Adverse events

Like all antidepressants, Cipralex is associated with side effects that range from very common to rare. Adverse reactions are most frequent during the first or second week of treatment and usually decrease in intensity and frequency with continued treatment. (ref.1)

Very common to common 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. For adverse reactions that are rare, very rare, uncommon or not known, please refer to the prescribing information.

Frequencies are taken from clinical studies; they are not placebo-corrected. Frequencies listed below are defined as: very common (≥1/10) or common (≥1/100 to <1/10).</p>

System organ class	Frequency	Undesirable Effect
Metabolism and nutrition disorders	Common	Decreased appetite, increased appetite, weight increased
Psychiatric disorders	Common	Anxiety, restlessness, abnormal dreams Female and male: libido decreased Female: anorgasmia
Nervous system disorders	Common	Insomnia, somnolence, dizziness, paraesthesia, tremor
Respiratory, thoracic and mediastinal disorders	Common	Sinusitis, yawning
Gastrointestinal disorders	Very common	Nausea
	Common	Diarrhoea, constipation, vomiting, dry mouth
Skin and subcutaneous tissue disorders	Common	Sweating increased
Musculoskeletal and connective tissue disorders	Common	Arthralgia, myalgia
Reproductive system and breast disorders	Common	Male: ejaculation disorder, impotence
General disorders and administration site conditions	Common	Fatigue, pyrexia

Cases of QT-prolongation have been reported during the post-marketing period, predominantly in patients with pre-existing cardiac disease. In a double-blind, placebo-controlled ECG study in healthy subjects, the change from baseline in QTc (Fridericia-correction) was 4.3 ms (90% CI: 2.2, 6.4) at the 10 mg/day dose and 10.7 ms (90% CI: 8.6, 12.8) at the supratherapeutic dose 30 mg/day.

Nausea

The most common side effect of Cipralex treatment is nausea. In most cases, the feelings of nausea are mild and tend to disappear within 14 days.

In fact, studies have shown that after approximately 14 days, Cipralex is no more likely to cause nausea than a placebo tablet.

Mean prevalence of nausea per day (%) (ref.1)

References:

1. Wade et al. Int Clin Psychopharm 2002;17(3):95-102

2. Baldwin et al. Ann Pharmacother 2007;41:1583-1592

3. Escitalopram SPC