Escitalopram Sandoz 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.
Adverse drug reactions known for SSRIs and also reported for escitalopram in either placebo controlled clinical studies or as spontaneous post-marketing events are listed below by system organ class and frequency.
Frequencies are taken from clinical studies; they are not placebo-corrected. 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); Not known (cannot be estimated from the available data).
Blood and lymphatic system disorders: Not known: Thrombocytopenia.
Immune system disorders: Rare: Anaphylactic reaction.
Endocrine disorders: Not known: Inappropriate ADH secretion.
Metabolism and nutrition disorders: Common: Decreased appetite, increased appetite, weight increased.
Uncommon: Weight decreased.
Not known: Hyponatraemia, anorexia.²
Psychiatric disorders: Common: Anxiety, restlessness, abnormal dreams: Female and male: libido decreased.
Female: anorgasmia.
Uncommon: Bruxism, agitation, nervousness, panic attack, confusional state.
Rare: Aggression, depersonalisation, hallucination.
Not known: Mania, suicidal ideation and suicidal behaviour¹.
Nervous system disorders: Very common: Headache.
Common: Insomnia, somnolence, dizziness, paraesthesia, tremor.
Uncommon: Taste disturbance, sleep disorder, syncope.
Rare: Serotonine syndrome.
Not known: Dyskinesia, movement disorder, convulsion, psychomotor restlessness/akathisia².
Eye disorders: Uncommon: Mydriasis, visual disturbance.
Ear and labyrinth disorders: Uncommon: Tinnitus.
Cardiac disorders: Uncommon: Tachycardia.
Rare: Bradycardia.
Not known: Electrocardiogram QT prolonged, ventricular arrhythmia including torsade de pointes.
Vascular disorders: Not known: Orthostatic hypotension.
Respiratory, thoracic and mediastinal disorders: Common: Sinusitis, yawning.
Uncommon: Epistaxis.
Gastrointestinal disorders: Very common: Nausea.
Common: Diarrhoea, constipation, vomiting, dry mouth.
Uncommon: Gastrointestinal haemorrhages (including rectal haemorrhage).
Hepatobiliary disorders: Not known: Hepatitis, liver function test abnormal.
Skin and subcutaneous tissue disorders: Common: Sweating increased.
Uncommon: Urticaria, alopecia, rash, pruritus.
Not known: Ecchymosis, angioedemas.
Musculoskeletal and connective tissue disorders: Common: Arthralgia, myalgia.
Renal and urinary disorders: Not known: Urinary retention.
Reproductive system and breast disorders: Common: Male: ejaculation disorder, impotence.
Uncommon: Female: metrorrhagia, menorrhagia.
Not known: Galactorrhoea. Male: priapism.
General disorders and administration site conditions: Common: Fatigue, pyrexia.
Uncommon: Oedema.
¹Cases of suicidal ideation and suicidal behaviours have been reported during escitalopram therapy or early after treatment discontinuation (see Precautions).
²These events have been reported for the therapeutic class of SSRIs.
QT interval prolongation: Cases of QT interval prolongation and ventricular arrhythmia including torsade de pointes have been reported during the post-marketing period, predominantly in patients of female gender, with hypokalaemia, or with pre-existing QT interval prolongation or other cardiac diseases (see Contraindications, Precautions, Interactions, Overdose and Pharmacology: Pharmacodynamics under Actions).
Class effects: Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving SSRIs and TCAs. 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).