Index of reports
> Cases with Foetal Exposure During Pregnancy (24)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Betamethasone (Betamethasone Topical) where reactions include foetal exposure during pregnancy. 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:
Acetylsalicylic Acid SRT
Dosage: 75 mg,(maternal dose)
Atorvastatin
Dosage: 40 mg, (maternal dose)
Betamethasone
Dosage: 20 ug/hr (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 2012-08-23
Patient: male
Reactions: Congenital Central Nervous System Anomaly, Foetal Exposure During Pregnancy, Convulsion Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
Atorvastatin
Betamethasone
Fenofibrate
Folic Acid
Insulin
Possible Betamethasone side effects in male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23
Patient: male
Reactions: Congenital Central Nervous System Anomaly, Foetal Exposure During Pregnancy, Convulsion Neonatal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
Atorvastatin
Betamethasone
Fenofibrate
Folic Acid
Insulin
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)
Atorvastatin
Dosage: 40 mg, (maternal dose)
Betamethasone
Dosage: 20 ug/hr (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 2012-08-17
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:
Aspirin
Dosage: 75 mg,(maternal dose)
Atorvastatin
Dosage: 40 mg, (maternal dose)
Betamethasone
Dosage: 20 ug/hr (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 2012-08-17
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:
Aspirin
Dosage: 75 mg,(maternal dose)
Atorvastatin
Dosage: 40 mg, (maternal dose)
Betamethasone
Dosage: 20 ug/hr (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
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:
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
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:
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
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:
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
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:
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Possible Betamethasone side effects in
Reported by a physician from Poland on 2012-07-13
Patient:
Reactions: Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Possible Betamethasone side effects in
Reported by a physician from Poland on 2012-07-13
Patient:
Reactions: Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Possible Betamethasone side effects in
Reported by a physician from Poland on 2012-07-13
Patient:
Reactions: Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
Possible Betamethasone side effects in
Reported by a physician from Poland on 2012-07-13
Patient:
Reactions: Foetal Exposure During Pregnancy, Death Neonatal
Adverse event resulted in: death
Drug(s) suspected as cause:
Betamethasone
Indication: Maternal Exposure Timing Unspecified
Fenoterol Hydrobromide
Indication: Maternal Exposure Timing Unspecified
Progesterone
Indication: Maternal Exposure Timing Unspecified
Verapamil HCL
Indication: Maternal Exposure Timing Unspecified
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:
Betamethasone
Digitalis
Dosage: maternal dose of 0.1 mg/day
Dihydralazine
Dosage: maternal dose of 25 mg, tid
Enalapril Maleate
Dosage: 2.5 mg, qd
Enalapril Maleate
Dosage: maternal dose of 5 mg, bid
Furosemide
Dosage: maternal dose of 40 mg
Isosorbide Mononitrate
Dosage: maternal dose of 20 mg, bid
Metoprolol Tartrate
Dosage: maternal dose of 50-75 mg/day
Spironolactone
Dosage: maternal dose of 12.5 mg/day
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:
Betamethasone
Digitalis
Dosage: maternal dose of 0.1 mg/day
Dihydralazine
Dosage: maternal dose of 25 mg, tid
Enalapril Maleate
Dosage: 2.5 mg, qd
Enalapril Maleate
Dosage: maternal dose of 5 mg, bid
Furosemide
Dosage: maternal dose of 40 mg
Isosorbide Mononitrate
Dosage: maternal dose of 20 mg, bid
Metoprolol Tartrate
Dosage: maternal dose of 50-75 mg/day
Spironolactone
Dosage: maternal dose of 12.5 mg/day
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:
AOS
Betamethasone
Fentanyl-100
Neupogen
Nicardipine HCL
Dosage: 120 mg, daily
Indication: Blood Pressure Increased
Start date: 2011-04-15
End date: 2011-04-16
Propofol
Rocuronium Bromide
Sugammadex
Other drugs received by patient: Propofol; Midazolam; Rocuronium Bromide; Atarax; Fentanyl-100; Sevoflurane; Glucose
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:
AOS
Betamethasone
Fentanyl Citrate
Neupogen
Nicardipine HCL
Dosage: 120 mg, daily
Indication: Blood Pressure Increased
Start date: 2011-04-15
End date: 2011-04-16
Propofol
Rocuronium Bromide
Sugammadex
Other drugs received by patient: Atarax; Glucose; Sevoflurane; Propofol; Rocuronium Bromide; Fentanyl Citrate; Midazolam
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:
AOS
Betamethasone
Fentanyl
Neupogen
Nicardipine HCL
Indication: Blood Pressure Increased
Propofol
Rocuronium Bromide
Sugammadex
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:
AOS
Betamethasone
Fentanyl
Neupogen
Nicardipine Hydrochloride
Propofol
Rocuronium Bromide
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:
Aspirin
Dosage: trpl
Indication: Product Used FOR Unknown Indication
Atosiban (Atosiban)
Dosage: trpl
Indication: Product Used FOR Unknown Indication
Betamethasone
Dosage: trpl
Indication: Maternal Exposure During Pregnancy
Candesartan Cilexetil
Dosage: trpl
Indication: Product Used FOR Unknown Indication
Metoprolol Tartrate
Dosage: trpl
Indication: Product Used FOR Unknown Indication
Possible Betamethasone side effects in male
Reported by a physician from United States on 2012-01-03
Patient: male
Reactions: Foetal Exposure During Pregnancy, Live Birth, Hyperthyroidism
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Betamethasone
Indication: Prenatal Care
Propranolol
Indication: Hypertension
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:
Betamethasone
Dosage: unk
Ethambutol Hydrochloride
Isoniazid
Dosage: unk
Rifampicin
Ritodrine Hydrochloride
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
Enoxaparin
Dosage: 30 mg, 2x/day
Enoxaparin
Dosage: unk
Epoprostenol Sodium
Dosage: 26 ng/kg/min
Epoprostenol Sodium
Dosage: 6 ng/kg/min
Oxygen
Dosage: 6 l/min
Pantoprazole
Indication: Nausea
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