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 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, connective       Common            Arthralgia, myalgia tissue disorders
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 haemorrage3
General disorders and              Common            Fatigue, pyrexia administration site conditions
Uncommon          Oedema


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

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 hypokalemia, 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/