Esidep Adverse Reactions

Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment.
Tabulated list of adverse reactions: Adverse reactions known for SSRIs and also reported for escitalopram are listed below by system organ class and frequency.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data). (See Table 2.)

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Class effects: An increased risk of bone fractures in patients receiving SSRIs and TCAs has been reported in epidemiological literature, mainly in patients 50 years of age and older. The mechanism leading to this risk is unknown.
Discontinuation symptoms seen when stopping treatment: Discontinuation of SSRIs/SNRIs (particularly when abrupt) commonly leads to discontinuation symptoms. Dizziness, sensory disturbances (including paraesthesia and electric shock sensations), sleep disturbances (including insomnia and intense dreams), agitation or anxiety, nausea and/or vomiting, tremor, confusion, sweating, headache, diarrhoea, palpitations, emotional instability, irritability, and visual disturbances are the most commonly reported reactions. Generally these events are mild to moderate and are self-limiting, however, in some patients they may be severe and/or prolonged. It is therefore advised that when escitalopram treatment is no longer required, gradual discontinuation by dose tapering should be carried out (see Dosage & Administration and Precautions).
QT interval prolongation: Cases of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported during the postmarketing period, predominantly in patients of female gender, with hypokalaemia, or with pre-existing QT interval prolongation or other cardiac diseases (see Contraindications, Precautions, Interactions and Overdosage).
In addition to the adverse events presented above, following adverse events have been reported with escitalopram.
Gastrointestinal disorders: Indigestion, abdominal pain, abdominal cramp, flatulence, toothache, heartburn, gastroenteritis, dysphagia, gastroesophageal reflux, pancreatitis.
Reproductive disorders/female: Menstrual cramps, menstrual disorder.
Respiratory, thoracic and mediastinal disorders: Bronchitis, rhinitis, coughing, nasal congestion, sinus congestion, sinus headache, dyspnea, pulmonary embolism, pulmonary hypertension of the newborn.
Blood and lymphatic system disorders: Anaemia, agranulocytis, aplastic anaemia, haemolytic anaemia, idiopathic thrombocytopenia purpura, leukopenia.
Cardiac disorders: Atrial fibrillation, Cardiac failure, myocardial infarction, hypertension, palpitation.
Ear and labyrinth disorders: Vertigo.
Endocrine disorders: Diabetes mellitus, hyperprolactinaemia.
Eye disorders: Diplopia, glaucoma.
General disorders and administration site conditions: Abnormal gait, asthenia, fall, feeling abnormal, malaise, allergy, chest pain, hot flushes, pain in limb, influenza-like symptoms.
Hepatobiliary disorders: Fulminant hepatitis, hepatic failure, hepatic necrosis.
Immune system disorders: Allergic reaction.
Metabolism and nutrition disorders: Hyperglycaemia, hypoglycaemia.
Musculoskeletal and connective tissue disorders: Muscle cramp, muscle stiffness, muscle weakness, rhabdomyolysis, jaw stiffness, neck/shoulder pain, back pain.
Nervous system disorders: Amnesia, ataxia, choreoathetosis, cerebrovascular accident, dysarthria, dystonia, extrapyramidal disorders, hypoaesthesia, myoclonus, nystagmus, parkinsonism, restless legs, light-headed feeling, migraine.
Pregnancy, puerperium and perinatal conditions: Spontaneous abortion.
Psychiatric disorders: Anger, apathy, completed suicide, depression aggravated, delirium, delusion, disorientation, feeling unreal, mood swings, nervousness, nightmare, paranoia, self-harm or thoughts of self-harm, suicide attempt, concentration impaired, lethargy.
Renal and urinary disorders: Acute renal failure, dysuria, urinary frequency, urinary tract infection.
Skin and subcutaneous tissue disorders: Dermatitis, erythema multiforme, photosensitivity reaction, Stevens Johnson Syndrome, toxic epidermal necrolysis.
Vascular disorders: Deep vein thrombosis, flushing, hypertensive crisis, orthostatic hypotension, phlebitis, thrombosis.
Investigations: Bilirubin increased, hypercholesterolemia, INR increased, prothrombin decreased.