treatment and decrease in intensity and frequency with continued treatment. They generally do not lead to treatment cessation.
The overall incidence of rates of side effects in trials with patients treated with escitalopram 10 mg per day (66%) was similar to placebo-treated patients (61%); the incidence rate in the group treated with escitalopram 20 mg per day was greater (86%). Common side effects that occurred in the 20 mg per day group with an incidence approximately twice that of the 10 mg group and approximately twice that of the placebo group included insomnia, diarrhea, dry mouth, somnolence, dizziness, increased sweating, constipation, fatigue, and indigestion.[Ref]
Psychiatric
Very common (10% or more): Insomnia (up to 14%)
Common (1% to 10%): Abnormal dreams, agitation, anxiety, nervousness, restlessness
Uncommon (0.1% to 1%): Abnormal thinking, aggravated depression, aggression/aggressive reaction, aggravated restlessness, alcohol problem, apathy, bruxism, confusion, confusional state, depersonalization, depression, emotional lability, excitability, feeling unreal, forgetfulness, visual/auditory hallucination, hypomania, irritability, jitteriness, obsessive-compulsive disorder, panic attack/reaction, paranoia/paroniria, sleep disorder, suicide attempt, tics
Frequency not reported: Mania, suicidal ideation/behavior
Postmarketing reports: Acute psychosis, anger, completed suicide, delirium, delusion, disorientation, non-accidental overdose, mood swings, nightmare, psychotic disorder, withdrawal syndrome[Ref]
Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. An increased risk of suicidal thinking and behavior in children, adolescents, and young adults (aged 18 to 24 years) with major depressive disorder (MDD) and other psychiatric disorders has been reported with short-term use of antidepressant drugs.
Adult and pediatric patients receiving antidepressants for MDD, as well as for psychiatric and nonpsychiatric indications, have reported symptoms that may be precursors to emerging suicidality, including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Causality has not been established.[Ref]
Nervous system
Very common (10% or more): Headache (up to 24%), somnolence (up to 13%)
Common (1% to 10%): Dizziness, lethargy, paresthesia, tremor
Uncommon (0.1% to 1%): Amnesia, ataxia, carpal tunnel syndrome, cerebrovascular disorder, concentration impairment, dysesthesia, disequilibrium, dysgeusia, dystonia, hyperkinesia, hyperreflexia, hypertonia, hypoesthesia, lightheadedness, migraine, nerve root lesion, neuralgia, neuropathy, paralysis, sedation, syncope, taste alteration/perversion
Rare (less than 0.1%): Serotonin syndrome
Frequency not reported: Abnormal gait, cerebrovascular accident, choreoathetosis, convulsions/seizure, dyskinesia, extrapyramidal disorder, grand mal convulsions/seizures, myoclonus, movement disorder, psychomotor restlessness/akathisia
Postmarketing reports: Dysarthria, neuroleptic malignant syndrome, nystagmus, parkinsonism, restless legs, tardive dyskinesia[Ref]
Convulsions (including grand mal convulsions) have been reported with racemic citalopram.
Potentially life-threatening serotonin syndrome has been reported with SSRIs and SNRIs as monotherapy, but particularly with concomitant use of other serotonergic drugs and drugs that impair the metabolism of serotonin. Serotonin syndrome has been reported with racemic citalopram.
At least one case of escitalopram-induced paroxysmal dystonia has been reported in the literature. A 44-year-old woman developed paroxysmal cervical-cranial dystonia after receiving several days of treatment with escitalopram. The paroxysmal movement disorders were characterized by cervical and oral contracture with sustained and painful laterocollis and twisting tongue movements. The episodes occurred several times a day lasting for several minutes and would resolve spontaneously. The day after escitalopram was discontinued, the paroxysmal symptoms resolved without recurrence.[Ref]
Cardiovascular
Cases of QT interval prolongation and ventricular arrhythmias reported in postmarketing experience were predominantly in females, with hypokalemia, or with pre-existing QT interval prolongation or other cardiac diseases.
Postural hypotension has been reported with other SSRIs.[Ref]
Common (1% to 10%): Palpitation
Uncommon (0.1% to 1%): Abnormal ECG, aggravated hypertension, angina pectoris, bradycardia, chest tightness, chest pain, flushing, hematoma, hot flush, hypertension, hypotension, myocardial infarction, myocardial ischemia, myocarditis, edema, edema of extremities, peripheral edema, peripheral ischemia, tachycardia, traumatic hematoma, varicose vein, vein disorder, vein distended
Frequency not reported: Orthostatic hypotension, prolonged QT, torsades de pointes
Postmarketing reports: Abnormal bleeding, atrial fibrillation, cardiac failure, deep vein thrombosis, hypertensive crisis, phlebitis, postural hypotension, thrombosis, ventricular arrhythmia, ventricular tachycardia[Ref]
Gastrointestinal
Very common (10% or more): Nausea (up to 18.3%), diarrhea (up to 14%)
Common (1% to 10%): Abdominal pain, constipation, dry mouth, dyspepsia, flatulence, indigestion, toothache, vomiting
Uncommon (0.1% to 1%): Abdominal cramp, abdominal discomfort, belching, bloating, change in bowel habit, colitis, enteritis, epigastric discomfort, gastritis, gastrointestinal bleeding, gastrointestinal hemorrhage (including rectal hemorrhage), gastroesophageal reflux, hemorrhoids, heartburn, increased stool frequency, irritable bowel syndrome, melena, periodontal destruction, tooth disorder, ulcerative colitis, ulcerative stomatitis
Frequency not reported: Gastroenteritis
Postmarketing reports: Dysphagia, pancreatitis, stomatitis[Ref]
Metabolic
Common (1% to 10%): Decreased appetite, increased appetite, weight increased
Uncommon (0.1% to 1%): Abnormal glucose tolerance, anorexia, carbohydrate craving, diabetes mellitus, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, thirst, weight decreased
Frequency not reported: Hyponatremia
Postmarketing reports: Hypoglycemia, hypokalemia[Ref]
Numerous cases of hyponatremia have been reported following treatment with an SSRI. Risk factors for the development of SSRI- associated hyponatremia including advanced age, female gender, concomitant use of diuretics, low body weight, and lower baseline serum sodium levels have been identified. Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment. The proposed mechanism for the development of hyponatremia involves SIADH via release of antidiuretic hormone.
A 62-year-old woman developed hyponatremia approximately 3- weeks after initiating treatment with escitalopram. Following discontinuation of the drug and administration of intravenous normal saline solution, the patient's serum sodium and serum and urine osmolality returned to normal levels.
In a similar case, hyponatremia developed in a 75-year-old woman five days after initiating treatment with escitalopram. Following discontinuation of escitalopram serum sodium levels returned to normal values over a period of 5 days. The authors suggest that the risk of hyponatremia is highest during the initial weeks of treatment and is higher in women than in men, in patients 65 years of age or older, and in patients receiving multiple drugs that may also cause hyponatremia.[Ref]
Other
Common (1% to 10%): Fatigue, pyrexia
Uncommon (0.1% to 1%): Abscess, accidental injury, asthenia, bite, burn, deafness, earache, ear disorder, ear infection not otherwise specified, facial edema, fall, food poisoning, fractured neck of femur, hernia, inflicted injury (unintended injury), malaise, otitis externa, otosalpingitis, rigors, sting, surgical intervention, tinnitus, traumatic hematoma, vertigo
Postmarketing reports: Injury not otherwise specified, spontaneous abortion[Ref]
Genitourinary
Very common (10% or more): Ejaculation disorder (up to 14%)
Common (1% to 10%): Anorgasmia, decreased libido, ejaculation failure, impotence, menstrual disorder, vaginal bleeding
Uncommon (0.1% to 1%): Amenorrhea, atrophic vaginitis, breast pain, cystitis, delayed ejaculation, dysmenorrhea, dysuria, genital infection, genital moniliasis, intermenstrual bleeding, loss of libido, menopausal symptoms, menorrhagia, menstrual cramps, metrorrhagia, micturition disorder, micturition frequency, nocturia, polyuria, postmenopausal bleeding, premenstrual tension, prostatic disorder, sexual function abnormality, unintended pregnancy, urinary frequency, urinary incontinence, urinary retention, urinary tract infection, uterine fibroid, vaginal candidiasis, vaginal hemorrhage, vaginitis
Frequency not reported: Galactorrhea, priapism[Ref]
Urinary retention and galactorrhea have been reported with other SSRIs. The estimates of the incidence of untoward sexual experience and performance may underestimate their actual incidence, partly because patients and physicians may be reluctant to discuss this issue.[Ref]
Dermatologic
Common (1% to 10%): Increased sweating
Uncommon (0.1% to 1%): Acne, aggravated psoriasis, alopecia, cellulitis, dry skin, eczema, erythematous rash, fungal dermatitis, furunculosis, hematomas, lichenoid dermatitis, onychomycosis, pruritus, purpura, pustular rash, rash, scar, skin disorder, urticaria, verruca
Frequency not reported: Angioedema, ecchymosis
Postmarketing reports: Epidermal necrolysis, erythema multiforme, Stevens Johnson syndrome, toxic epidermal necrolysis[Ref]
Angioedema has been reported with racemic citalopram.[Ref]
Endocrine
Frequency not reported: Inappropriate antidiuretic hormone secretion (SIADH)
Postmarketing reports: Hyperprolactinemia[Ref]
Hematologic
Uncommon (0.1% to 1%): Anemia, hypochromic anemia, leucopenia
Frequency not reported: Thrombocytopenia
Postmarketing reports: Agranulocytosis, aplastic anemia, decreased prothrombin, hemolytic anemia, idiopathic thrombocytopenia purpura, increased INR[Ref]
Hepatic
Uncommon (0.1% to 1%): Bilirubinemia, hepatic enzymes increased
Postmarketing reports: Abnormal liver function tests, fulminant hepatitis, hepatic failure, hepatic necrosis, hepatitis, increased bilirubin[Ref]
Hypersensitivity
Uncommon (0.1% to 1%): Aggravated allergy, allergic reactions
Rare (less than 0.1%): Anaphylaxis/anaphylactic reaction
Postmarketing reports: Hypersensitivity not otherwise specified, photosensitivity reaction[Ref]
Immunologic
Common (1% to 10%): Influenza-like symptoms
Uncommon (0.1% to 1%): Bacterial infection, herpes simplex, herpes zoster, infection, moniliasis, parasitic infection, tuberculosis[Ref]
Musculoskeletal
Common (1% to 10%): Arthralgia, back pain, myalgia, neck/shoulder pain
Uncommon (0.1% to 1%): Arthritis, arthropathy, arthrosis, bursitis, costochondritis, fibromyalgia, ischial neuralgia, jaw stiffness, leg pain, limb pain, leg cramps, lumbar disc lesion, muscle contractions, muscle cramp, muscle spasms, muscle stiffness, muscle tightness, muscle weakness, myopathy, osteoporosis, plantar fasciitis, tendinitis, tenosynovitis, tetany, twitching
Postmarketing reports: Rhabdomyolysis[Ref]
Epidemiological studies, primarily in patients aged 50 years or older, have shown an increased risk of bone fractures in patients receiving SSRIs or TCAs.[Ref]
Ocular
Uncommon (0.1% to 1%): Abnormal accommodation, abnormal vision, blepharospasm, blurred vision, dry eyes, eye infection, eye irritation, eye pain, mydriasis, ocular hemorrhage, visual disturbance, xerophthalmia
Postmarketing reports: Angle closure glaucoma, diplopia[Ref]
Oncologic
Uncommon (0.1% to 1%): Cyst, female breast neoplasm, ovarian cyst[Ref]
Renal
Uncommon (0.1% to 1%): Pyelonephritis, renal calculus
Postmarketing reports: Acute renal failure[Ref]
Respiratory
Common (1% to 10%): Pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, yawning
Uncommon (0.1% to 1%): Asthma, bronchitis, coughing, dyspnea, epistaxis, laryngitis, nasal congestion, nasopharyngitis, pneumonia, respiratory tract infection, shortness of breath, sinus congestion, sinus headache, sleep apnea, snoring, tracheitis, throat tightness
Postmarketing reports: Pulmonary embolism, pulmonary hypertension of the newborn[Ref]