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 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 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 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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