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Index of reports
> Cases with Premature Baby (22)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Betamethasone (Betamethasone Topical) where reactions include premature baby. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Betamethasone side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient: male, weighing 2.4 kg (5.2 pounds)
Reactions: LOW Birth Weight Baby, Brain Malformation, Premature Baby, Foetal Exposure During Pregnancy, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Atorvastatin
Dosage: 40 mg, (maternal dose)
Fenofibrate
Dosage: 200 mg (maternal dose)
Insulin
Dosage: 300 u, (maternal dose)
Betamethasone
Dosage: 20 ug/hr (maternal dose)
Acetylsalicylic Acid SRT
Dosage: 75 mg,(maternal dose)
Folic Acid
Dosage: 5 mg, (maternal dose)
Possible Betamethasone side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient: male, weighing 2.4 kg (5.2 pounds)
Reactions: LOW Birth Weight Baby, Premature Baby, Brain Malformation, Foetal Exposure During Pregnancy, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
Dosage: 75 mg,(maternal dose)
Betamethasone
Dosage: 20 ug/hr (maternal dose)
Atorvastatin
Dosage: 40 mg, (maternal dose)
Fenofibrate
Dosage: 200 mg (maternal dose)
Folic Acid
Dosage: 5 mg, (maternal dose)
Insulin
Dosage: 300 u, (maternal dose)
Possible Betamethasone side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-22
Patient: male, weighing 2.4 kg (5.2 pounds)
Reactions: Premature Baby, Cerebral Dysgenesis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Atorvastatin
Aspirin
Folic Acid
Fenofibrate
Betamethasone
Insulin
Possible Betamethasone side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-17
Patient: male, weighing 2.4 kg (5.2 pounds)
Reactions: LOW Birth Weight Baby, Premature Baby, Brain Malformation, Foetal Exposure During Pregnancy, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betamethasone
Dosage: 20 ug/hr (maternal dose)
Atorvastatin
Dosage: 40 mg, (maternal dose)
Insulin
Dosage: 300 u, (maternal dose)
Fenofibrate
Dosage: 200 mg (maternal dose)
Folic Acid
Dosage: 5 mg, (maternal dose)
Aspirin
Dosage: 75 mg,(maternal dose)
Possible Betamethasone side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-17
Patient: male, weighing 2.4 kg (5.2 pounds)
Reactions: LOW Birth Weight Baby, Brain Malformation, Premature Baby, Foetal Exposure During Pregnancy, Convulsion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Atorvastatin
Dosage: 40 mg, (maternal dose)
Betamethasone
Dosage: 20 ug/hr (maternal dose)
Insulin
Dosage: 300 u, (maternal dose)
Aspirin
Dosage: 75 mg,(maternal dose)
Folic Acid
Dosage: 5 mg, (maternal dose)
Fenofibrate
Dosage: 200 mg (maternal dose)
Possible Betamethasone side effects in
Reported by a physician from Poland on 2012-07-23
Patient:
Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Possible Betamethasone side effects in
Reported by a physician from Poland on 2012-07-23
Patient:
Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Possible Betamethasone side effects in
Reported by a physician from Poland on 2012-07-23
Patient:
Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Possible Betamethasone side effects in
Reported by a physician from Poland on 2012-07-23
Patient:
Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Possible Betamethasone side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-11
Patient: female
Reactions: Asthma, Retinopathy of Prematurity, Congenital Central Nervous System Anomaly, Meningitis Neonatal, Strabismus, Pharyngotonsillitis, Developmental Delay, Intraventricular Haemorrhage Neonatal, Patent Ductus Arteriosus, Emotional Disorder, Gastrooesophageal Reflux Disease, Cleft LIP and Palate, Apgar Score LOW, Premature Baby, Malocclusion, Abnormal Behaviour, Bronchopulmonary Dysplasia, Nasal Septum Deviation, Lung Disorder, Sepsis, Enlarged Clitoris, Attention Deficit / Hyperactivity Disorder, Sleep Apnoea Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Topamax
Indication: Foetal Exposure During Pregnancy
Start date: 2001-01-01
End date: 2007-01-01
Prometrium
Indication: Foetal Exposure During Pregnancy
Nifedipine
Indication: Foetal Exposure During Pregnancy
Terbutaline
Indication: Foetal Exposure During Pregnancy
Lithium Carbonate
Indication: Foetal Exposure During Pregnancy
Clindamycin
Indication: Foetal Exposure During Pregnancy
Lexapro
Indication: Foetal Exposure During Pregnancy
Zithromax
Indication: Foetal Exposure During Pregnancy
Betamethasone
Indication: Foetal Exposure During Pregnancy
Ampicillin
Indication: Foetal Exposure During Pregnancy
Possible Betamethasone side effects in male
Reported by a health professional (non-physician/pharmacist) from Poland on 2012-06-05
Patient: male
Reactions: Premature Baby, Foetal Exposure During Pregnancy, Haemorrhage Intracranial
Drug(s) suspected as cause:
Digitalis
Dosage: maternal dose of 0.1 mg/day
Enalapril Maleate
Dosage: 2.5 mg, qd
Metoprolol Tartrate
Dosage: maternal dose of 50-75 mg/day
Betamethasone
Enalapril Maleate
Dosage: maternal dose of 5 mg, bid
Isosorbide Mononitrate
Dosage: maternal dose of 20 mg, bid
Spironolactone
Dosage: maternal dose of 12.5 mg/day
Furosemide
Dosage: maternal dose of 40 mg
Dihydralazine
Dosage: maternal dose of 25 mg, tid
Possible Betamethasone side effects in male
Reported by a health professional (non-physician/pharmacist) from Poland on 2012-06-05
Patient: male
Reactions: Caesarean Section, Premature Baby, Haemorrhage Intracranial, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Dihydralazine
Dosage: maternal dose of 25 mg, tid
Enalapril Maleate
Dosage: 2.5 mg, qd
Furosemide
Dosage: maternal dose of 40 mg
Metoprolol Tartrate
Dosage: maternal dose of 50-75 mg/day
Isosorbide Mononitrate
Dosage: maternal dose of 20 mg, bid
Spironolactone
Dosage: maternal dose of 12.5 mg/day
Betamethasone
Digitalis
Dosage: maternal dose of 0.1 mg/day
Enalapril Maleate
Dosage: maternal dose of 5 mg, bid
Possible Betamethasone side effects in male
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-20
Patient: male, weighing 0.8 kg (1.7 pounds)
Reactions: LOW Birth Weight Baby, Foetal Growth Restriction, Blood Glucose Decreased, Premature Baby, Foetal Exposure During Pregnancy, Tachypnoea, Abdominal Distension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Nicardipine HCL
Dosage: 120 mg, daily
Indication: Blood Pressure Increased
Start date: 2011-04-15
End date: 2011-04-16
Propofol
Rocuronium Bromide
Betamethasone
AOS
Neupogen
Fentanyl-100
Sugammadex
Other drugs received by patient: Propofol; Midazolam; Rocuronium Bromide; Atarax; Fentanyl-100; Sevoflurane; Glucose
Possible Betamethasone side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-12
Patient: female
Reactions: Asthma, Retinopathy of Prematurity, Congenital Central Nervous System Anomaly, Meningitis Neonatal, Strabismus, Pharyngotonsillitis, Developmental Delay, Intraventricular Haemorrhage Neonatal, Patent Ductus Arteriosus, Emotional Disorder, Gastrooesophageal Reflux Disease, Cleft LIP and Palate, Apgar Score LOW, Premature Baby, Abnormal Behaviour, Malocclusion, Bronchopulmonary Dysplasia, Nasal Septum Deviation, Lung Disorder, Sepsis, Enlarged Clitoris, Sleep Apnoea Syndrome, Attention Deficit / Hyperactivity Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Zithromax
Indication: Foetal Exposure During Pregnancy
Nifedipine
Indication: Foetal Exposure During Pregnancy
Terbutaline
Indication: Foetal Exposure During Pregnancy
Betamethasone
Indication: Foetal Exposure During Pregnancy
Topamax
Indication: Foetal Exposure During Pregnancy
Start date: 2001-01-01
End date: 2007-01-01
Clindamycin
Indication: Foetal Exposure During Pregnancy
Ampicillin
Indication: Foetal Exposure During Pregnancy
Lexapro
Indication: Foetal Exposure During Pregnancy
Prometrium
Indication: Foetal Exposure During Pregnancy
Lithium Carbonate
Indication: Foetal Exposure During Pregnancy
Possible Betamethasone side effects in male
Reported by a consumer/non-health professional from Japan on 2012-04-09
Patient: male, weighing 0.8 kg (1.7 pounds)
Reactions: LOW Birth Weight Baby, Blood Glucose Decreased, Maternal Drugs Affecting Foetus, Caesarean Section, Premature Baby, Foetal Exposure During Pregnancy, Tachypnoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Propofol
Betamethasone
Fentanyl Citrate
Rocuronium Bromide
Nicardipine HCL
Dosage: 120 mg, daily
Indication: Blood Pressure Increased
Start date: 2011-04-15
End date: 2011-04-16
Sugammadex
AOS
Neupogen
Other drugs received by patient: Atarax; Glucose; Sevoflurane; Propofol; Rocuronium Bromide; Fentanyl Citrate; Midazolam
Possible Betamethasone side effects in female
Reported by a lawyer from United States on 2012-03-22
Patient: female
Reactions: Retinopathy of Prematurity, Congenital Central Nervous System Anomaly, Strabismus, Intraventricular Haemorrhage Neonatal, Developmental Delay, Patent Ductus Arteriosus, Emotional Disorder, Gastrooesophageal Reflux Disease, Cleft LIP and Palate, Apgar Score LOW, Premature Baby, Malocclusion, Bronchopulmonary Dysplasia, Nasal Septum Deviation, Lung Disorder, Sepsis, Enlarged Clitoris, Attention Deficit / Hyperactivity Disorder, Sleep Apnoea Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Topamax
Indication: Foetal Exposure During Pregnancy
Start date: 2001-01-01
End date: 2007-01-01
Lithium Carbonate
Indication: Foetal Exposure During Pregnancy
Terbutaline
Indication: Foetal Exposure During Pregnancy
Lexapro
Indication: Foetal Exposure During Pregnancy
Zithromax
Indication: Foetal Exposure During Pregnancy
Prometrium
Indication: Foetal Exposure During Pregnancy
Nifedipine
Indication: Foetal Exposure During Pregnancy
Betamethasone
Indication: Foetal Exposure During Pregnancy
Clindamycin
Indication: Foetal Exposure During Pregnancy
Ampicillin
Indication: Foetal Exposure During Pregnancy
Possible Betamethasone side effects in
Reported by a consumer/non-health professional from Japan on 2012-03-15
Patient:
Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Nicardipine HCL
Indication: Blood Pressure Increased
Sugammadex
Rocuronium Bromide
AOS
Betamethasone
Propofol
Neupogen
Fentanyl
Possible Betamethasone side effects in
Reported by a consumer/non-health professional from Japan on 2012-03-02
Patient:
Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Rocuronium Bromide
Fentanyl
AOS
Nicardipine Hydrochloride
Betamethasone
Neupogen
Propofol
Sugammadex
Other drugs received by patient: Midazolam; Nitrous Oxide
Possible Betamethasone side effects in
Reported by a health professional (non-physician/pharmacist) from Norway on 2012-02-09
Patient:
Reactions: Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Betamethasone
Dosage: trpl
Indication: Maternal Exposure During Pregnancy
Candesartan Cilexetil
Dosage: trpl
Indication: Product Used FOR Unknown Indication
Aspirin
Dosage: trpl
Indication: Product Used FOR Unknown Indication
Atosiban (Atosiban)
Dosage: trpl
Indication: Product Used FOR Unknown Indication
Metoprolol Tartrate
Dosage: trpl
Indication: Product Used FOR Unknown Indication
Possible Betamethasone side effects in
Reported by a individual with unspecified qualification from Japan on 2011-12-19
Patient: , weighing 1288.0 kg (2833.6 pounds)
Reactions: Congenital Tuberculosis, LOW Birth Weight Baby, Neonatal Respiratory Distress Syndrome, Premature Baby, Foetal Exposure During Pregnancy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rifampicin
Ethambutol Hydrochloride
Ritodrine Hydrochloride
Betamethasone
Dosage: unk
Isoniazid
Dosage: unk
Possible Betamethasone side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-15
Patient: female, weighing 0.5 kg (1.1 pounds)
Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Growth Retardation
Drug(s) suspected as cause:
Betamethasone
Epoprostenol Sodium
Dosage: 26 ng/kg/min
Oxygen
Dosage: 6 l/min
Enoxaparin
Dosage: 30 mg, 2x/day
Enoxaparin
Dosage: unk
Epoprostenol Sodium
Dosage: 6 ng/kg/min
Pantoprazole
Indication: Nausea
Possible Betamethasone side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-15
Patient: female, weighing 0.5 kg (1.1 pounds)
Reactions: LOW Birth Weight Baby, Premature Baby, Growth Retardation, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Enoxaparin
Dosage: 30 mg, 2x/day
Enoxaparin
Dosage: unk
Pantoprazole
Indication: Nausea
Oxygen
Dosage: 6 l/min
Epoprostenol
Dosage: 6 ng/kg/min
Betamethasone
Epoprostenol Sodium
Dosage: 26 ng/kg/min
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