SEROQUEL side effects

The data presented here are from the Summary of Product Characteristics for Ireland. As regulatory conditions differ from country to country, please refer to the Summary of Product Characteristics for your home country.

Safety information for Seroquel XR can be found in the Summary of Product Characteristics (SmPC).

• Download the Seroquel XR product information in pdf format.

Undesirable effects

This is an extract from SEROQUEL XR SmPC for Ireland

The most commonly reported Adverse Drug Reactions (ADRs) with quetiapine are somnolence, dizziness, dry mouth, mild asthenia, constipation, tachycardia, orthostatic hypotension and dyspepsia. 

As with other antipsychotics, weight gain, syncope, neuroleptic malignant syndrome, leucopenia, neutropenia and peripheral oedema, have been associated with quetiapine.

The incidences of ADRs associated with quetiapine therapy, are tabulated below according to the format recommended by the Council for International Organizations of Medical Sciences (CIOMS III Working Group 1995).

The frequencies of adverse events are ranked according to the following:
Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000) and very rare (<1/10,000).

1. See Section 4.4 of SmPC
2. Somnolence may occur, usually during the first two weeks of treatment and generally resolves with the continued administration of quetiapine.
3. Asymptomatic elevations in serum transaminase (ALT, AST) or gamma-GT-levels have been observed in some patients administered quetiapine. These elevations were usually reversible on continued quetiapine treatment.
4. As with other antipsychotics with alpha1 adrenergic blocking activity, quetiapine may commonly induce orthostatic hypotension, associated with dizziness, tachycardia and, in some patients, syncope, especially during the initial dose-titration period. (See section 4.4 of SmPC).
5. Exacerbation of pre-existing diabetes has been reported in very rare cases.
6. Calculation of Frequency for these ADR’s have only been taken from postmarketing data with the immediate release formulation of Seroquel.
7. Fasting blood glucose ≥126mg/dL (≥7.0 mmol/L) or a non fasting blood glucose ≥200 mg/dL (≥11.1 mmol/L) on at least one occasion
8. An increase in the rate of dysphagia with quetiapine vs. placebo was only observed in the clinical trials in bipolar depression.
9. Based on >7% increase in body weight from baseline. Occurs predominantly during the early weeks of treatment in adults.
10. The following withdrawal symptoms have been observed most frequently in acute placebo-controlled, monotherapy clinical trials, which evaluated discontinuation symptoms: insomnia, nausea, headache, diarrhoea, vomiting, dizziness, and irritability. The incidence of these reactions had decreased significantly after 1 week post-discontinuation.
11. Triglycerides ≥200 mg/dL (≥2.258 mmol/L) (patients ≥18 years of age) or ≥150 mg/dL (≥1.694 mmol/L) (patients <18 years of age) on at least one occasion.
12. Cholesterol ≥240 mg/dL (≥6.2064 mmol/L) (patients ≥18 years of age) or ≥200 mg/dL (≥5.172 mmol/L) (patients <18 years of age) on at least one occasion. An increase in LDL cholesterol of ≥30 mg/dL (≥0.769 mmol/L) has been very commonly observed. Mean change among patients who had this increase was 41.7 mg/dL (≥1.07 mmol/L).
13. See text below.
14. Platelets ≤100 x 109/L on at least one occasion.
15. Based on clinical trial adverse event reports of blood creatine phosphokinase increase not associated with neuroleptic malignant syndrome.
16. Prolactin levels (patients >18 years of age): >20 μg/L (>869.56 pmol/L) males;
    >30 μg/L (>1304.34 pmol/L) females at any time.
17. May lead to falls.
18. HDL cholesterol: <40 mg/dL (1.025 mmol/L) males; <50 mg/dL (1.282 mmol/L) females at any time.
19. Incidence of patients who have a QTc shift from <450 msec to ≥450 msec with a ≥30 msec increase. In placebo-controlled trials with quetiapine the mean change and the incidence of patients who have a shift to a clinically significant level is similar between quetiapine and placebo.