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Index of reports
> Cases with Foetal Exposure During Pregnancy (97)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Suboxone (Buprenorphine / Naloxone) where reactions include foetal exposure during pregnancy. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 97 Next >>
Possible Suboxone side effects in
Reported by a physician from United States on 2012-08-24
Patient:
Reactions: Foetal Growth Restriction, LOW Birth Weight Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Suboxone
Possible Suboxone side effects in
Reported by a physician from United States on 2012-08-23
Patient:
Reactions: Premature Baby, Foetal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lorazepam
Dosage: dosing details unknown
Indication: Product Used FOR Unknown Indication
Benzodiazepines
Dosage: dosing details unknown
Indication: Product Used FOR Unknown Indication
Amphetamines
Dosage: dosing details unknown
Indication: Product Used FOR Unknown Indication
Cocaine
Indication: Product Used FOR Unknown Indication
Nifedipine
Dosage: dosing details unknown
Indication: Premature Labour
Methylphenidate
Dosage: dosing details unknown
Indication: Product Used FOR Unknown Indication
Subutex
Dosage: dosing details unknown
Indication: Drug Dependence
Terbutaline
Indication: Premature Labour
Hydroxyzine
Dosage: dosing details unknown
Indication: Product Used FOR Unknown Indication
Seroquel
Dosage: unknown dosing details
Indication: Product Used FOR Unknown Indication
Suboxone
Dosage: dosing details unknown
Indication: Drug Dependence
Barbiturates
Dosage: dosing details unknown
Indication: Product Used FOR Unknown Indication
Possible Suboxone side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: female
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Suboxone
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-15
Patient: male
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Suboxone
Possible Suboxone side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-09
Patient:
Reactions: Foetal Exposure During Pregnancy, Ventricular Septal Defect
Drug(s) suspected as cause:
Suboxone
Dosage: 10 mg, unk
Indication: Drug Dependence
Start date: 2009-06-01
End date: 2010-10-08
Valtrex
Dosage: 1 g, unk
Indication: Herpes Virus Infection
Start date: 2011-04-19
Ribavirin (+) Interferon Alfa-2B
Dosage: unk
Start date: 2009-01-01
End date: 2010-06-04
PEG-Intron
Dosage: unk
Start date: 2009-01-01
End date: 2010-06-04
Proventil
Dosage: unk, prn
Indication: Asthma
Effexor
Dosage: 75 mg, unk
Indication: Depression
Start date: 2007-01-01
End date: 2010-11-30
Zoloft
Dosage: 50 mg, unk
Indication: Depression
Start date: 2010-11-30
Subutex
Dosage: 8 mg, unk
Indication: Drug Dependence
Start date: 2010-10-09
Other drugs received by patient: Vitamins (Unspecified)
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-09
Patient: male
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Suboxone
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: male, weighing 2.5 kg (5.5 pounds)
Reactions: LOW Birth Weight Baby, Exposure During Breast Feeding, Premature Baby, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Suboxone
Indication: Drug Dependence
Start date: 2011-01-01
Nicotine
Dosage: 1/2 pack per day
Start date: 2011-09-20
End date: 2011-09-22
Nicotine
Dosage: 1/2 pack daily
Indication: Nicotine Dependence
End date: 2011-09-20
Buprenorphine
Indication: Drug Dependence
End date: 2011-09-20
Buprenorphine
Start date: 2011-09-20
End date: 2011-09-22
Multi-Vitamins
Dosage: one daily
Indication: Pregnancy
End date: 2011-09-20
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-26
Patient: male
Reactions: Speech Disorder Developmental, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Stool Softeners
Dosage: dosing details unknown
Indication: Constipation
Start date: 2008-01-01
End date: 2009-05-27
Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP
Dosage: dosing details unknown
Indication: Pregnancy
Start date: 2008-01-01
End date: 2009-05-27
Nausea Medication
Dosage: dosing details unknown
Indication: Nausea
Start date: 2008-01-01
End date: 2009-05-27
Subutex
Dosage: various doses from 4 mg to 20 mg daily
Indication: Drug Dependence
Start date: 2008-09-01
End date: 2009-05-27
Nicotine
Dosage: 2 cigarettes per day
Indication: Nicotine Dependence
Start date: 2008-09-01
End date: 2009-05-27
Suboxone
Dosage: 16-24 mg daily
Indication: Drug Dependence
Start date: 2008-09-01
End date: 2008-09-01
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-25
Patient: male
Reactions: Maternal Drugs Affecting Foetus, Neonatal Respiratory Distress Syndrome, Foetal Exposure During Pregnancy, Neonatal Tachycardia, Neonatal Tachypnoea, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Suboxone
Indication: Drug Dependence
Start date: 2011-03-01
End date: 2011-06-01
Buprenorphine
Indication: Drug Dependence
Start date: 2011-06-01
End date: 2011-01-01
Buprenorphine
Start date: 2011-01-01
End date: 2011-11-26
Possible Suboxone side effects in
Reported by a physician from United States on 2012-06-22
Patient:
Reactions: Premature Baby, Foetal Exposure During Pregnancy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Suboxone
Possible Suboxone side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-22
Patient: female
Reactions: LOW Birth Weight Baby, Lung Disorder, Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Suboxone
Dosage: dosing details unknown
Indication: Drug Dependence
End date: 2012-06-17
Nicotine
Dosage: one pack per day
Indication: Nicotine Dependence
End date: 2012-06-17
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: male, weighing 4.0 kg (8.8 pounds)
Reactions: Blood Glucose Decreased, Contusion, Exposure During Breast Feeding, Foetal Exposure During Pregnancy, Large FOR Dates Baby, Jaundice Neonatal, Dermatitis Diaper
Drug(s) suspected as cause:
Suboxone
Indication: Drug Dependence
Start date: 2011-05-01
End date: 2011-07-01
Opiates
Dosage: unknown dosage details
Indication: Pain
Start date: 2012-02-15
End date: 2012-02-24
Buprenorphine
Dosage: 6 mg daily
Indication: Drug Dependence
Start date: 2012-02-25
End date: 2012-01-01
Buprenorphine
Dosage: various doses daily
Start date: 2011-07-01
End date: 2012-02-13
Buprenorphine
Dosage: 10 mg daily
Start date: 2012-01-01
Possible Suboxone side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: female, weighing 4.0 kg (8.8 pounds)
Reactions: Vomiting, Galactosaemia, Exposure During Breast Feeding, Diarrhoea, Foetal Exposure During Pregnancy, Convulsion Neonatal
Drug(s) suspected as cause:
Clonidine
Dosage: dosing details unknown
Indication: Drug Withdrawal Syndrome
Start date: 2011-06-01
End date: 2011-09-01
Subutex TAB Generic
Indication: Drug Dependence
Start date: 2011-12-01
End date: 2012-03-09
Subutex TAB Generic
Start date: 2012-03-09
End date: 2012-03-16
Suboxone
Indication: Drug Dependence
Start date: 2011-09-01
End date: 2011-12-01
Heroin
Dosage: dosing details unknown
Indication: Product Used FOR Unknown Indication
Start date: 2011-06-01
End date: 2011-09-01
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-14
Patient: male, weighing 3.8 kg (8.4 pounds)
Reactions: Meconium Stain, Exposure During Breast Feeding, Foetal Exposure During Pregnancy, Sneezing, Pyrexia, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Buprenorphine HCL
Dosage: varied tapered doses
Start date: 2012-04-01
End date: 2012-05-10
Buprenorphine HCL
Dosage: doses vary
Start date: 2012-05-12
Zofran
Dosage: unknown dosage details
Indication: Nausea
Start date: 2011-10-01
End date: 2012-03-01
Antibiotic
Dosage: unknown dosage details
Indication: Ear Infection
Start date: 2011-01-01
End date: 2011-01-01
Suboxone
Dosage: various tapered doses
Indication: Drug Dependence
Start date: 2011-09-19
End date: 2011-10-01
Vitamin and Mineral Prenatal Supplement W / Folic Acid CAP
Dosage: one daily
Indication: Pregnancy
Start date: 2011-10-01
End date: 2012-05-12
Buprenorphine HCL
Dosage: 8-16 mg daily
Indication: Drug Dependence
Start date: 2011-10-01
End date: 2012-04-01
Zofran
Dosage: unknown dosage details
Indication: Vomiting
Start date: 2011-10-01
End date: 2012-03-01
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-12
Patient: male
Reactions: Premature Baby, Exposure During Breast Feeding, Foetal Exposure During Pregnancy, Jaundice Neonatal
Drug(s) suspected as cause:
Suboxone
Indication: Drug Dependence
Start date: 2011-03-01
End date: 2011-08-01
Buprenorphine
Indication: Drug Dependence
Start date: 2011-08-01
End date: 2011-11-19
Methadone HCL
Dosage: unknown unit dose
Indication: Drug Dependence
Start date: 2011-08-01
End date: 2011-08-01
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: male
Reactions: Foetal Exposure During Pregnancy, Fever Neonatal, Sepsis Neonatal, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Suboxone
Dosage: 8 mg daily tapered to 2 mg daily at times
Indication: Drug Dependence
Start date: 2012-02-01
End date: 2012-04-30
Nicotine
Dosage: 2 packs daily tapered to 6 cigarettes daily
Indication: Nicotine Dependence
Start date: 2011-07-01
End date: 2012-04-30
Percocet
Dosage: dosing details unknown
Indication: Pain
Start date: 2011-07-01
End date: 2012-02-01
Possible Suboxone side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-08
Patient: male
Reactions: Foetal Exposure During Pregnancy, Jaundice Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ambien
Dosage: dosing details unknown
Indication: Insomnia
Subutex
Indication: Drug Dependence
Start date: 2011-09-22
End date: 2012-05-08
Suboxone
Indication: Drug Dependence
Start date: 2011-08-01
End date: 2011-09-21
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-06
Patient: male, weighing 3.2 kg (7.0 pounds)
Reactions: Cleft Palate, Foetal Exposure During Pregnancy, Feeding Disorder Neonatal
Drug(s) suspected as cause:
Suboxone
Dosage: 8 mg daily
Indication: Drug Dependence
Start date: 2011-03-01
End date: 2011-06-01
Nicotine
Dosage: dosing details not provided
Indication: Nicotine Dependence
Start date: 2011-03-01
End date: 2011-12-15
Buprenorphine
Dosage: 16 mg daily
Indication: Drug Dependence
Start date: 2011-06-01
End date: 2011-12-15
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-31
Patient: male, weighing 3.2 kg (7.0 pounds)
Reactions: Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Nicotine
Dosage: one pack/daily
Indication: Product Used FOR Unknown Indication
End date: 2011-01-19
Suboxone
Indication: Drug Dependence
End date: 2010-06-01
Suboxone
Dosage: various tapered doses
Start date: 2010-06-01
End date: 2010-11-01
Possible Suboxone side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: female
Reactions: Lactose Intolerance, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Suboxone
Dosage: dosing details unknown
Indication: Product Used FOR Unknown Indication
Start date: 2011-01-01
Subutex
Dosage: dosing details unknown
Indication: Product Used FOR Unknown Indication
Possible Suboxone side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-18
Patient: female
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Hypocalcaemia, Heart Disease Congenital, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Suboxone
Possible Suboxone side effects in male
Reported by a physician from United States on 2012-05-14
Patient: male
Reactions: Asperger's Disorder, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Suboxone
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-12
Patient: male
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Jaundice Neonatal
Drug(s) suspected as cause:
Subutex
Dosage: unknown dosage details
Indication: Product Used FOR Unknown Indication
Start date: 2011-01-01
Suboxone
Dosage: unknown dosage details
Indication: Product Used FOR Unknown Indication
Start date: 2011-01-01
End date: 2011-01-01
Methadone HCL
Indication: Product Used FOR Unknown Indication
Possible Suboxone side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-12
Patient: female, weighing 4.2 kg (9.2 pounds)
Reactions: Foetal Exposure During Pregnancy, Sudden Infant Death Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Subutex
Indication: Drug Dependence
Start date: 2011-05-09
End date: 2012-01-06
Suboxone
Indication: Drug Dependence
Start date: 2011-02-01
End date: 2011-05-09
Other drugs received by patient: Zofran; Klonopin
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-04
Patient: male
Reactions: Cleft Palate, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Opiates
Dosage: unknown dosage details
Indication: Product Used FOR Unknown Indication
Start date: 2004-01-01
End date: 2004-01-01
Suboxone
Indication: Drug Dependence
Start date: 2004-01-01
End date: 2005-01-01
Possible Suboxone side effects in male
Reported by a physician from United States on 2012-05-04
Patient: male, weighing 1.8 kg (4.1 pounds)
Reactions: LOW Birth Weight Baby, Foetal Exposure During Pregnancy, Premature Delivery
Drug(s) suspected as cause:
Buprenorphine
Indication: Drug Dependence
Start date: 2011-08-08
End date: 2012-03-22
Multi-Vitamins
Dosage: dosing details not provided; 1st trimester
Indication: Maternal Exposure During Pregnancy
Suboxone
Indication: Drug Dependence
Start date: 2011-07-06
End date: 2011-08-07
Vitamin D
Indication: Product Used FOR Unknown Indication
Start date: 2011-01-01
Calcium
Dosage: 1st trimester
Indication: Maternal Exposure During Pregnancy
Levothyroxine Sodium
Indication: Hypothyroidism
Possible Suboxone side effects in female
Reported by a physician from United States on 2012-05-03
Patient: female
Reactions: Foetal Exposure During Pregnancy, Sudden Infant Death Syndrome
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Suboxone
Indication: Drug Dependence
Start date: 2011-02-01
End date: 2011-05-09
Subutex
Indication: Drug Dependence
Start date: 2011-05-09
Other drugs received by patient: Klonopin; Zofran
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-03
Patient: male
Reactions: Respiratory Rate Increased, Neonatal Respiratory Distress Syndrome, Exposure During Breast Feeding, Foetal Exposure During Pregnancy, Neonatal Disorder, Irritability, Gastrooesophageal Reflux Disease, Head Titubation, Oxygen Saturation Decreased
Drug(s) suspected as cause:
Suboxone
Dosage: 16 mg, tapered to 4 or 6 mg daily
Indication: Drug Dependence
Start date: 2011-05-25
End date: 2012-02-07
Suboxone
Dosage: 4-6 mg daily
Indication: Drug Dependence
Start date: 2012-02-22
Possible Suboxone side effects in female
Reported by a consumer/non-health professional from United States on 2012-05-02
Patient: female, weighing 7.7 kg (16.9 pounds)
Reactions: Respiratory Disorder Neonatal, Premature Baby, Developmental Delay, Foetal Exposure During Pregnancy, Gastrooesophageal Reflux Disease, Tremor Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Subutex
Dosage: various doses
Indication: Drug Dependence
Start date: 2011-05-01
End date: 2011-09-23
Buprenorphine
Dosage: various doses
Indication: Drug Dependence
Start date: 2011-05-01
End date: 2011-09-23
Suboxone
Dosage: various doses
Indication: Drug Dependence
Start date: 2011-05-01
End date: 2011-09-23
Other Opiates
Dosage: unknown dosing regimen
Indication: Drug Dependence
Start date: 2011-05-01
End date: 2011-09-23
Suboxone
Dosage: 4 mg daily
Indication: Drug Dependence
Start date: 2011-01-01
End date: 2011-05-01
Suboxone
Dosage: various doses
Start date: 2011-05-01
End date: 2011-09-23
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-04-27
Patient: male, weighing 4.0 kg (8.8 pounds)
Reactions: Blood Glucose Decreased, Contusion, Exposure During Breast Feeding, Foetal Exposure During Pregnancy, Large FOR Dates Baby, Jaundice Neonatal, Dermatitis Diaper
Drug(s) suspected as cause:
Buprenorphine
Dosage: various doses daily
Indication: Drug Dependence
Start date: 2011-07-01
End date: 2012-02-13
Buprenorphine
Start date: 2012-02-25
Suboxone
Indication: Drug Dependence
Start date: 2011-05-01
End date: 2011-07-01
Opiates
Dosage: unknown dosage details
Indication: Pain
Start date: 2012-02-15
End date: 2012-02-24
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