Adverse reactions : תופעות לוואי

4.8     Undesirable effects

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 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 (≥1/1000 to ≤1/100), rare (≥1/10000 to ≤1/1000), very rare (≤1/10000), or not known (can not be estimated from the available data).

System organ class                   Frequency          Undesirable Effect Blood and lymphatic system           Not Known          Thrombocytopenia disorders
Immune system disorders              Rare               Anaphylactic reaction Endocrine disorders                  Not Known          Inappropriate ADH secretion, Hyperprolactineamia
Metabolism and nutrition             Common             Decreased appetite, increased appetite, disorders                                               Weight increased Uncommon           Weight decreased
Not Known          Hyponatraemia, anorexia1
Psychiatric disorders              Common             Anxiety, restlessness, abnormal dreams libido decreased female: anorgasmia
Uncommon           Bruxism, agitation, nervousness, panic attack, confusional state
Rare               Aggression, depersonalisation, hallucination
Not Known          Mania, suicidal ideation, suicidal behaviour2
Nervous system disorders           Very common        Headache
Common             Insomnia, somnolence, dizziness,
paraesthesia, tremor
Uncommon           Taste disturbance, sleep disorder, syncope
Rare               Serotonin syndrome
Not Known          Dyskinesia, movement disorder, convulsion,
psychomotor restlessness/akathisia1
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          Common             Sinusitis, yawning mediastinal disorders              Uncommon           Epistaxis

Gastroinstestinal 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       Common             Sweating increased disorders                          Uncommon           Urticaria, alopecia, rash, pruritus Not Known          Ecchymosis, angioedemas
Musculo-skeletal and connective    Common             Arthralgia, myalgia tissue disorders                   Not Known          Rhabdomyolysis4 Renal and urinary disorders        Not Known          Urinary retention Reproductive system and breast     Common             Male: ejaculation disorder, impotence disorders                          Uncommon           Female: metrorrhagia, menorrhagia Not Known          Galactorrhoea
Male: priapism
Postpartum haemorrhage³
General disorders and              Common             Fatigue, pyrexia administration site conditions
Uncommon           Oedema


1 These events have been reported for the therapeutic class of SSRIs
2 Cases of suicidal ideation and suicidal behaviours have been reported during escitalopram therapy or early after treatment discontinuation (see section 4.4).
3 This event has been reported for the therapeutic class of SSRIs/SNRIs (see sections 4.4 and 4.6).
4 Cases have been observed during post-marketing use.


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 sections 4.3, 4.4, 4.5, 4.9 and 5.1).

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 section 4.2 and 4.4).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/