Index of reports
> Cases with LOW Birth Weight Baby (15)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Betamethasone (Betamethasone Topical) where reactions include low birth weight 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:
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, 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 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 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, Growth Retardation, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Betamethasone
Enoxaparin
Dosage: 30 mg, 2x/day
Enoxaparin
Dosage: unk
Epoprostenol
Dosage: 6 ng/kg/min
Epoprostenol Sodium
Dosage: 26 ng/kg/min
Oxygen
Dosage: 6 l/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, 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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