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Index of reports
> Cases with Drug Withdrawal Syndrome Neonatal (49)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Suboxone (Buprenorphine / Naloxone) where reactions include drug withdrawal syndrome neonatal. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 49 Next >>
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 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 2012-08-09
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 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 2012-06-08
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 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 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 female
Reported by a individual with unspecified qualification from United States on 2012-02-28
Patient: female
Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Subutex
Dosage: (6 mg transplacental)
Indication: Drug Dependence
Start date: 2010-09-01
End date: 2011-05-22
Suboxone
Dosage: (8 mg transplacental)
Indication: Drug Dependence
Start date: 2010-08-01
End date: 2010-09-01
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: male
Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Subutex
Dosage: (20 mg transplacental)
Indication: Drug Dependence
Start date: 2009-06-01
End date: 2010-01-18
Suboxone
Dosage: (16 mg transplacental)
Indication: Drug Dependence
Start date: 2009-04-01
End date: 2009-06-01
Other drugs received by patient: Xanax (Unknown Until 01 / 18 / 2010); Soma (Unknown Until 01 / 18 / 2010)
Possible Suboxone side effects in male
Reported by a individual with unspecified qualification from United States on 2012-02-28
Patient: male
Reactions: Poor Sucking Reflex, Irritability, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Buprenorphine
Dosage: (20 mg transplacental), (20 mg transmammary)
Indication: Drug Dependence
Start date: 2011-06-01
End date: 2011-06-11
Buprenorphine
Dosage: (20 mg transplacental), (20 mg transmammary)
Indication: Drug Dependence
Start date: 2010-01-01
End date: 2011-06-01
Suboxone
Dosage: (20 mg stop date: first trimester transplacental), (20 mg transmammary)
Indication: Drug Dependence
Start date: 2011-06-12
End date: 2011-07-01
Suboxone
Dosage: (20 mg stop date: first trimester transplacental), (20 mg transmammary)
Indication: Drug Dependence
Start date: 2010-08-01
End date: 2010-01-01
Possible Suboxone side effects in male
Reported by a individual with unspecified qualification from United States on 2012-02-28
Patient: male, weighing 3.7 kg (8.1 pounds)
Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Subutex
Dosage: (3 mg transplacental)
Indication: Drug Dependence
End date: 2011-03-06
Suboxone
Dosage: (3 mg transplacental)
Indication: Drug Dependence
Start date: 2010-05-27
Possible Suboxone side effects in male
Reported by a pharmacist from United States on 2012-02-28
Patient: male
Reactions: Agitation, Exposure During Breast Feeding, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Suboxone
Dosage: (transmammary)
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-01
End date: 2011-03-01
Subutex
Dosage: (transplacental)
Indication: Product Used FOR Unknown Indication
End date: 2011-03-01
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: male
Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Crying, Tremor
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Suboxone
Dosage: (varied doses of 8 to 32 mg daily transplacental)
Indication: Drug Dependence
Start date: 2010-12-01
End date: 2011-03-27
Topamax
Dosage: (transplacental)
Indication: Migraine
Start date: 2010-07-01
End date: 2011-09-01
Suboxone
Dosage: transplacental
Indication: Drug Dependence
End date: 2010-01-01
Klonopin
Dosage: (transplacental)
Indication: Anxiety
Start date: 2010-07-01
End date: 2011-04-07
Possible Suboxone side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: female
Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Suboxone
Dosage: (dosing information unknown transplacental)
Indication: Substance Abuse
End date: 2010-12-01
Subutex
Dosage: (16 mg transplacental)
Indication: Drug Dependence
Start date: 2010-12-01
End date: 2011-07-01
Possible Suboxone side effects in female
Reported by a individual with unspecified qualification from United States on 2012-02-28
Patient: female
Reactions: Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Subutex
Dosage: (8 mg tid transplacental)
Indication: Drug Dependence
Start date: 2010-04-01
End date: 2010-11-28
Suboxone
Dosage: (8 mg tid transplacental)
Indication: Drug Dependence
Start date: 2008-01-01
End date: 2010-04-01
Possible Suboxone side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: male
Reactions: Viral Infection, Pyrexia, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Suboxone
Possible Suboxone side effects in male
Reported by a individual with unspecified qualification from United States on 2012-02-28
Patient: male
Reactions: Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Suboxone
Possible Suboxone side effects in female
Reported by a individual with unspecified qualification from United States on 2012-02-28
Patient: female
Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Suboxone
Dosage: transplacental
Indication: Product Used FOR Unknown Indication
Subutex
Dosage: transplacental, continued for 9 months after birth unknown
Indication: Product Used FOR Unknown Indication
Possible Suboxone side effects in female
Reported by a individual with unspecified qualification from United States on 2012-02-28
Patient: female
Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Suboxone
Dosage: (transplacental)
Indication: Substance Abuse
End date: 2010-12-01
Subutex
Dosage: (16 mg transplacental)
Indication: Drug Dependence
Start date: 2010-12-01
End date: 2011-07-01
Possible Suboxone side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-28
Patient: male
Reactions: Abdominal Pain, Exposure During Breast Feeding, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Subutex
Dosage: (16-24 transplacental)
Indication: Drug Dependence
Start date: 2010-01-01
End date: 2011-03-20
Suboxone
Dosage: (transplacental)
Indication: Drug Dependence
Start date: 2010-01-01
End date: 2010-01-01
Subutex
Dosage: (16-24 mg transmammary)
Start date: 2011-03-21
Possible Suboxone side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-28
Patient: male
Reactions: Abdominal Pain, Exposure During Breast Feeding, Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Subutex
Dosage: (16-24 mg transplacental), (16-24 mg transmammary)
Indication: Drug Dependence
Start date: 2010-01-01
End date: 2011-03-20
Subutex
Dosage: (16-24 mg transplacental), (16-24 mg transmammary)
Indication: Drug Dependence
Start date: 2011-03-21
Suboxone
Dosage: (transplacental)
Indication: Drug Dependence
Start date: 2010-01-01
End date: 2010-01-01
Possible Suboxone side effects in male
Reported by a physician from United States on 2012-02-28
Patient: male, weighing 3.3 kg (7.3 pounds)
Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Neurontin
Dosage: (600 mg bid transplacental)
Indication: Neuropathy Peripheral
End date: 2011-09-27
Xanax
Dosage: (2 mg tid transplacental)
Indication: Anxiety
End date: 2011-09-27
Suboxone
Dosage: (dosing information unknown transplacental)
Indication: Product Used FOR Unknown Indication
End date: 2011-09-27
Progesterone
Dosage: (dosing details unknown transplacental)
Indication: Shortened Cervix
End date: 2011-09-27
Other drugs received by patient: Multi-Vitamins
Possible Suboxone side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: female
Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Suboxone
Dosage: (8 mg transplacental)
Indication: Drug Dependence
Start date: 2010-08-01
End date: 2010-09-01
Subutex
Dosage: (6 mg transplacental)
Indication: Drug Dependence
Start date: 2010-09-01
End date: 2011-05-22
Possible Suboxone side effects in female
Reported by a consumer/non-health professional from United States on 2012-02-28
Patient: female
Reactions: Drug Withdrawal Syndrome Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Suboxone
Dosage: 8 mg tid transplacental
Indication: Drug Dependence
Start date: 2008-01-01
End date: 2010-04-01
Subutex
Dosage: 8 mg tid
Indication: Drug Dependence
Start date: 2010-04-01
End date: 2010-11-28
Possible Suboxone side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-28
Patient: male
Reactions: Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Subutex
Dosage: 8 mg transmammary
Indication: Drug Dependence
Start date: 2011-02-01
Subutex
Dosage: (8 to 16 milligram transplacental)
Indication: Drug Dependence
Start date: 2011-02-01
Subutex
Dosage: (8 to 16 milligram transplacental)
Indication: Drug Dependence
Start date: 2010-06-29
End date: 2011-02-01
Suboxone
Dosage: (4 to 8 milligrams daily transplacental)
Indication: Drug Dependence
Start date: 2010-04-01
End date: 2010-06-28
Possible Suboxone side effects in 50 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-28
Patient: 50 year old male
Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal, Dermatitis Diaper
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Opioids (None)
Dosage: (transplacental)
Indication: Drug Dependence
Suboxone
Dosage: (varied doses transplacental)
Indication: Drug Dependence
End date: 2011-05-10
Possible Suboxone side effects in
Reported by a physician from United States on 2012-02-28
Patient:
Reactions: Foetal Exposure During Pregnancy, Drug Withdrawal Syndrome Neonatal
Drug(s) suspected as cause:
Suboxone
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