Lexapro Side Effects
Please note - some side effects for Lexapro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Lexapro - for the Consumer
Lexapro
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lexapro:
Seek medical attention right away if any of these SEVERE side effects occur when using Lexapro:Constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; light-headedness when you stand or sit up; loss of appetite; nausea; stomach upset; tiredness; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; fainting; fast, slow, or irregular heartbeat; hallucinations; memory loss; menstrual period changes; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears;persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe dizziness; severe or persistent anxiety or trouble sleeping; severe or persistent headache; shortness of breath; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vision changes; worsening of depression.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Lexapro Solution
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Lexapro Solution:
Seek medical attention right away if any of these SEVERE side effects occur when using Lexapro Solution:Constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; light-headedness when you stand or sit up; loss of appetite; nausea; stomach upset; tiredness; trouble sleeping.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bizarre behavior; black or bloody stools; chest pain; confusion; decreased concentration; decreased coordination; fainting; fast, slow, or irregular heartbeat; hallucinations; memory loss; menstrual period changes; new or worsening agitation, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, restlessness, or inability to sit still; persistent or severe ringing in the ears;persistent, painful erection; red, swollen, blistered, or peeling skin; seizures; severe dizziness; severe or persistent anxiety or trouble sleeping; severe or persistent headache; shortness of breath; stomach pain; suicidal thoughts or attempts; tremor; unusual bruising or bleeding; unusual or severe mental or mood changes; unusual weakness; vision changes; worsening of depression.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopLexapro Side Effects - for the Professional
Lexapro
Clinical Trials Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Clinical Trial Data Sources
Pediatrics (6 -17 years)
Adverse events were collected in 576 pediatric patients (286 Lexapro, 290 placebo) with major depressive disorder in double-blind placebo-controlled studies. Safety and effectiveness of Lexapro in pediatric patients less than 12 years of age has not been established.
Adults
Adverse events information for Lexapro was collected from 715 patients with major depressive disorder who were exposed to escitalopram and from 592 patients who were exposed to placebo in double-blind, placebo-controlled trials. An additional 284 patients with major depressive disorder were newly exposed to escitalopram in open-label trials. The adverse event information for Lexapro in patients with GAD was collected from 429 patients exposed to escitalopram and from 427 patients exposed to placebo in double-blind, placebo-controlled trials.
Adverse events during exposure were obtained primarily by general inquiry and recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of events into a smaller number of standardized event categories. In the tables and tabulations that follow, standard World Health Organization (WHO) terminology has been used to classify reported adverse events.
The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment-emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.
Adverse Events Associated with Discontinuation of Treatment
Major Depressive Disorder
Pediatrics (6 -17 years)
Adverse events were associated with discontinuation of 3.5% of 286 patients receiving Lexapro and 1% of 290 patients receiving placebo. The most common adverse event (incidence at least 1% for Lexapro and greater than placebo) associated with discontinuation was insomnia (1% Lexapro, 0% placebo).
Adults
Among the 715 depressed patients who received Lexapro in placebo-controlled trials, 6% discontinued treatment due to an adverse event, as compared to 2% of 592 patients receiving placebo. In two fixed-dose studies, the rate of discontinuation for adverse events in patients receiving 10 mg/day Lexapro was not significantly different from the rate of discontinuation for adverse events in patients receiving placebo. The rate of discontinuation for adverse events in patients assigned to a fixed dose of 20 mg/day Lexapro was 10%, which was significantly different from the rate of discontinuation for adverse events in patients receiving 10 mg/day Lexapro (4%) and placebo (3%). Adverse events that were associated with the discontinuation of at least 1% of patients treated with Lexapro, and for which the rate was at least twice that of placebo, were nausea (2%) and ejaculation disorder (2% of male patients).
Generalized Anxiety Disorder
Adults
Among the 429 GAD patients who received Lexapro 10-20 mg/day in placebo-controlled trials, 8% discontinued treatment due to an adverse event, as compared to 4% of 427 patients receiving placebo. Adverse events that were associated with the discontinuation of at least 1% of patients treated with Lexapro, and for which the rate was at least twice the placebo rate, were nausea (2%), insomnia (1%), and fatigue (1%).
Incidence of Adverse Reactions in Placebo-Controlled Clinical Trials
Major Depressive Disorder
Pediatrics (6 -17 years)
The overall profile of adverse reactions in pediatric patients was generally similar to that seen in adult studies, as shown in Table 2. However, the following adverse reactions (excluding those which appear in Table 2 and those for which the coded terms were uninformative or misleading) were reported at an incidence of at least 2% for Lexapro and greater than placebo: back pain, urinary tract infection, vomiting, and nasal congestion.
Adults
The most commonly observed adverse reactions in Lexapro patients (incidence of approximately 5% or greater and approximately twice the incidence in placebo patients) were insomnia, ejaculation disorder (primarily ejaculatory delay), nausea, sweating increased, fatigue, and somnolence.
Table 2 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse events that occurred among 715 depressed patients who received Lexapro at doses ranging from 10 to 20 mg/day in placebo-controlled trials. Events included are those occurring in 2% or more of patients treated with Lexapro and for which the incidence in patients treated with Lexapro was greater than the incidence in placebo-treated patients.
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1Primarily ejaculatory delay. |
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|
2Denominator used was for males only (N=225 Lexapro; N=188 placebo). |
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3Denominator used was for females only (N=490 Lexapro; N=404 placebo). |
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| Adverse Reaction | Lexapro | Placebo |
| (N=715) % |
(N=592) % |
|
| Autonomic Nervous System Disorders | ||
| Dry Mouth | 6% | 5% |
| Sweating Increased | 5% | 2% |
| Central & Peripheral Nervous System Disorders | ||
| Dizziness | 5% | 3% |
| Gastrointestinal Disorders | ||
| Nausea | 15% | 7% |
| Diarrhea | 8% | 5% |
| Constipation | 3% | 1% |
| Indigestion | 3% | 1% |
| Abdominal Pain | 2% | 1% |
| General | ||
| Influenza-like Symptoms | 5% | 4% |
| Fatigue | 5% | 2% |
| Psychiatric Disorders | ||
| Insomnia | 9% | 4% |
| Somnolence | 6% | 2% |
| Appetite Decreased | 3% | 1% |
| Libido Decreased | 3% | 1% |
| Respiratory System Disorders | ||
| Rhinitis | 5% | 4% |
| Sinusitis | 3% | 2% |
| Urogenital | ||
| Ejaculation Disorder1,2 | 9% | <1% |
| Impotence2 | 3% | <1% |
| Anorgasmia3 | 2% | <1% |
Generalized Anxiety Disorder
Adults
The most commonly observed adverse reactions in Lexapro patients (incidence of approximately 5% or greater and approximately twice the incidence in placebo patients) were nausea, ejaculation disorder (primarily ejaculatory delay), insomnia, fatigue, decreased libido, and anorgasmia.
Table 3 enumerates the incidence, rounded to the nearest percent of treatment-emergent adverse events that occurred among 429 GAD patients who received Lexapro 10 to 20 mg/day in placebo-controlled trials. Events included are those occurring in 2% or more of patients treated with Lexapro and for which the incidence in patients treated with Lexapro was greater than the incidence in placebo-treated patients.
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1Primarily ejaculatory delay. |
||
|
2Denominator used was for males only (N=182 Lexapro; N=195 placebo). |
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|
3Denominator used was for females only (N=247 Lexapro; N=232 placebo). |
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| Adverse Reactions | Lexapro | Placebo |
| (N=429) % |
(N=427) % |
|
| Autonomic Nervous System Disorders | ||
| Dry Mouth | 9% | 5% |
| Sweating Increased | 4% | 1% |
| Central & Peripheral Nervous System Disorders | ||
| Headache | 24% | 17% |
| Paresthesia | 2% | 1% |
| Gastrointestinal Disorders | ||
| Nausea | 18% | 8% |
| Diarrhea | 8% | 6% |
| Constipation | 5% | 4% |
| Indigestion | 3% | 2% |
| Vomiting | 3% | 1% |
| Abdominal Pain | 2% | 1% |
| Flatulence | 2% | 1% |
| Toothache | 2% | 0% |
| General | ||
| Fatigue | 8% | 2% |
| Influenza-like Symptoms | 5% | 4% |
| Musculoskeletal System Disorder | ||
| Neck/Shoulder Pain | 3% | 1% |
| Psychiatric Disorders | ||
| Somnolence | 13% | 7% |
| Insomnia | 12% | 6% |
| Libido Decreased | 7% | 2% |
| Dreaming Abnormal | 3% | 2% |
| Appetite Decreased | 3% | 1% |
| Lethargy | 3% | 1% |
| Respiratory System Disorders | ||
| Yawning | 2% | 1% |
| Urogenital | ||
| Ejaculation Disorder1,2 | 14% | 2% |
| Anorgasmia3 | 6% | <1% |
| Menstrual Disorder | 2% | 1% |
Dose Dependency of Adverse Reactions
The potential dose dependency of common adverse reactions (defined as an incidence rate of ≥5% in either the 10 mg or 20 mg Lexapro groups) was examined on the basis of the combined incidence of adverse reactions in two fixed-dose trials. The overall incidence rates of adverse events in 10 mg Lexapro-treated patients (66%) was similar to that of the placebo-treated patients (61%), while the incidence rate in 20 mg/day Lexapro-treated patients was greater (86%). Table 4 shows common adverse reactions that occurred in the 20 mg/day Lexapro group with an incidence that was approximately twice that of the 10 mg/day Lexapro group and approximately twice that of the placebo group.
| Adverse Reaction | Placebo | 10 mg/day | 20 mg/day |
| (N=311) | Lexapro | Lexapro | |
| (N=310) | (N=125) | ||
| Insomnia | 4% | 7% | 14% |
| Diarrhea | 5% | 6% | 14% |
| Dry Mouth | 3% | 4% | 9% |
| Somnolence | 1% | 4% | 9% |
| Dizziness | 2% | 4% | 7% |
| Sweating Increased | <1% | 3% | 8% |
| Constipation | 1% | 3% | 6% |
| Fatigue | 2% | 2% | 6% |
| Indigestion | 1% | 2% | 6% |
Male and Female Sexual Dysfunction with SSRIs
Although changes in sexual desire, sexual performance, and sexual satisfaction often occur as manifestations of a psychiatric disorder, they may also be a consequence of pharmacologic treatment. In particular, some evidence suggests that SSRIs can cause such untoward sexual experiences.
Reliable estimates of the incidence and severity of untoward experiences involving sexual desire, performance, and satisfaction are difficult to obtain, however, in part because patients and physicians may be reluctant to discuss them. Accordingly, estimates of the incidence of untoward sexual experience and performance cited in product labeling are likely to underestimate their actual incidence.
| Adverse Event | Lexapro | Placebo |
| In Males Only | ||
| (N=407) | (N=383) | |
| Ejaculation Disorder (primarily ejaculatory delay) |
12% |
1% |
| Libido Decreased | 6% | 2% |
| Impotence | 2% | <1% |
| In Females Only | ||
| (N=737) | (N=636) | |
| Libido Decreased | 3% | 1% |
| Anorgasmia | 3% | <1% |
There are no adequately designed studies examining sexual dysfunction with escitalopram treatment.
Priapism has been reported with all SSRIs.
While it is difficult to know the precise risk of sexual dysfunction associated with the use of SSRIs, physicians should routinely inquire about such possible side effects.
Vital Sign Changes
Lexapro and placebo groups were compared with respect to (1) mean change from baseline in vital signs (pulse, systolic blood pressure, and diastolic blood pressure) and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses did not reveal any clinically important changes in vital signs associated with Lexapro treatment. In addition, a comparison of supine and standing vital sign measures in subjects receiving Lexapro indicated that Lexapro treatment is not associated with orthostatic changes.
Weight Changes
Patients treated with Lexapro in controlled trials did not differ from placebo-treated patients with regard to clinically important change in body weight.
Laboratory Changes
Lexapro and placebo groups were compared with respect to (1) mean change from baseline in various serum chemistry, hematology, and urinalysis variables, and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed no clinically important changes in laboratory test parameters associated with Lexapro treatment.
ECG Changes
Electrocardiograms from Lexapro (N=625), racemic citalopram (N=351), and placebo (N=527) groups were compared with respect to (1) mean change from baseline in various ECG parameters and (2) the incidence of patients meeting criteria for potentially clinically significant changes from baseline in these variables. These analyses revealed (1) a decrease in heart rate of 2.2 bpm for Lexapro and 2.7 bpm for racemic citalopram, compared to an increase of 0.3 bpm for placebo and (2) an increase in QTc interval of 3.9 msec for Lexapro and 3.7 msec for racemic citalopram, compared to 0.5 msec for placebo. Neither Lexapro nor racemic citalopram were associated with the development of clinically significant ECG abnormalities.
Other Reactions Observed During the Premarketing Evaluation of Lexapro
Following is a list of treatment-emergent adverse events, as defined in the introduction to the ADVERSE REACTIONS section, reported by the 1428 patients treated with Lexapro for periods of up to one year in double-blind or open-label clinical trials during its premarketing evaluation. The listing does not include those events already listed in Tables 2 & 3, those events for which a drug cause was remote and at a rate less than 1% or lower than placebo, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial probability of being acutely life threatening. Events are categorized by body system. Events of major clinical importance are described in the Warnings and Precautions section (5).
Cardiovascular - hypertension, palpitation.
Central and Peripheral Nervous System Disorders - light-headed feeling, migraine.
Gastrointestinal Disorders - abdominal cramp, heartburn, gastroenteritis.
General - allergy, chest pain, fever, hot flushes, pain in limb.
Metabolic and Nutritional Disorders - increased weight.
Musculoskeletal System Disorders - arthralgia, myalgia jaw stiffness.
Psychiatric Disorders - appetite increased, concentration impaired, irritability.
Reproductive Disorders/Female - menstrual cramps, menstrual disorder.
Respiratory System Disorders - bronchitis, coughing, nasal congestion, sinus congestion, sinus headache.
Skin and Appendages Disorders - rash.
Special Senses - vision blurred, tinnitus.
Urinary System Disorders - urinary frequency, urinary tract infection.
Post-Marketing Experience
Adverse Reactions Reported Subsequent to the Marketing of Escitalopram
The following additional adverse reactions have been identified from spontaneous reports of escitalopram received worldwide. These adverse reactions have been chosen for inclusion because of a combination of seriousness, frequency of reporting, or potential causal connection to escitalopram and have not been listed elsewhere in labeling. However, because these adverse reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events include:
Blood and Lymphatic System Disorders: anemia, agranulocytis, aplastic anemia, hemolytic anemia, idiopathic thrombocytopenia purpura, leukopenia, thrombocytopenia.
Cardiac Disorders: atrial fibrillation, bradycardia, cardiac failure, myocardial infarction, tachycardia, torsade de pointes, ventricular arrhythmia, ventricular tachycardia.
Ear and labyrinth disorders: vertigo
Endocrine Disorders: diabetes mellitus, hyperprolactinemia, SIADH.
Eye Disorders: diplopia, glaucoma, mydriasis, visual disturbance.
Gastrointestinal Disorder: dysphagia, gastrointestinal hemorrhage, gastroesophageal reflux, pancreatitis, rectal hemorrhage.
General Disorders and Administration Site Conditions: abnormal gait, asthenia, edema, fall, feeling abnormal, malaise.
Hepatobiliary Disorders: fulminant hepatitis, hepatic failure, hepatic necrosis, hepatitis.
Immune System Disorders: allergic reaction, anaphylaxis.
Investigations: bilirubin increased, decreased weight, electrocardiogram QT prolongation, hepatic enzymes increased,hypercholesterolemia, INR increased, prothrombin decreased.
Metabolism and Nutrition Disorders: hyperglycemia, hypoglycemia, hypokalemia, hyponatremia.
Musculoskeletal and Connective Tissue Disorders: muscle cramp, muscle stiffness, muscle weakness, rhabdomyolysis.
Nervous System Disorders: akathisia, amnesia, ataxia, choreoathetosis, cerebrovascular accident, dysarthria, dyskinesia, dystonia, extrapyramidal disorders, grand mal seizures (or convulsions), hypoaesthesia, myoclonus, nystagmus, Parkinsonism, restless legs, seizures, syncope, tardive dyskinesia, tremor.
Pregnancy, Puerperium and Perinatal Conditions: spontaneous abortion.
Psychiatric Disorders: acute psychosis, aggression, agitation, anger, anxiety, apathy, completed suicide, confusion, depersonalization, depression aggravated, delirium, delusion, disorientation, feeling unreal, hallucinations (visual and auditory), mood swings, nervousness, nightmare, panic reaction, paranoia, restlessness, self-harm or thoughts of self-harm, suicide attempt, suicidal ideation, suicidal tendency.
Renal and Urinary Disorders: acute renal failure, dysuria, urinary retention.
Reproductive System and Breast Disorders: menorrhagia, priapism.
Respiratory, Thoracic and Mediastinal Disorders: dyspnea, epistaxis, pulmonary embolism, pulmonary hypertension of the newborn.
Skin and Subcutaneous Tissue Disorders: alopecia, angioedema, dermatitis, ecchymosis, erythema multiforme, photosensitivity reaction, Stevens Johnson Syndrome, toxic epidermal necrolysis, urticaria.
Vascular Disorders: deep vein thrombosis, flushing, hypertensive crisis, hypotension, orthostatic hypotension, phlebitis, thrombosis.
TopSide Effects by Body System - for Healthcare Professionals
Nervous system
Nearly all selective serotonin reuptake inhibitors, mixed serotonin/norepinephrine reuptake inhibitors, and tricyclic antidepressants cause sleep abnormalities to some extent. These antidepressants have marked dose-dependent effects on rapid eye movement (REM) sleep, causing reductions in the overall amount of REM sleep over the night and delays the first entry into REM sleep (increased REM sleep onset latency (ROL)), both in healthy subjects and depressed patients. The antidepressants that increase serotonin function appear to have the greatest effect on REM sleep. The reduction in REM sleep is greatest early in treatment, but gradually returns towards baseline during long-term therapy; however, ROL remains long. Following discontinuation of therapy the amount of REM sleep tends to rebound. Some of these drugs (i.e., bupropion, mirtazapine, nefazodone, trazodone, trimipramine) appear to have a modest or minimal effect on REM sleep.
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.
Nervous system side effects have been reported. In two fixed dose trials, dry mouth was reported at 4% with a dose of 10 mg/day and 9% with a dose of 20 mg/day. In those same two fixed dose trials, somnolence was reported at 4% with a dose of 10 mg/day and 9% with a dose of 20 mg/day. Additionally, dizziness was reported at 4% with a dose of 10 mg/day and 7% with a dose of 20 mg/day. Furthermore, increased sweating was reported at 3% with a dose of 10 mg/day and 8% with a dose of 20 mg/day. Paresthesia, light- headed feeling, migraine, tremor, sleep abnormalities, and vertigo have been reported frequently. Shaking, disequilibrium, tics, restless legs, carpal tunnel syndrome, twitching, faintness, hyperreflexia, muscle, involuntary muscle contractions, and increased muscle tone have been reported infrequently. Dystonia, extrapyramidal disorders, grand mal seizures, and seizures have been reported; however, a causal relationship with escitalopram has not been determined.
Nervous system side effects reported during 6 months of continuous therapy (10 to 20 mg daily) have included headache (25%), insomnia (15%), and somnolence (11%).
Gastrointestinal
Gastrointestinal side effects including nausea (15%) and abdominal pain (2%) have been reported. In two fixed dose trials, diarrhea was reported at 6% with a dose of 10 mg/day and 14% with a dose of 20 mg/day. In those same two fixed dose trials, constipation was reported at 3% with a dose of 10 mg/day and 6% with a dose of 20 mg/day. Furthermore, indigestion was reported at 2% with a dose of 10 mg/day and 6% with a dose of 20 mg/day. Vomiting, flatulence, heartburn, toothache, gastroenteritis, abdominal cramping, and gastroesophageal reflux have been reported frequently. Bloating, increased stool frequency, abdominal discomfort, dyspepsia, belching, gagging, gastritis, and hemorrhoids have been reported infrequently. Gastrointestinal hemorrhage and rectal hemorrhage have been reported; however, a causal relationship with escitalopram has not been determined.
Gastrointestinal side effects reported during 6 months of continuous therapy (10 to 20 mg daily) have included nausea (15%), diarrhea (11%), and dry mouth (11%).
General
General side effects including influenza-like symptoms (5%) and fatigue (5%) have been reported. In two fixed dose trials, insomnia was reported at 7% with a dose of 10 mg/day and 14% with a dose of 20 mg/day. In those same two fixed dose trials, fatigue was reported at 2% with a dose of 10 mg/day and 6% with a dose of 20 mg/day. Allergy, limb pain, increased or decreased weight, hot flushes, fever, and chest pain have been reported frequently. Edema of the extremities, bruise, nosebleed, chills, malaise, syncope, chest tightness, leg pain, edema, and asthenia have been reported infrequently.
Psychiatric
Psychiatric side effects including insomnia (9%), somnolence (6%), decreased appetite (3%), and decreased libido (3%) have been reported. Abnormal dreaming, yawning, increased appetite, lethargy, irritability, and impaired concentration have been reported frequently. Agitation, jitteriness, apathy, panic reaction, aggravated restlessness, nervousness, forgetfulness, attempted suicide, aggravated depression, feeling unreal, excitability, emotional lability, abnormal crying, depression, anxiety attack, depersonalization, suicidal tendency, bruxism, confusion, carbohydrate craving, amnesia, nervous tremulousness, and auditory hallucinations have been reported infrequently. Aggression, acute psychosis, and visual hallucinations have been reported; however, a causal relationship with escitalopram has not been determined.
Respiratory
Respiratory side effects including rhinitis (5%) and sinusitis (3%) have been reported. Bronchitis, sinus congestion, coughing, sinus headache, and nasal congestion have been reported frequently. Asthma, shortness of breath, laryngitis, pneumonia, and tracheitis have been reported infrequently. Pulmonary embolism has been reported; however, a causal relationship with escitalopram has not been determined.
Respiratory side effects reported during 6 months of continuous therapy (10 to 20 mg daily) have included upper respiratory tract infection (15%) and rhinitis (10%).
Genitourinary
Genitourinary side effects including urinary tract infection and urinary frequency have been reported frequently. Kidney stones, dysuria, and urinary urgency have been reported infrequently. In male patients ejaculatory disorder (primarily ejaculatory delay) (9%), decreased libido (4%), and impotence (3%) have been reported. Priapism has been reported with the use of all selective serotonin reuptake inhibitors. Genitourinary side effects in female patients have included decreased libido (2%) and anorgasmia (2%). Menstrual disorder, menorrhagia, spotting between menses, and pelvic inflammation has been reported infrequently.
Genitourinary side effects reported during 6 months of continuous therapy have included ejaculation disorder (16%) and decreased libido (10%).
Cardiovascular
Cardiovascular side effects including palpitation and hypertension have been reported frequently. Bradycardia, tachycardia, ECG abnormalities, flushing, and varicose veins have been reported infrequently. Angioedema, cardiac failure, deep vein thrombosis phlebitis thrombosis, atrial fibrillation, hypotension, myocardial infarction, orthostatic hypotension, QT prolongation, torsades de pointes, and ventricular tachycardia have been reported; however, a causal relationship with escitalopram has not been determined.
Hypersensitivity
Hypersensitivity side effects including anaphylaxis have been reported infrequently.
Hematologic
Hematologic side effects including anemia and hematoma have been reported infrequently. Thrombocytopenia has been reported; however, a causal relationship with escitalopram has not been determined. Escitalopram does appear to inhibit platelet aggregation at therapeutic concentrations in vitro.
Metabolic
Metabolic side effects including increased bilirubin, gout, hypercholesterolemia, and hyperglycemia have been reported infrequently. Serotonin syndrome has been reported; however, a causal relationship with escitalopram has not been determined.
Musculoskeletal
Musculoskeletal side effects including arthralgia, neck/shoulder pain, muscle cramp, and myalgia have been reported frequently. Jaw stiffness, muscle stiffness, arthritis, muscle weakness, arthropathy, back discomfort, joint stiffness, and jaw pain have been reported infrequently. Rhabdomyolysis has been reported; however, a causal relationship with escitalopram has not been determined.
Dermatologic
Dermatologic side effects including rash have been reported frequently. Acne, pruritus, eczema, alopecia, dry skin, folliculitis, lipoma, furunculosis, and dermatitis have been reported infrequently. Toxic epidermal necrolysis and urticaria have been reported; however, a causal relationship with escitalopram has not been determined. In addition, an intraoral lichenoid reaction on the buccal mucosa along with a dark pigmentation on the lower lip have been reported following use of escitalopram.
Ocular
Ocular side effects including blurred vision have been reported frequently. Eye irritation, conjunctivitis, abnormal vision, visual disturbance, dry eyes, eye infection, and dilated pupils have been reported infrequently. Diplopia has been reported; however, a causal relationship with escitalopram has not been determined.
According to one case report, use of escitalopram resulted in uveal effusions and caused acute bilateral angle closure glaucoma in a 41- year- old woman.
Other
Otic side effects including ear ache and tinnitus have been reported. Abnormal gait and neuroleptic malignant syndrome has also been reported; however, causality has not been established.
Other
Other side effects including taste alteration have been reported infrequently.
Hepatic
Hepatic side effects have included hepatitis; however, a causal relationship with escitalopram has not been determined.
Renal
Renal side effects have included acute renal failure; however, a causal relationship with escitalopram has not been determined.
Endocrine
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.
Numerous cases of hyponatremia have been reported following treatment with a selective serotonin reuptake inhibitor (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 the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) via release of antidiuretic hormone.
Endocrine side effects have included pancreatitis, diabetes mellitus, hyperprolactinemia, and hyponatremia secondary to the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). However, a causal relationship with escitalopram has not been determined.
TopMore Lexapro resources
- Lexapro Prescribing Information (FDA)
- Lexapro Monograph (AHFS DI)
- Lexapro Advanced Consumer (Micromedex) - Includes Dosage Information
- Lexapro MedFacts Consumer Leaflet (Wolters Kluwer)
- Lexapro Consumer Overview
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