Escitalopram oxalate

Escitalopram Side Effects

In 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. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to escitalopram: oral solution, oral tablet

Along with its needed effects, escitalopram 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 escitalopram:

Rare

• Coma
• confusion
• convulsions
• decreased urine output
• dizziness
• fast or irregular heartbeat
• headache
• increased thirst
• muscle pain or cramps
• nausea or vomiting
• shortness of breath
• swelling of the face, ankles, or hands
• unusual tiredness or weakness

Some side effects of escitalopram 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:

More common

• Constipation
• decreased interest in sexual intercourse
• diarrhea
• dry mouth
• ejaculation delay
• gas in the stomach
• heartburn
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• sleepiness or unusual drowsiness
• trouble sleeping

Less common

• Bloated or full feeling
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chills
• cough
• decreased appetite
• excess air or gas in the stomach or intestines
• fever
• general feeling of discomfort or illness
• increased sweating
• joint pain
• muscle aches and pains
• not able to have an orgasm
• pain in the neck or shoulders
• pain or tenderness around the eyes and cheekbones
• passing gas
• runny nose
• shivering
• sneezing
• sore throat
• stuffy nose
• tightness of the chest
• tooth problems
• trouble breathing
• unusual dreams
• unusual drowsiness, dullness, tiredness, weakness or feeling of sluggishness
• yawning

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.

Psychiatric

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.

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

Nervous system

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.

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

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.

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

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

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

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.

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

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

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.

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

Angioedema has been reported with racemic citalopram.

Endocrine

Frequency not reported: Inappropriate antidiuretic hormone secretion (SIADH)

Postmarketing reports: Hyperprolactinemia

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

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

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

Immunologic

Common (1% to 10%): Influenza-like symptoms

Uncommon (0.1% to 1%): Bacterial infection, herpes simplex, herpes zoster, infection, moniliasis, parasitic infection, tuberculosis

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

Epidemiological studies, primarily in patients aged 50 years or older, have shown an increased risk of bone fractures in patients receiving SSRIs or TCAs.

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

Oncologic

Uncommon (0.1% to 1%): Cyst, female breast neoplasm, ovarian cyst

Renal

Uncommon (0.1% to 1%): Pyelonephritis, renal calculus

Postmarketing reports: Acute renal failure

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