Study: NCT00001723

Adverse event: ear disorders (otitis, earache, ear pain)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 100 at risk

Adverse event: eye disorders (change in vision, conjunctivitis, styes)
Serious: no
Organ System: Eye disorders
Frequency: 8 affected / 100 at risk

Adverse event: abdominal pain or cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 100 at risk

Adverse event: bloating or gas
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 100 at risk

Adverse event: Gastrointestinal sounds abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 100 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Controlled discharge of oil without stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 100 at risk

Adverse event: Decreased frequency of bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 25 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 100 at risk

Adverse event: fatty-appearing stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 100 at risk

Adverse event: flatulence (passage of gas)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 100 at risk

Adverse event: flatus with discharge
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 43 affected / 100 at risk

Adverse event: frequent urge for bowel movement
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 100 at risk

Adverse event: Hiccups
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Increased frequency of bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 100 at risk

Adverse event: oily spotting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 100 at risk

Adverse event: rectal bleeding - hemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 100 at risk

Adverse event: soft or deliquescent stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 68 affected / 100 at risk

Adverse event: stomach pain or cramps
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 100 at risk

Adverse event: Stools almost all liquid with very few solid parts
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 64 affected / 100 at risk

Adverse event: Stools hard and in the shape of small pellets
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 100 at risk

Adverse event: Stools mixed with fat or with a separate oily layer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 83 affected / 100 at risk

Adverse event: uncontrolled passage of stool or oil
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 60 affected / 100 at risk

Adverse event: Urgent, but controlled, need to produce stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 100 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 14 affected / 100 at risk

Adverse event: increased sweating
Serious: no
Organ System: General disorders
Frequency: 3 affected / 100 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: sinusitis, post-nasal drip or nasal stuffiness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 100 at risk

Adverse event: unusual tiredness or weakness (fatigue)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 100 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 100 at risk

Adverse event: sinusitis, post-nasal drip or nasal stuffiness
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 100 at risk

Adverse event: decrease in appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 11 affected / 100 at risk

Adverse event: muscle pain, stiffness, cramps, or ache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 16 affected / 100 at risk

Adverse event: migraine headaches
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 100 at risk

Adverse event: mental depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 100 at risk

Adverse event: dysuria or UTI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 100 at risk

Adverse event: Asthma symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 100 at risk

Adverse event: Hypoglycemia - pharmacy error in preparing insulin
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 100 at risk

Adverse event: Left lower quadrant pain and vomiting - admitted overnight
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: ear disorders (otitis, earache, ear pain)
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 7 affected / 100 at risk

Adverse event: eye disorders (change in vision, conjunctivitis, styes)
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 100 at risk

Adverse event: abdominal pain or cramping
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 100 at risk

Adverse event: bloating or gas
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Gastrointestinal sounds abnormal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 100 at risk

Adverse event: Controlled discharge of oil without stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 100 at risk

Adverse event: Decreased frequency of bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 22 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 100 at risk

Adverse event: fatty-appearing stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 100 at risk

Adverse event: flatulence (passage of gas)
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 47 affected / 100 at risk

Adverse event: flatus with discharge
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 100 at risk

Adverse event: frequent urge for bowel movement
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Hiccups
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Increased frequency of bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 45 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 100 at risk

Adverse event: rectal bleeding - hemorrhoids
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 100 at risk

Adverse event: soft or deliquescent stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 42 affected / 100 at risk

Adverse event: stomach pain or cramps
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 100 at risk

Adverse event: Stools almost all liquid with very few solid parts
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 34 affected / 100 at risk

Adverse event: Stools hard and in the shape of small pellets
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 100 at risk

Adverse event: Stools mixed with fat or with a separate oily layer
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 100 at risk

Adverse event: uncontrolled passage of stool or oil
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 100 at risk

Adverse event: Urgent, but controlled, need to produce stools
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 100 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: Epistaxis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 100 at risk

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 2 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 17 affected / 100 at risk

Adverse event: increased sweating
Serious: no
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: Thirst
Serious: no
Organ System: General disorders
Frequency: 4 affected / 100 at risk

Adverse event: sinusitis, post-nasal drip or nasal stuffiness
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: unusual tiredness or weakness (fatigue)
Serious: no
Organ System: General disorders
Frequency: 5 affected / 100 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 12 affected / 100 at risk

Adverse event: sinusitis, post-nasal drip or nasal stuffiness
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 100 at risk

Adverse event: decrease in appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 100 at risk

Adverse event: muscle pain, stiffness, cramps, or ache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 12 affected / 100 at risk

Adverse event: mental depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 100 at risk

Adverse event: dysuria or UTI
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 100 at risk

Adverse event: Nocturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 3 affected / 100 at risk

Adverse event: Asthma symptoms
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 100 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 100 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 100 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 100 at risk