Study: NCT01429454

Adverse event: Hospitalization due to suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 62 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Notes: Overdose of pills
Frequency: 1 affected / 62 at risk

Adverse event: Attempt to quiet auditory hallucinations
Serious: yes
Organ System: Psychiatric disorders
Notes: With excess Quetiapine ingestion
Frequency: 1 affected / 62 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Notes: Evaluated at the Emergency Department
Frequency: 1 affected / 62 at risk

Adverse event: Sedation/drowsiness
Serious: no
Organ System: Nervous system disorders
Frequency: 28 affected / 62 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 36 affected / 62 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 32 affected / 62 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 26 affected / 62 at risk

Adverse event: Sleep disturbance, other
Serious: no
Organ System: General disorders
Frequency: 26 affected / 62 at risk

Adverse event: Fatigue/weakness
Serious: no
Organ System: General disorders
Frequency: 27 affected / 62 at risk

Adverse event: Excitement/nervousness
Serious: no
Organ System: General disorders
Frequency: 26 affected / 62 at risk

Adverse event: Appetite decrease
Serious: no
Organ System: General disorders
Frequency: 25 affected / 62 at risk

Adverse event: Memory problems
Serious: no
Organ System: General disorders
Frequency: 25 affected / 62 at risk

Adverse event: Sensory perception abnormality
Serious: no
Organ System: General disorders
Frequency: 24 affected / 62 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 21 affected / 62 at risk

Adverse event: Stomach/abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 62 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 23 affected / 62 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 19 affected / 62 at risk

Adverse event: Mental impairment
Serious: no
Organ System: General disorders
Frequency: 19 affected / 62 at risk

Adverse event: Dizziness/faintness
Serious: no
Organ System: General disorders
Frequency: 14 affected / 62 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 62 at risk

Adverse event: Appetite increase
Serious: no
Organ System: General disorders
Frequency: 19 affected / 62 at risk

Adverse event: Weight increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 62 at risk

Adverse event: Tinnitus/difficulty hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 19 affected / 62 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 15 affected / 62 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 62 at risk

Adverse event: Muscle twitching
Serious: no
Organ System: General disorders
Frequency: 18 affected / 62 at risk

Adverse event: Depersonalisation/derealisation disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 62 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: General disorders
Frequency: 14 affected / 62 at risk

Adverse event: Tachycardia/palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 62 at risk

Adverse event: Derealisation
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 62 at risk

Adverse event: Ataxia/impaired coordination
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 13 affected / 62 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 12 affected / 62 at risk

Adverse event: Delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 13 affected / 62 at risk

Adverse event: Sweating excessively
Serious: no
Organ System: General disorders
Frequency: 10 affected / 62 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 62 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 15 affected / 62 at risk

Adverse event: Dysarthria
Serious: no
Organ System: General disorders
Frequency: 14 affected / 62 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 62 at risk

Adverse event: Dermatitis/allergy
Serious: no
Organ System: General disorders
Frequency: 14 affected / 62 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Libido decrease
Serious: no
Organ System: General disorders
Frequency: 8 affected / 62 at risk

Adverse event: Salivation increase
Serious: no
Organ System: General disorders
Frequency: 7 affected / 62 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 62 at risk

Adverse event: Abnormal muscle tone/movement
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 62 at risk

Adverse event: Hyperventilation
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Libido increase
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 5 affected / 62 at risk

Adverse event: Fishy burp
Serious: no
Organ System: General disorders
Frequency: 6 affected / 62 at risk

Adverse event: Hospitalization due to suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 65 at risk

Adverse event: Hospitalization due to severe stomach pain diagnosed as Crohn's disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 65 at risk

Adverse event: Sedation/drowsiness
Serious: no
Organ System: Nervous system disorders
Frequency: 36 affected / 65 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 33 affected / 65 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 31 affected / 65 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 35 affected / 65 at risk

Adverse event: Sleep disturbance, other
Serious: no
Organ System: General disorders
Frequency: 35 affected / 65 at risk

Adverse event: Fatigue/weakness
Serious: no
Organ System: General disorders
Frequency: 31 affected / 65 at risk

Adverse event: Excitement/nervousness
Serious: no
Organ System: General disorders
Frequency: 29 affected / 65 at risk

Adverse event: Appetite decrease
Serious: no
Organ System: General disorders
Frequency: 28 affected / 65 at risk

Adverse event: Memory problems
Serious: no
Organ System: General disorders
Frequency: 25 affected / 65 at risk

Adverse event: Sensory perception abnormality
Serious: no
Organ System: General disorders
Frequency: 26 affected / 65 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Frequency: 25 affected / 65 at risk

Adverse event: Stomach/abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 24 affected / 65 at risk

Adverse event: Hallucination
Serious: no
Organ System: Psychiatric disorders
Frequency: 20 affected / 65 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: General disorders
Frequency: 24 affected / 65 at risk

Adverse event: Mental impairment
Serious: no
Organ System: General disorders
Frequency: 21 affected / 65 at risk

Adverse event: Dizziness/faintness
Serious: no
Organ System: General disorders
Frequency: 24 affected / 65 at risk

Adverse event: Nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 65 at risk

Adverse event: Appetite increase
Serious: no
Organ System: General disorders
Frequency: 19 affected / 65 at risk

Adverse event: Weight increased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 65 at risk

Adverse event: Tinnitus/difficulty hearing
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 17 affected / 65 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 21 affected / 65 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 65 at risk

Adverse event: Muscle twitching
Serious: no
Organ System: General disorders
Frequency: 15 affected / 65 at risk

Adverse event: Depersonalisation/derealisation disorder
Serious: no
Organ System: Psychiatric disorders
Frequency: 16 affected / 65 at risk

Adverse event: Muscle spasms
Serious: no
Organ System: General disorders
Frequency: 18 affected / 65 at risk

Adverse event: Tachycardia/palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 15 affected / 65 at risk

Adverse event: Derealisation
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 65 at risk

Adverse event: Ataxia/impaired coordination
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 17 affected / 65 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 17 affected / 65 at risk

Adverse event: Delusion
Serious: no
Organ System: Psychiatric disorders
Frequency: 15 affected / 65 at risk

Adverse event: Sweating excessively
Serious: no
Organ System: General disorders
Frequency: 17 affected / 65 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 65 at risk

Adverse event: Tremor
Serious: no
Organ System: General disorders
Frequency: 11 affected / 65 at risk

Adverse event: Dysarthria
Serious: no
Organ System: General disorders
Frequency: 10 affected / 65 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 65 at risk

Adverse event: Dermatitis/allergy
Serious: no
Organ System: General disorders
Frequency: 10 affected / 65 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 17 affected / 65 at risk

Adverse event: Libido decrease
Serious: no
Organ System: General disorders
Frequency: 11 affected / 65 at risk

Adverse event: Salivation increase
Serious: no
Organ System: General disorders
Frequency: 10 affected / 65 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 65 at risk

Adverse event: Abnormal muscle tone/movement
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 8 affected / 65 at risk

Adverse event: Hyperventilation
Serious: no
Organ System: General disorders
Frequency: 8 affected / 65 at risk

Adverse event: Libido increase
Serious: no
Organ System: General disorders
Frequency: 8 affected / 65 at risk

Adverse event: Oedema
Serious: no
Organ System: General disorders
Frequency: 4 affected / 65 at risk

Adverse event: Urination problems
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 65 at risk

Adverse event: Fishy burp
Serious: no
Organ System: General disorders
Frequency: 10 affected / 65 at risk