Study: NCT01832480

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 61 affected / 311 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 311 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 311 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 18 affected / 311 at risk

Adverse event: Bad taste in mouth
Serious: no
Organ System: General disorders
Frequency: 6 affected / 311 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 311 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 311 at risk

Adverse event: Yeast infections
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 311 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 311 at risk

Adverse event: Verbal intimidation by partner
Serious: no
Organ System: General disorders
Frequency: 1 affected / 311 at risk

Adverse event: Vision change
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 311 at risk

Adverse event: Persistent nausea/vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: This was recorded as a single adverse event
Frequency: 1 affected / 311 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 311 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 311 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 311 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Notes: Not clinically assessed, described as feeling low
Frequency: 1 affected / 311 at risk

Adverse event: Hot flush
Serious: no
Organ System: General disorders
Frequency: 1 affected / 311 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 311 at risk

Adverse event: Myalagia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 311 at risk

Adverse event: Altered mental state
Serious: no
Organ System: General disorders
Frequency: 1 affected / 311 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: women tested negative for pregnancy at baseline but were found to be pregnant at follow-up and had a spontaneous abortion that may or may not have been a results of the medication
Frequency: 2 affected / 312 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 63 affected / 312 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 24 affected / 312 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 312 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 16 affected / 312 at risk

Adverse event: Bad taste in mouth
Serious: no
Organ System: General disorders
Frequency: 4 affected / 312 at risk

Adverse event: Vulvovaginal pruritus
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 312 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 312 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 312 at risk

Adverse event: Yeast infections
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 2 affected / 312 at risk

Adverse event: Verbal intimidation by partner
Serious: no
Organ System: General disorders
Frequency: 1 affected / 312 at risk

Adverse event: Increased bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 312 at risk

Adverse event: Hypoaesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 312 at risk

Adverse event: Restlessness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 312 at risk

Adverse event: Depression
Serious: no
Organ System: General disorders
Notes: Not clinically assessed, described as feeling low
Frequency: 1 affected / 312 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 312 at risk

Adverse event: General feeling sick
Serious: no
Organ System: General disorders
Frequency: 1 affected / 312 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 312 at risk

Adverse event: Chromaturia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 312 at risk

Adverse event: Peeling skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 312 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 312 at risk