Study: NCT00251303

Adverse event: Pancreatitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 30 at risk

Adverse event: chest pain, hypotension, Tachycardia, EKG abnormality, and other cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 8 affected / 30 at risk

Adverse event: earache, poor hearing, Tinnitus, and ear other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 13 affected / 30 at risk

Adverse event: eye irritation, blurred vision, eye other
Serious: no
Organ System: Eye disorders
Frequency: 6 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 30 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 4 affected / 30 at risk

Adverse event: Muscle Bone joint pain, Dyskinesia, Muscle Rigidity, and Musclualrsketetal other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 14 affected / 30 at risk

Adverse event: Mouth Ulcer, Dry mouth, sore tongue, gum problems, Dental problems, and mouth other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 30 at risk

Adverse event: Stomach or abdominal discomfort, nausea, vomitting, diarrhea, constipation, stool discoloration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 30 at risk

Adverse event: appetite increase/decrease, taste abnormality, increased thirst, and gastrointestinal other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 30 at risk

Adverse event: headache, dizziness, akathisia, tremor, tic movements, slurred speech, and confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 23 affected / 30 at risk

Adverse event: concentration difficulty and memory problems
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 30 at risk

Adverse event: Painful urination, difficulty urinating, increased frequency, and enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 30 at risk

Adverse event: Dermatologic Skin Irritation, Sweating, hair problems, and skin other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 30 at risk

Adverse event: breast pain swelling, discharge from nipples, menstrual irregularity, cramps, premenstral tension
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 7 affected / 8 at risk

Adverse event: genital discomfort, increased/decreased libido and genitourinary other
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 5 affected / 30 at risk

Adverse event: nasal congestion, bloody nose, sore throat, difficulty swallowing, and flu upper respitory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 30 at risk

Adverse event: nose throat other, shortness of breath, wheezing, and coughing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 30 at risk

Adverse event: medical or surgical procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 30 at risk

Adverse event: tiredness fatigue, increased/decreased motor activity, difficulty falling asleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 30 at risk

Adverse event: early morning awakening, interrupted sleep, drowsiness sedation, hallucinations, depression, anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 24 affected / 30 at risk

Adverse event: irritability, suicidal ideas, suicidal behavior, agression, and psychological behavior other
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 30 at risk

Adverse event: Swelling
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 30 at risk

Adverse event: chest pain, hypotension, Tachycardia, EKG abnormality, and other cardiovascular
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 30 at risk

Adverse event: earache, poor hearing, Tinnitus, and ear other
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 11 affected / 30 at risk

Adverse event: eye irritation, blurred vision, eye other
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 30 at risk

Adverse event: Pyrexia
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 30 at risk

Adverse event: Injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 30 at risk

Adverse event: Muscle Bone joint pain, Dyskinesia, Muscle Rigidity, and Musclualrsketetal other
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 30 at risk

Adverse event: Mouth Ulcer, Dry mouth, sore tongue, gum problems, Dental problems, and mouth other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 30 at risk

Adverse event: Stomach or abdominal discomfort, nausea, vomitting, diarrhea, constipation, stool discoloration
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 30 at risk

Adverse event: appetite increase/decrease, taste abnormality, increased thirst, and gastrointestinal other
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 30 at risk

Adverse event: headache, dizziness, akathisia, tremor, tic movements, slurred speech, and confusion
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 30 at risk

Adverse event: concentration difficulty and memory problems
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 30 at risk

Adverse event: Painful urination, difficulty urinating, increased frequency, and enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 13 affected / 30 at risk

Adverse event: Dermatologic Skin Irritation, Sweating, hair problems, and skin other
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 20 affected / 30 at risk

Adverse event: breast pain swelling, discharge from nipples, menstrual irregularity, cramps, premenstral tension
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 4 affected / 8 at risk

Adverse event: genital discomfort, increased/decreased libido and genitourinary other
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 30 at risk

Adverse event: nasal congestion, bloody nose, sore throat, difficulty swallowing, and flu upper respitory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 24 affected / 30 at risk

Adverse event: nose throat other, shortness of breath, wheezing, and coughing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 30 at risk

Adverse event: medical or surgical procedure
Serious: no
Organ System: Surgical and medical procedures
Frequency: 3 affected / 30 at risk

Adverse event: tiredness fatigue, increased/decreased motor activity, difficulty falling asleep
Serious: no
Organ System: Psychiatric disorders
Frequency: 22 affected / 30 at risk

Adverse event: early morning awakening, interrupted sleep, drowsiness sedation, hallucinations, depression, anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 25 affected / 30 at risk

Adverse event: irritability, suicidal ideas, suicidal behavior, agression, and psychological behavior other
Serious: no
Organ System: Psychiatric disorders
Frequency: 21 affected / 30 at risk