Index of reports
> Cases with Foetal Growth Restriction (7)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Trandate (Labetalol) where reactions include foetal growth restriction. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Trandate side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-16
Patient: female
Reactions: Foetal Growth Restriction, Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Insulatard NPH Human
Dosage: (8 iu in morning, 4 iu in evening)
Indication: Diabetes Mellitus
End date: 2011-06-30
Aspirin
Dosage: 75 mg, qd
End date: 2011-06-30
Tacrolimus
Dosage: unk
End date: 2011-06-30
Amaryl
Dosage: 5 mg, qd
End date: 2011-06-30
Pravastatin
Dosage: 10 mg, qd
End date: 2011-06-30
Azathioprine
Dosage: 50 mg
End date: 2011-06-30
Prednisone TAB
Dosage: 6 mg, qd
End date: 2011-06-30
Colistin Sulfate
Dosage: unk
End date: 2011-06-30
Trandate
Dosage: unk
End date: 2011-06-30
Mucomyst
Dosage: 600 mg, qd
End date: 2011-06-30
Other drugs received by patient: Sterogyl / 00107901 /; Caltrate / 00751519 /; Ursolvan; Toco; Creon
Possible Trandate side effects in 8 month old female
Reported by a consumer/non-health professional from France on 2012-04-15
Patient: 8 month old female, weighing 1.0 kg (2.2 pounds)
Reactions: Foetal Growth Restriction
Drug(s) suspected as cause:
Imuran
Dosage: film coated tablet
End date: 2011-06-30
Aspirin
Dosage: form: powder for oral solution sachet
End date: 2011-06-30
Amlodipine Besylate
Dosage: capsule
End date: 2011-06-30
Pravastatin
Dosage: form: scored tabs
End date: 2011-06-30
Mucomyst
Dosage: 3 sachets 3 times a day
End date: 2011-06-30
Colimycine
Dosage: 1 df= 1 miu. form: powder and solvent for nebulizer solution
End date: 2011-06-30
Insulatard NPH Human
Dosage: 8iu morning + 4iu evening
End date: 2011-06-30
Tacrolimus
Dosage: increased to 12mg/day on 20may11
End date: 2011-06-30
Trandate
End date: 2011-06-30
Prednisone TAB
End date: 2011-06-30
Other drugs received by patient: Ergocalciferol; Creon; Toco; Calcium Carbonate; Ursolvan
Possible Trandate side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-13
Patient: female
Reactions: Foetal Growth Restriction, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Prednisone TAB
Dosage: 6 mg daily
Tacrolimus
Dosage: unk
Tacrolimus
Dosage: 12 mg daily
Start date: 2011-05-20
Pravastatin
Dosage: 10 mg, 1x/day
Indication: Dyslipidaemia
Mucomyst
Dosage: 600 mg, 3x/day
Imuran
Dosage: 50 mg, 1x/day
Aspirin
Dosage: 75 mg, 1x/day
Insulatard NPH Human
Dosage: 8 iu in the morning and 4 iu in the evening
Indication: Diabetes Mellitus
Trandate
Dosage: 100 mg daily
Indication: Hypertension
Amlodipine Besylate
Dosage: 5 mg, 1x/day
Indication: Hypertension
Colimycine
Dosage: unk
Other drugs received by patient: Toco; Calcium Carbonate; Ergocalciferol; Ursolvan-200; Creon; Aspegic 1000
Possible Trandate side effects in 8 month old female
Reported by a physician from France on 2012-04-03
Patient: 8 month old female, weighing 1.0 kg (2.2 pounds)
Reactions: Foetal Growth Restriction
Drug(s) suspected as cause:
Mucomyst
Dosage: 3 sachets 3 times a day
Insulatard NPH Human
Dosage: 8iu morning + 4iu evening
Pravastatin
Dosage: form: scored tabs
Imuran
Dosage: film coated tablet
End date: 2011-01-27
Trandate
Tacrolimus
Dosage: increased to 12mg/day on 20may11
End date: 2011-01-27
Amlodipine Besylate
Dosage: capsule
Prednisone TAB
End date: 2011-01-27
Colimycine
Dosage: 1 df= 1 miu. form: powder and solvent for nebulizer solution
Aspirin
Dosage: form: powder for oral solution sachet
Other drugs received by patient: Ursolvan; Creon; Toco; Ergocalciferol; Calcium Carbonate
Possible Trandate side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-30
Patient: female
Reactions: Foetal Growth Restriction, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Colimycine
Dosage: unk
Pravastatin
Dosage: 10 mg, 1x/day
Indication: Dyslipidaemia
Imuran
Dosage: 50 mg, 1x/day
Mucomyst
Dosage: 600 mg, 3x/day
Tacrolimus
Dosage: unk
Aspirin
Dosage: 75 mg, 1x/day
Insulatard NPH Human
Dosage: 8 iu in the morning and 4 iu in the evening
Indication: Diabetes Mellitus
Prednisone TAB
Dosage: 6 mg daily
Tacrolimus
Dosage: 12 mg daily
Start date: 2011-05-20
Trandate
Dosage: 100 mg daily
Indication: Hypertension
Amlodipine Besylate
Dosage: 5 mg, 1x/day
Indication: Hypertension
Other drugs received by patient: Sterogyl; Calcium Carbonate; Toco; Aspegic 1000; Ursolvan-200; Creon
Possible Trandate side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-29
Patient: female
Reactions: Foetal Growth Restriction, Premature Baby, Foetal Exposure During Pregnancy
Drug(s) suspected as cause:
Azathioprine
Dosage: 50 mg
End date: 2011-01-27
Tacrolimus
Dosage: unk
End date: 2011-01-27
Mucomyst
Dosage: 600 mg, qd
Colimycine / 00013203 /
Dosage: unk
Amaryl
Dosage: 5 mg
Pravastatin
Dosage: 10 mg, qd
Aspirin
Dosage: 75 mg, qd
Insulatard NPH Human
Dosage: 12 iu, qd
Indication: Diabetes Mellitus
Prednisone TAB
Dosage: 6 mg, qd
End date: 2011-01-27
Trandate
Dosage: unk
Other drugs received by patient: Caltrate / 00751519 /; Ursolvan; Creon; Sterogyl / 00107901 /; Toco
Possible Trandate side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-26
Patient: female
Reactions: Foetal Growth Restriction, Maternal Exposure Timing Unspecified
Drug(s) suspected as cause:
Insulatard NPH Human
Dosage: 8 iu in the morning and 4 iu in the evening
Indication: Diabetes Mellitus
Tacrolimus
Dosage: 12 mg daily
Start date: 2011-05-20
Amlodipine Besylate
Dosage: 5 mg, 1x/day
Indication: Hypertension
Prednisone TAB
Dosage: 6 mg daily
End date: 2011-01-27
Imuran
Dosage: 50 mg, 1x/day
End date: 2011-01-27
Colimycine
Mucomyst
Dosage: 600 mg, 3x/day
Trandate
Dosage: 100 mg daily
Indication: Hypertension
Pravastatin
Dosage: 10 mg, 1x/day
Indication: Dyslipidaemia
Tacrolimus
Dosage: unk
End date: 2011-01-27
Aspirin
Dosage: 75 mg, 1x/day
Other drugs received by patient: Toco; Ursolvan-200; Calcium Carbonate; Aspegic 1000; Sterogyl; Creon
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