ers
Somnolence†
13%
52%
Extrapyramidal Symptoms‡
1%
4%
Dizziness
11%
13%
Paraesthesia
2%
3%
Disturbance in Attention
1%
2%
Dysarthria
0%
2%
Akathisia
0%
2%
Hypersomnia
0%
2%
Mental Impairment
0%
2%
Migraine
1%
2%
Restless Legs Syndrome
1%
2%
Sinus Headache
1%
2%
Psychiatric Disorders
Abnormal Dreams
0%
3%
Anxiety
1%
2%
Confusional State
0%
2%
Disorientation
0%
2%
Libido Decreased
1%
2%
Renal And Urinary Disorders
Pollakiuria
1%
2%
Respiratory, Thoracic And Mediastinal Disorders
Sinus Congestion
1%
2%
Skin And Subcutaneous Tissue Disorders
Hyperhidrosis
1%
2%
Vascular Disorders
Orthostatic Hypotension
1%
2%
In the 6-week placebo-controlled fixed dose adjunctive therapy clinical trials, for MDD, the most commonly observed adverse reactions associated with the use of SEROQUEL XR (incidence of 5% or greater and observed at a rate on SEROQUEL XR and at least twice that of placebo) were somnolence (150 mg: 37%; 300 mg: 43%), dry mouth (150 mg: 27%; 300 mg: 40%), fatigue (150 mg: 14%; 300 mg: 11%) and constipation (150 mg only: 11%).
Table 13 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during short-term adjunctive therapy of MDD (up to 6 weeks) in 1% or more of patients treated with SEROQUEL XR (at doses of either 150 mg or 300 mg/day) where the incidence in patients treated with SEROQUEL XR was greater than the incidence in placebo-treated patients.
Table 13: Treatment-Emergent Adverse Reaction Incidence in Placebo-Controlled Adjunctive Therapy Clinical Trials for the Treatment of MDD by Fixed Dose * Table 13
Body System/Preferred Term Placebo
(n=309) SEROQUEL XR 150 mg
(n=315) SEROQUEL XR 300 mg
(n=312)
*
1Reactions for which the SEROQUEL XR incidence was 1% or more but equal to or less than placebo are not listed in the table, but included the following: headache, insomnia, nausea, disturbance in attention, dysarthria, paraesthesia, tremor, diarrhea, upper abdominal pain, nightmare, nasopharyngitis, sinusitis, decreased appetite, myalgia, arthralgia, pain in extremity, hyperhidrosis, night sweats and nasal congestion.
†
Somnolence combines adverse event terms somnolence and sedation.
‡
3Extrapyramidal symptoms that were reported for SEROQUEL XR or placebo include the terms: akathisia, cogwheel rigidity, drooling, dyskinesia, extrapyramidal disorder, hypertonia, hypokinesia, psychomotor hyperactivity, restlessness, and tremor.
Ear And Labyrinth Disorders
Vertigo
1%
2%
2%
Eye Disorders
Vision Blurred
1%
