Study: NCT00602355

Adverse event: Suicidal ideations or thoughts of self-harm
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 53 at risk

Adverse event: Infant hospitalized - bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Worsening of neurovegetative symptoms
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 53 at risk

Adverse event: Participant hospitalized - chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Infant hospitalized - croup cough
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Infant hospitalized - urinary infection and hand, foot, and mouth infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Infant hospitalized - high fever
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Participant reported experiencing headaches
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Participant reported experiencing insomnia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 53 at risk

Adverse event: Participant reported experiencing decreased libido
Serious: no
Organ System: General disorders
Frequency: 7 affected / 53 at risk

Adverse event: Patient reported experiencing severe fatigue/sleepiness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Worsening of symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: Worsening of depressive or other psychiatric symptoms
Frequency: 5 affected / 53 at risk

Adverse event: Participant reported experiencing severe agitation
Serious: no
Organ System: General disorders
Frequency: 2 affected / 53 at risk

Adverse event: Participant reported increased conflict with spouse or partner
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 53 at risk

Adverse event: Patient reported experiencing delayed orgasm
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 53 at risk

Adverse event: Patient reported mild loss of appetite
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Participant ER visit - sprained ankle
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 53 at risk

Adverse event: Participant reported ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Participant reported experiencing toothaches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Participant had 3 wisdom teeth removed
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 53 at risk

Adverse event: Infant experiencing "mild" excessive drowsiness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Participant reported that infant did not sleep (due to congestion) and is irritable
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Participant experienced rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 53 at risk

Adverse event: Participant reported severe nervousness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Participant experienced sinus infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Participant ER visit - shortness of breath, deemed likely to be anxiety related
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 53 at risk

Adverse event: Suicidal ideations or thoughts of self-harm
Serious: yes
Organ System: Psychiatric disorders
Frequency: 2 affected / 56 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 56 at risk

Adverse event: Infant hospitalized - bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Participant hospitalized - gall bladder removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 2 affected / 56 at risk

Adverse event: Infant hospitalized - dehydration, fever, vomiting (viral infection)
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Infant hospitalized - RSV
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 56 at risk

Adverse event: Participant hospitalized - kidney stone removal
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 56 at risk

Adverse event: Infant hospitalized - scheduled surgery for hydrocephalus
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 56 at risk

Adverse event: Participant reported experiencing headaches
Serious: no
Organ System: General disorders
Frequency: 4 affected / 56 at risk

Adverse event: Participant reported experiencing insomnia
Serious: no
Organ System: General disorders
Frequency: 5 affected / 56 at risk

Adverse event: Participant reported experiencing decreased libido
Serious: no
Organ System: General disorders
Frequency: 2 affected / 56 at risk

Adverse event: Patient reported experiencing severe fatigue/sleepiness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 56 at risk

Adverse event: Worsening of symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: Worsening of depressive or other psychiatric symptoms
Frequency: 3 affected / 56 at risk

Adverse event: Participant reported experiencing severe agitation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Patient reported experiencing delayed orgasm
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 56 at risk

Adverse event: Patient reported hair loss
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Participant contracted ringworm from daughter
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Participant screened positive on pregnancy test
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 56 at risk

Adverse event: Participant reported experiencing dizziness/vertigo
Serious: no
Organ System: General disorders
Frequency: 2 affected / 56 at risk

Adverse event: Participant had outpatient surgery on an existing hernia
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 56 at risk

Adverse event: Participant ER visit - experiencing abdominal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Participant reported experiencing itching and palpitations
Serious: no
Organ System: General disorders
Notes: resolved 1-2 days after stopping medication
Frequency: 1 affected / 56 at risk

Adverse event: Infant increased crying/fussiness, poor sleep, eating less, less frequent stool, less muscle tone
Serious: no
Organ System: General disorders
Notes: resolved when mother stopped breastfeeding for a day and discontinued use of study medication
Frequency: 1 affected / 56 at risk

Adverse event: Participant experienced pain due to having an IUD placed
Serious: no
Organ System: General disorders
Frequency: 1 affected / 56 at risk

Adverse event: Participant ER visit - sinusitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 56 at risk

Adverse event: Infant hospitalized - bronchiolitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 53 at risk

Adverse event: Participant hospitalized - kidney infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Participant hospitalized - bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 53 at risk

Adverse event: Participant hospitalized - hernia surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 53 at risk

Adverse event: Participant hospitalized - dehydration from excessive vomiting
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 53 at risk

Adverse event: Participant hospitalized - hyperemesis gravidarum
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 53 at risk

Adverse event: Infant hospitalized - reaction to Enfamil
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Participant reported experiencing headaches
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Participant reported experiencing insomnia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Patient reported experiencing severe fatigue/sleepiness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 53 at risk

Adverse event: Worsening of symptoms
Serious: no
Organ System: Psychiatric disorders
Notes: Worsening of depressive or other psychiatric symptoms
Frequency: 4 affected / 53 at risk

Adverse event: Participant reported experiencing severe agitation
Serious: no
Organ System: General disorders
Frequency: 3 affected / 53 at risk

Adverse event: Participant reported increased conflict with spouse or partner
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 53 at risk

Adverse event: Participant reported fainting
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Infant had fever and diarrhea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Participant injured eye while playing paintball - consulted doctor and healing well
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 53 at risk

Adverse event: Participant experienced kidney infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 53 at risk

Adverse event: Increased conflict with other family and friends
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 53 at risk

Adverse event: Infant experienced increased colic
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk

Adverse event: Separation from spouse
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 53 at risk

Adverse event: Participant diagnosed with 2 bulging discs causing back and leg pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 53 at risk