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Betamethasone (Betamethasone Topical) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Betamethasone (Betamethasone Topical) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (152)
Death (21)
Life Threatening Events (17)
Disability (4)

Reports by Reaction Type

Maternal Exposure During Pregnancy (25)Foetal Exposure During Pregnancy (24)Premature Baby (22)LOW Birth Weight Baby (15)Premature Delivery (12)Drug Ineffective (11)Eczema (9)Condition Aggravated (8)Death Neonatal (8)Insomnia (8)Pancreatitis Acute (7)Coma (7)

Below are a few examples of reports where side effects / adverse reactions may be related to Betamethasone (Betamethasone Topical). For a complete list or a specific selection of reports, please use the links above.

Possible Betamethasone side effects in

Reported by a physician from Japan on 2012-08-25

Patient:

Reactions: Pneumocystis Jiroveci Pneumonia, Multi-Organ Failure, Disseminated Intravascular Coagulation, Shock

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Betamethasone
    Dosage: 4 mg, qd

Temodal
    Indication: Glioblastoma



Possible Betamethasone side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient: 19 year old female

Reactions: Pancreatitis Acute, Glycosylated Haemoglobin Increased, Drug Ineffective, Maternal Exposure During Pregnancy, Diet Noncompliance, Treatment Noncompliance, Hypertriglyceridaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Indication: Product Used FOR Unknown Indication

Atorvastatin
    Indication: Hypertriglyceridaemia

Betamethasone
    Indication: Maternal Therapy To Enhance Foetal Lung Maturity

Fenofibrate
    Indication: Hypertriglyceridaemia

Folic Acid
    Indication: Product Used FOR Unknown Indication

Insulin

Insulin
    Indication: Diabetes Mellitus



Possible Betamethasone side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient: 19 year old female

Reactions: Pancreatitis Acute, Maternal Exposure During Pregnancy, Hypertriglyceridaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Dosage: 75 mg, qd

Atorvastatin
    Dosage: 40 mg, at night
    Indication: Hypertriglyceridaemia

Betamethasone
    Dosage: 20 ug/hr, unk

Fenofibrate
    Dosage: 200 mg, at night

Folic Acid
    Dosage: 5 mg, qd

Insulin
    Dosage: 20 ug/hr, unk
    Indication: Maternal Therapy To Enhance Foetal Lung Maturity



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, 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, 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 19 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient: 19 year old female

Reactions: Pancreatitis Acute, Glycosylated Haemoglobin Increased, Drug Ineffective, Maternal Exposure During Pregnancy, Diet Noncompliance, Treatment Noncompliance, Hypertriglyceridaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Indication: Product Used FOR Unknown Indication

Atorvastatin
    Indication: Hypertriglyceridaemia

Betamethasone
    Indication: Maternal Therapy To Enhance Foetal Lung Maturity

Fenofibrate
    Indication: Hypertriglyceridaemia

Folic Acid
    Indication: Product Used FOR Unknown Indication

Insulin
    Indication: Diabetes Mellitus

Insulin



Possible Betamethasone side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-23

Patient: 19 year old female

Reactions: Pancreatitis Acute, Glycosylated Haemoglobin Increased, Drug Ineffective, Maternal Exposure During Pregnancy, Premature Delivery, Hypertriglyceridaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetylsalicylic Acid SRT
    Dosage: 75 mg

Atorvastatin
    Dosage: 40 mg
    Indication: Hyperlipidaemia

Betamethasone
    Indication: Maternal Therapy To Enhance Foetal Lung Maturity

Fenofibrate
    Dosage: 200 mg
    Indication: Hypertriglyceridaemia

Folic Acid
    Dosage: 5 mg

Insulin
    Indication: Diabetes Mellitus

Insulin
    Dosage: 300 u per day



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:
Aspirin

Atorvastatin

Betamethasone

Fenofibrate

Folic Acid

Insulin



Possible Betamethasone side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-22

Patient: 19 year old female

Reactions: Pancreatitis Acute, Glycosylated Haemoglobin Increased, Premature Delivery, Hypertriglyceridaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: daily dose 75 mg

Atorvastatin
    Dosage: daily dose 40 mg
    Indication: Hypertriglyceridaemia

Betamethasone
    Indication: Maternal Therapy To Enhance Foetal Lung Maturity

Fenofibrate
    Dosage: 200 mg, unk
    Indication: Hypertriglyceridaemia

Folic Acid
    Dosage: daily dose 5 mg

Insulin
    Dosage: 20 units/h

Insulin
    Indication: Diabetes Mellitus

Insulin
    Dosage: 5 u/kg per day



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 19 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-17

Patient: 19 year old female

Reactions: Pancreatitis Acute, Maternal Exposure During Pregnancy, Hypertriglyceridaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: 75 mg, qd

Atorvastatin
    Dosage: 40 mg, at night
    Indication: Hypertriglyceridaemia

Betamethasone
    Dosage: 20 ug/hr, unk

Fenofibrate
    Dosage: 200 mg, at night

Folic Acid
    Dosage: 5 mg, qd

Insulin
    Dosage: 20 ug/hr, unk
    Indication: Maternal Therapy To Enhance Foetal Lung Maturity



Possible Betamethasone side effects in 19 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-17

Patient: 19 year old female

Reactions: Pancreatitis Acute, Glycosylated Haemoglobin Increased, Drug Ineffective, Maternal Exposure During Pregnancy, Premature Delivery, Hypertriglyceridaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aspirin
    Dosage: 75 mg

Atorvastatin
    Dosage: 40 mg
    Indication: Hyperlipidaemia

Betamethasone
    Indication: Maternal Therapy To Enhance Foetal Lung Maturity

Fenofibrate
    Dosage: 200 mg
    Indication: Hypertriglyceridaemia

Folic Acid
    Dosage: 5 mg

Insulin
    Indication: Diabetes Mellitus

Insulin
    Dosage: 300 u per day



Possible Betamethasone side effects in

Reported by a physician from Japan on 2012-08-13

Patient:

Reactions: Platelet Count Decreased, Erythema Multiforme

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Betamethasone
    Dosage: unk mg, unk
    Start date: 2012-04-10
    End date: 2012-05-07

Flagyl
    Dosage: 1000 mg, unk
    Start date: 2012-04-29
    End date: 2012-05-12

Flagyl
    Dosage: 1000 mg, unk
    Administration route: Oral
    Indication: Pseudomembranous Colitis
    Start date: 2012-04-03
    End date: 2012-04-04

Vancomycin Hydrochloride
    Dosage: 1 g, unk
    Start date: 2012-04-16
    End date: 2012-04-29

Zyvox
    Dosage: 1200 mg, unk

Other drugs received by patient: Lebenin; Yunasupin; Gentamicin Sulfate; Dorner; Lebenin; Pydoxal; Nizoral; Methylprednisolone Sodium Succinate; Targocid; Dorner; Myser (Difluprednate); Olopatadine HCL; Prednisolone; Nicoranta; Plavix; Trichlormethiazide; Vancomycin Hydrochloride; Aspara K; Myser (Difluprednate); Plavix; Aldactone; Aspara K



Possible Betamethasone side effects in male

Reported by a physician from Japan on 2012-08-02

Patient: male

Reactions: Salmonella Sepsis, Hepatic Function Abnormal, Castleman's Disease, Platelet Count Decreased, Rash

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Betamethasone
    Dosage: 1 df, tid
    Administration route: Oral
    Indication: Rash
    Start date: 2010-01-18
    End date: 2010-01-26

Betamethasone
    Dosage: 1 df, tid
    Administration route: Oral
    Start date: 2010-01-27
    End date: 2010-01-31

Norvir
    Dosage: 100 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-01-08
    End date: 2010-01-21

Prezista
    Dosage: 800 mg, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-01-08
    End date: 2010-01-21

Truvada
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2010-01-08

Truvada
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2010-08-16

Truvada
    Dosage: 1 df, qd
    Administration route: Oral
    Start date: 2010-02-08
    End date: 2012-06-30

Other drugs received by patient: Efavirenz; Isentress; Epivir; Zerit; Loperamide Hydrochloride



Possible Betamethasone side effects in 67 year old male

Reported by a health professional (non-physician/pharmacist) from Greece on 2012-07-31

Patient: 67 year old male

Reactions: Dyspnoea, Fatigue, Hiccups

Drug(s) suspected as cause:
Betamethasone
    Dosage: 12 mg, single
    Indication: Pain

Metoclopramide Injection
    Dosage: unk
    Administration route: Oral
    Indication: Hiccups



Possible Betamethasone side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-30

Patient:

Reactions: Maternal Exposure During Pregnancy, Pulmonary Oedema

Drug(s) suspected as cause:
Betamethasone
    Dosage: unk
    Indication: Maternal Therapy To Enhance Foetal Lung Maturity

Ritodrine Hydrochloride
    Indication: Threatened Labour

Other drugs received by patient: Magnesium Sulfate



Possible Betamethasone side effects in 57 year old male

Reported by a individual with unspecified qualification from Brazil on 2012-07-24

Patient: 57 year old male

Reactions: Blood Pressure Systolic Increased, Drug Ineffective, Dental Implantation, Anal Fissure

Drug(s) suspected as cause:
Amoxicillin
    Dosage: 500 mg, per oral
    Administration route: Oral
    Indication: Dental Implantation
    Start date: 2011-11-01

Benicar HCT
    Dosage: 40/12.5 mg (1 in 1 d), per oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-01-01
    End date: 2012-02-01

Betamethasone
    Dosage: 2 mg, per oral
    Administration route: Oral
    Indication: Dental Implantation
    Start date: 2011-11-01

Celecoxib
    Dosage: per oral
    Administration route: Oral
    Indication: Dental Implantation
    Start date: 2011-11-01

Other drugs received by patient: Anti-Inflammatory Medicine FOR Spine Disorder (Name Unknown) (Antiinfl; Amlodipine



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 physician from Italy on 2012-07-17

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Rectal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Betamethasone
    Dosage: 4 mg, unk

Blinded NO Treatment Received
    Dosage: double blinded
    Administration route: Oral
    Start date: 2012-06-29

Blinded NO Treatment Received
    Dosage: double blinded
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2010-09-23
    End date: 2012-06-18

Enalapril Maleate
    Dosage: double blinded
    Administration route: Oral
    Start date: 2012-06-29

Enalapril Maleate
    Dosage: double blinded
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2010-09-23
    End date: 2012-06-18

Thiocolchicoside

Tramadol HCL

Valsartan
    Dosage: double blinded
    Administration route: Oral
    Indication: Cardiac Failure Chronic
    Start date: 2010-09-23
    End date: 2012-06-18

Valsartan
    Dosage: double blinded
    Administration route: Oral
    Start date: 2012-06-29

Voltaren
    Dosage: 75 mg, unk

Other drugs received by patient: Simvastatin; Omeprazole; Furosemide; Aspirin; Metoprolol Tartrate



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 female

Reported by a consumer/non-health professional from United States on 2012-07-12

Patient: female

Reactions: Arthralgia, Muscular Weakness, Headache, Asthenia

Drug(s) suspected as cause:
Betamethasone

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