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Apresoline (Hydralazine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Apresoline (Hydralazine) 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 (27)
Death (2)
Life Threatening Events (2)
Disability (2)

Reports by Reaction Type

Foetal Exposure During Pregnancy (7)Blood Pressure Increased (7)Premature Baby (7)Maternal Exposure During Pregnancy (7)Hypertension (7)Foetal Disorder (6)Cerebrovascular Accident (6)Feeling Abnormal (6)LOW Birth Weight Baby (5)Premature Delivery (5)Wrong Technique in Drug Usage Process (4)Headache (4)

Possible Apresoline side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-14

Patient:

Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Foetal Disorder, Foetal Growth Restriction, Foetal Distress Syndrome, Caesarean Section, Developmental Delay, Respiratory Disorder Neonatal, Breech Presentation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclosporine
    Dosage: maternal dose: 200 mgdaily

Apresoline
    Dosage: maternal dose unknown, oral
    Indication: Blood Pressure

Apresoline
    Dosage: maternal dose 6mg, intravenous

Other drugs received by patient: Prednisolone



Possible Apresoline side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-07

Patient: 32 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Chorioamnionitis, Maternal Exposure During Pregnancy, Foetal Disorder, Gestational Hypertension, Renal Impairment, Proteinuria, Oedema, Hypertension, Premature Delivery

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclosporine
    Dosage: 200 mg, daily
    Administration route: Oral
    Indication: Aplastic Anaemia

Apresoline
    Dosage: unk ukn, unk
    Administration route: Oral
    Indication: Blood Pressure

Apresoline
    Dosage: 6 mg, (injection), unk

Other drugs received by patient: Nicardipine HCL; Prednisolone; Fentanyl; Propofol; Rocuronium Bromide; Midazolam



Possible Apresoline side effects in 57 year old female

Reported by a consumer/non-health professional from Brazil on 2012-07-30

Patient: 57 year old female

Reactions: Blood Pressure Increased, Head Discomfort, Headache, Feeling Abnormal, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 2 df, daily

Apresoline
    Dosage: 1 df, daily.
    Indication: Cardiac Disorder

Other drugs received by patient: Lotigrel



Possible Apresoline side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-26

Patient:

Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Restriction, Developmental Delay, Respiratory Disorder Neonatal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apresoline
    Dosage: maternal dose 6mg, intravenous

Cyclosporine
    Dosage: maternal dose: 200 mgdaily

Apresoline
    Dosage: maternal dose unknown, oral
    Indication: Blood Pressure

Other drugs received by patient: Prednisolone



Possible Apresoline side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-07-26

Patient: 32 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Chorioamnionitis, Maternal Exposure During Pregnancy, Gestational Hypertension, Foetal Disorder, Renal Impairment, Proteinuria, Oedema, Hypertension, Premature Delivery

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apresoline
    Dosage: 6 mg, (injection), unk

Apresoline
    Dosage: unk ukn, unk
    Administration route: Oral
    Indication: Blood Pressure

Cyclosporine
    Dosage: 200 mg, daily
    Administration route: Oral
    Indication: Aplastic Anaemia

Other drugs received by patient: Propofol; Fentanyl; Midazolam; Nicardipine HCL; Prednisolone; Rocuronium Bromide



Possible Apresoline side effects in 57 year old female

Reported by a consumer/non-health professional from Brazil on 2012-06-25

Patient: 57 year old female

Reactions: Blood Pressure Increased, Head Discomfort, Headache, Cerebrovascular Accident, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apresoline
    Dosage: 1 df, daily.
    Indication: Cardiac Disorder

Diovan HCT
    Dosage: 2 df, daily

Other drugs received by patient: Lotigrel



Possible Apresoline side effects in 57 year old female

Reported by a consumer/non-health professional from Brazil on 2012-05-30

Patient: 57 year old female

Reactions: Blood Pressure Increased, Head Discomfort, Headache, Cerebrovascular Accident, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apresoline
    Dosage: 1 df, daily.
    Indication: Cardiac Disorder

Diovan HCT
    Dosage: 2 df, daily

Other drugs received by patient: Lotigrel



Possible Apresoline side effects in 57 year old female

Reported by a consumer/non-health professional from Brazil on 2012-05-25

Patient: 57 year old female

Reactions: Blood Pressure Increased, Headache, Cerebrovascular Accident, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan HCT
    Dosage: 320/12.5mg
    Administration route: Oral

Apresoline
    Dosage: 50 mg, unk
    Administration route: Oral

Other drugs received by patient: Lotigrel



Possible Apresoline side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-05-08

Patient: female

Reactions: Renal Failure, Diabetes Mellitus, Hypertension, Cardiac Disorder

Drug(s) suspected as cause:
Calcium

Apresoline

Rasilez

Other drugs received by patient: Carvedilol; Artoglico; Topiramate; Furosemide; NPH Insulin; Gabapentin; Trajenta; Artovastatin; Citalopram Hydrobromide; Aspirin; Insulin; Pantoprazole; Aetropotina; Etna



Possible Apresoline side effects in 32 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-03

Patient: 32 year old female, weighing 63.0 kg (138.6 pounds)

Reactions: Chorioamnionitis, Maternal Exposure During Pregnancy, Foetal Disorder, Gestational Hypertension, Renal Impairment, Proteinuria, Oedema, Premature Delivery, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apresoline
    Dosage: 6 mg, (injection), unk

Cyclosporine
    Dosage: 200 mg, daily
    Administration route: Oral
    Indication: Aplastic Anaemia

Apresoline
    Dosage: unk ukn, unk
    Administration route: Oral
    Indication: Blood Pressure

Other drugs received by patient: Prednisolone; Fentanyl; Propofol; Rocuronium Bromide; Midazolam; Nicardipine HCL



Possible Apresoline side effects in

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-05-03

Patient:

Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy, Foetal Disorder, Foetal Distress Syndrome, Foetal Growth Restriction, Respiratory Disorder Neonatal, Developmental Delay

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclosporine
    Dosage: maternal dose: 200 mgdaily

Apresoline
    Dosage: maternal dose unknown, oral
    Indication: Blood Pressure

Apresoline
    Dosage: maternal dose 6mg, intravenous

Other drugs received by patient: Prednisolone



Possible Apresoline side effects in male

Reported by a physician from Brazil on 2012-04-26

Patient: male, weighing 2.8 kg (6.2 pounds)

Reactions: Premature Baby, Foetal Exposure During Pregnancy, Convulsion, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apresoline

Diovan HCT
    Dosage: 1 df,qd

Other drugs received by patient: Aldomet; Yasmin



Possible Apresoline side effects in female

Reported by a physician from Brazil on 2012-04-25

Patient: female

Reactions: Blood Pressure Increased, Diabetes Mellitus, Maternal Exposure During Pregnancy, Premature Delivery

Drug(s) suspected as cause:
Apresoline

Diovan HCT
    Dosage: one tablet daily
    Indication: Hypertension

Diovan HCT
    Dosage: 160/12.5 mg, unk daily dose
    Start date: 2012-02-14

Other drugs received by patient: Yasmin; Aldomet



Possible Apresoline side effects in 41 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-19

Patient: 41 year old female, weighing 62.0 kg (136.4 pounds)

Reactions: Specific Gravity Urine Decreased, Maternal Exposure During Pregnancy, Blood Chloride Increased, Hypernatraemia, Premature Labour, Urine Output Increased, Hyposthenuria, Dehydration, Gestational Diabetes, Blood Creatinine Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Apresoline
    Dosage: 30 mg per day
    Administration route: Oral
    Indication: Gestational Hypertension

Apresoline
    Dosage: 120 mg per day
    Administration route: Oral

Methyldopa
    Dosage: 750 mg, per day

Other drugs received by patient: Ritodrine Hydrochloride; Flomoxef Sodium



Possible Apresoline side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-04-19

Patient: male

Reactions: LOW Birth Weight Baby, Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Apresoline
    Dosage: maternal dose 30 mg

Apresoline
    Dosage: maternal dose of 120 mg

Methyldopa
    Dosage: (maternal dose of 750 mg per day)

Other drugs received by patient: Ritodrine Hydrochloride; Flomoxef Sodium



Possible Apresoline side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-02-22

Patient: male, weighing 2.8 kg (6.2 pounds)

Reactions: Premature Baby, Foetal Exposure During Pregnancy, Convulsion, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diovan HCT
    Dosage: maternal dose: 160/12.5 mg, one tablet daily

Apresoline
    Dosage: maternal dose: 500 mg, unk

Other drugs received by patient: Yasmin; Aldomet



Possible Apresoline side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-02-21

Patient: female

Reactions: Blood Pressure Increased, Diabetes Mellitus, Maternal Exposure During Pregnancy, Premature Delivery

Drug(s) suspected as cause:
Diovan HCT
    Dosage: one tablet daily
    Indication: Hypertension

Diovan HCT
    Dosage: 160/12.5 mg, unk

Apresoline
    Dosage: 50 mg, unk

Other drugs received by patient: Aldomet; Yasmin



Possible Apresoline side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-01-19

Patient: male

Reactions: Emotional Disorder, Hypertension

Drug(s) suspected as cause:
Apresoline
    Dosage: 3 df, qd
    Indication: Hypertension

Exforge
    Dosage: 1 df, qd
    Indication: Hypertension

Other drugs received by patient: Isosorbide Mononitrate; Diazepam; Furosemide; Atenolol; Clonazepam; Simvastatin



Possible Apresoline side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-01-05

Patient: male

Reactions: Blood Pressure Increased, Wrong Technique in Drug Usage Process, Fear, Feeling Abnormal

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Atenolol
    Dosage: 1 df in the morning

Apresoline
    Dosage: 1 tablet in the morning and 1 tablet at night

Apresoline
    Dosage: 50 mg, half tablet

Apresoline
    Dosage: 1 df in the night

Losartan Potassium
    Dosage: 1 df in the morning

Atenolol
    Dosage: 1 df in the afternoon

Other drugs received by patient: Indapen; Simvastatin; Aspirin



Possible Apresoline side effects in male

Reported by a individual with unspecified qualification from Brazil on 2011-12-28

Patient: male

Reactions: Emotional Disorder, Hypertension, Infarction

Drug(s) suspected as cause:
Apresoline
    Dosage: 3 df, qd
    Indication: Hypertension

Exforge
    Dosage: 1 df, qd
    Indication: Hypertension



Possible Apresoline side effects in male

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-12-19

Patient: male

Reactions: LOW Birth Weight Baby, Renal Hypoplasia, Foetal Growth Restriction, Premature Baby, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Methyldopa

Apresoline

Trichlormethiazide



Possible Apresoline side effects in female

Reported by a individual with unspecified qualification from Brazil on 2011-12-02

Patient: female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Exforge
    Dosage: 160/5 mg; unk
    Administration route: Oral

Apresoline
    Dosage: 25 mg, unk

Other drugs received by patient: Simvastatin; Amiodarone HCL



Possible Apresoline side effects in 35 year old female

Reported by a health professional (non-physician/pharmacist) from Taiwan, Province of China on 2011-11-21

Patient: 35 year old female, weighing 65.0 kg (143.0 pounds)

Reactions: Phaeochromocytoma, NO Therapeutic Response, Tachycardia, Circulatory Collapse, Ventricular Fibrillation, Loss of Consciousness

Adverse event resulted in: death

Drug(s) suspected as cause:
Labetalol Hydrochloride
    Dosage: 35 mg; iv
    Indication: Hypertension

Nicardipine HCL
    Dosage: 2 mg; iv
    Indication: Hypertension

Apresoline
    Dosage: 10 mg; iv
    Indication: Hypertension

Other drugs received by patient: Acebutolol; Methyldopa



Possible Apresoline side effects in male

Reported by a individual with unspecified qualification from United Kingdom on 2011-11-08

Patient: male, weighing 66.0 kg (145.2 pounds)

Reactions: Acute Pulmonary Oedema, Wrong Technique in Drug Usage Process, Renal Disorder, Vascular Occlusion, Erythema, Cardiac Disorder, Blood Uric Acid Increased, Oedema Peripheral, Hypertension, Feeling Abnormal, Muscle Spasms, Cough, Blood Pressure Diastolic Decreased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Apresoline
    Dosage: 1 df (50 mg) per day
    Administration route: Oral

Rasilez
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-04-01

Apresoline
    Dosage: 2 df (25 mg) per day
    Administration route: Oral

Apresoline
    Dosage: 2 df (50 mg) per day
    Administration route: Oral

Apresoline
    Dosage: 1 df (25 mg) per day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2006-01-01

Apresoline
    Dosage: 3 df (50 mg) per day
    Administration route: Oral

Apresoline
    Dosage: 1 df (25 mg) bid

Apresoline
    Dosage: 50 mg, 0.5 tablet, both morning and night

Other drugs received by patient: Epogen; Citoneurin; Folic Acid; Lipitor; Lasix



Possible Apresoline side effects in 60 year old male

Reported by a individual with unspecified qualification from United Kingdom on 2011-10-28

Patient: 60 year old male

Reactions: Movement Disorder, Wrong Technique in Drug Usage Process, Pneumonia, Urinary Tract Infection, Cerebrovascular Accident, Prostatic Disorder, Nosocomial Infection, Lung Disorder, Urinary Tract Infection Bacterial, Prostatomegaly, Urinary Retention, Infarction

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Apresoline
    Dosage: 25 mg, tid
    Indication: Hypertension

Apresoline
    Dosage: 50 mg (half tablets 3 times/day)

Diovan
    Dosage: 1 df, bid
    Indication: Hypertension

Other drugs received by patient: Amlodipine; Seroquel; Clonidine Hydrochloride; Enalapril Maleate; Aspirin; Lipitor; Macrodantin



Possible Apresoline side effects in 35 year old female

Reported by a individual with unspecified qualification from Japan on 2011-10-06

Patient: 35 year old female, weighing 64.0 kg (140.8 pounds)

Reactions: Phaeochromocytoma, Drug Ineffective, Maternal Exposure During Pregnancy, Tachycardia, Loss of Consciousness, Hypertensive Crisis, Circulatory Collapse, Ventricular Fibrillation

Adverse event resulted in: death

Drug(s) suspected as cause:
Labetalol HCL
    Dosage: 35 mg, unk
    Indication: Hypertensive Crisis

Apresoline
    Dosage: 10 mg, unk

Apresoline
    Dosage: 5 mg, unk

Nicardipine HCL
    Dosage: 1 mg, unk
    Indication: Hypertension

Nicardipine HCL
    Dosage: 2 mg, unk

Other drugs received by patient: Dopamine HCL



Possible Apresoline side effects in 60 year old male

Reported by a consumer/non-health professional from Brazil on 2011-10-03

Patient: 60 year old male

Reactions: Movement Disorder, Wrong Technique in Drug Usage Process, Lung Disorder, Urinary Tract Infection, Cerebrovascular Accident, Prostatic Disorder

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Diovan
    Dosage: 1 df, bid
    Indication: Hypertension

Apresoline
    Dosage: 50 mg (half tablets 3 times/day)

Apresoline
    Dosage: 25 mg, tid
    Indication: Hypertension

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