Study: NCT02543944

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Abdominal pain/soreness
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 60 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Urination changes
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 60 at risk

Adverse event: Bright colored urine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Sedation/drowsiness
Serious: no
Organ System: General disorders
Frequency: 8 affected / 60 at risk

Adverse event: Listlessness/loss of energy
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Sleep disturbance/sleep walking
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Muscle twitches/tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 60 at risk

Adverse event: Tingling extremities
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 60 at risk

Adverse event: Muscle/skeletal pain/discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 60 at risk

Adverse event: Fall
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 7 affected / 60 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 3 affected / 60 at risk

Adverse event: Burning sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Blood shot eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 60 at risk

Adverse event: Changes in vision
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 60 at risk

Adverse event: Changes in taste
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 60 at risk

Adverse event: Bruising/laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 60 at risk

Adverse event: Respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Hiccups
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Elevated heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 60 at risk

Adverse event: Edema/swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Flu virus
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk

Adverse event: Sexual side effect
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Hallucinations, mixed
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Confusion/Disorientation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Agitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Anger
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Symptoms of anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Dysphoria
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Symptoms of depression and/or anhedonia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal symptoms
Serious: no
Organ System: General disorders
Frequency: 13 affected / 60 at risk

Adverse event: Withdrawal symptoms: not specified
Serious: no
Organ System: General disorders
Frequency: 3 affected / 60 at risk

Adverse event: Withdrawal sx: Muscle cramps
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal sx: Bone/muscle pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Withdrawal sx: Stomach cramps
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Withdrawal sx: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Withdrawal sx: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Withdrawal sx: Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Withdrawal sx: Runny nose/sneezing and/or watery eyes
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal sx: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal sx: Excessive sweating
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Withdrawal sx: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Withdrawal sx: Restlessness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal sx: Yawning
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal sx: Stretching
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal sx: Shakes/tremors
Serious: no
Organ System: General disorders
Frequency: 2 affected / 60 at risk

Adverse event: Withdrawal sx: Tingling extremities
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal sx: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal sx: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal sx: Depression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal sx: Anxiety
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Withdrawal sx: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 57 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Loose, pale stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 57 at risk

Adverse event: Urination changes
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 57 at risk

Adverse event: Sedation/drowsiness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 57 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Muscle twitches/tremors
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 57 at risk

Adverse event: Muscle/skeletal pain/discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Changes in equilibrium
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 57 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Dry eye
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 57 at risk

Adverse event: Changes in taste
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 57 at risk

Adverse event: Rash on knees
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 57 at risk

Adverse event: Diagnosis of shingles
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 57 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 57 at risk

Adverse event: Bruising/laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 57 at risk

Adverse event: Respiratory symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 57 at risk

Adverse event: Elevated heart rate
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 57 at risk

Adverse event: Edema/swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Hot/cold sweats
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Continuously hot all day
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Symptoms of anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 57 at risk

Adverse event: Symptoms of depression and/or anhedonia
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 57 at risk

Adverse event: Suicidal ideation
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal symptoms
Serious: no
Organ System: General disorders
Frequency: 19 affected / 57 at risk

Adverse event: Withdrawal symptoms: not specified
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Related to dehydration
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Leg pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Withdrawal sx: Muscle cramps
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Bone/muscle pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Withdrawal sx: Stomach cramps
Serious: no
Organ System: General disorders
Frequency: 9 affected / 57 at risk

Adverse event: Withdrawal sx: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 57 at risk

Adverse event: Withdrawal sx: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 57 at risk

Adverse event: Withdrawal sx: Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 57 at risk

Adverse event: Withdrawal sx: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Runny nose/sneezing and/or watery eyes
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Withdrawal sx: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Hot/cold sweats
Serious: no
Organ System: General disorders
Frequency: 5 affected / 57 at risk

Adverse event: Withdrawal sx: Excessive sweating
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Withdrawal sx: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Sedation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Withdrawal sx: Insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Withdrawal sx: Restlessness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 57 at risk

Adverse event: Withdrawal sx: Yawning
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Withdrawal sx: Muscle twiches/jerks
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Shakes/tremors
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Headache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Lightheaded
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Short of breath
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Clammy feet/hands
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Gooseflesh
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Depression
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk

Adverse event: Withdrawal sx: Anxiety
Serious: no
Organ System: General disorders
Frequency: 2 affected / 57 at risk

Adverse event: Withdrawal sx: Irritability
Serious: no
Organ System: General disorders
Frequency: 1 affected / 57 at risk