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Minitran (Nitroglycerin Transdermal) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Minitran (Nitroglycerin Transdermal) 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 (15)
Death (1)
Life Threatening Events (1)

Reports by Reaction Type

Hypotension (6)Bradycardia (3)Drug Hypersensitivity (2)Syncope (2)Product Substitution Issue (1)Bradyarrhythmia (1)Fall (1)Skin Ulcer (1)Coronary Artery Occlusion (1)Posterior Reversible Encephalopathy Syndrome (1)Dizziness (1)Subcutaneous Abscess (1)

Possible Minitran side effects in 42 year old male

Reported by a physician from United States on 2012-04-20

Patient: 42 year old male

Reactions: Coronary Artery Occlusion, General Physical Health Deterioration, Ventricular Fibrillation, Cardiac Arrest

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Minitran
    Dosage: x1;sl
    Indication: Myocardial Infarction

Minitran
    Dosage: x1;sl
    Indication: Blood Pressure Increased



Possible Minitran side effects in 51 year old male

Reported by a health professional (non-physician/pharmacist) from Luxembourg on 2012-04-20

Patient: 51 year old male

Reactions: Posterior Reversible Encephalopathy Syndrome

Drug(s) suspected as cause:
Minitran
    Dosage: x1;top
    Administration route: Topical
    Indication: Cardiac Disorder

Minitran
    Dosage: x1;top
    Administration route: Topical
    Indication: Muscle Strain



Possible Minitran side effects in female

Reported by a physician from Canada on 2012-04-19

Patient: female

Reactions: Cerebrovascular Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Minitran



Possible Minitran side effects in 81 year old female

Reported by a physician from Italy on 2012-04-03

Patient: 81 year old female

Reactions: Syncope, Bradyarrhythmia, Atrial Fibrillation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rivastigime Tartrate
    Dosage: (1 dosage forms, 1 d), oral
    Administration route: Oral
    Indication: Dementia Alzheimer's Type
    Start date: 2010-01-01
    End date: 2012-03-06

Minitran
    Dosage: (1 dosage forms, 1 d0, transdermal
    Indication: Myocardial Ischaemia
    Start date: 2010-01-01
    End date: 2012-03-06

Ramipril
    Dosage: (1 dosage forms), oral
    Administration route: Oral
    Indication: Hypertension

Escitalopram Oxalate
    Dosage: (1 dosage forms), oral
    Administration route: Oral
    Indication: Depression

Amlodipine Besylate
    Dosage: (1 dosage forms), oral
    Administration route: Oral
    Indication: Myocardial Ischaemia

Aspirin
    Dosage: 91 dosage forms), oral
    Administration route: Oral
    Indication: Cardiovascular Event Prophylaxis

Atenolol
    Dosage: (100 mg, 1 d), oral
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2010-01-01
    End date: 2012-03-06



Possible Minitran side effects in female

Reported by a physician from United States on 2012-03-23

Patient: female, weighing 52.2 kg (114.7 pounds)

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Codeine
    Dosage: unk

Gemfibrozil
    Dosage: unk

Timoptic
    Dosage: unk

Minitran
    Dosage: unk

Ergomar
    Dosage: unk

Alphagan
    Dosage: unk

Celexa
    Dosage: unk

Velocef
    Dosage: unk

Tobramycin
    Dosage: unk

Valium
    Dosage: unk

Phenergan HCL
    Dosage: unk

E.E.S.
    Dosage: unk

Tetanus Toxoid
    Dosage: unk

Ciprofloxacin
    Dosage: unk

Azopt
    Dosage: unk

Lipitor
    Dosage: unk

Vicodin
    Dosage: unk

Darvon
    Dosage: unk



Possible Minitran side effects in female

Reported by a physician from United States on 2012-03-23

Patient: female, weighing 52.2 kg (114.7 pounds)

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Timoptic
    Dosage: unk

Phenergan
    Dosage: unk

E.E.S.
    Dosage: unk

Lipitor
    Dosage: unk

Minitran
    Dosage: unk

Celexa
    Dosage: unk

Tetanus Toxoid
    Dosage: unk

Valium
    Dosage: unk

Darvon
    Dosage: unk

Ergomar
    Dosage: unk

Azopt
    Dosage: unk

Vicodin
    Dosage: unk

Alphagan
    Dosage: unk

Tetracycline HCL
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Gemfibrozil
    Dosage: unk

Ciprofloxacin
    Dosage: unk

Velocef
    Dosage: unk



Possible Minitran side effects in 84 year old female

Reported by a physician from Italy on 2012-03-13

Patient: 84 year old female

Reactions: Syncope, Bradycardia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Minitran
    Dosage: 2 df/day
    Administration route: Oral
    Indication: Myocardial Ischaemia
    Start date: 2010-01-01
    End date: 2011-11-30

Carvedilol
    Dosage: 1 df, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2010-01-01
    End date: 2011-11-30

Ramipril
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01
    End date: 2011-11-30

Ramipril
    Dosage: 2.5 mg, unk

Ramipril
    Dosage: 1.5 mg, unk

Lasix
    Dosage: 0.5 df, 1x/day
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-09-01
    End date: 2011-11-30

Other drugs received by patient: Aspirin; Fosavance; Pantoprazole



Possible Minitran side effects in 87 year old female

Reported by a physician from Italy on 2012-03-05

Patient: 87 year old female

Reactions: Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Revatio
    Dosage: 2 unit dose daily
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2008-04-28

Ramipril
    Dosage: 1.25 mg daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2005-01-01
    End date: 2012-01-16

Lasix
    Dosage: 50 mg daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-01-01
    End date: 2012-01-16

Minitran
    Dosage: 10 mg, daily
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-01-01

Aldactone
    Dosage: 50 mg daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2005-01-01

Other drugs received by patient: Coumadin; Nexium; Aliflus Diskus; Tapazole; Spiriva; Bisoprolol Fumarate



Possible Minitran side effects in 87 year old female

Reported by a physician from Italy on 2012-02-24

Patient: 87 year old female

Reactions: Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ramipril
    Dosage: 1.25 mg daily
    Administration route: Oral
    Indication: Hypertension
    Start date: 2005-01-01
    End date: 2012-01-16

Revatio
    Dosage: 2 unit dose daily
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2008-04-28

Aldactone
    Dosage: 50 mg daily
    Administration route: Oral
    Start date: 2005-01-01

Minitran
    Dosage: 10 mg, daily
    Start date: 2005-01-01

Lasix
    Dosage: 50 mg daily
    Administration route: Oral
    Start date: 2005-01-01
    End date: 2012-01-16

Other drugs received by patient: Aliflus Diskus; Bisoprolol Fumarate; Tapazole; Coumadin; Nexium; Spiriva



Possible Minitran side effects in 87 year old female

Reported by a physician from Italy on 2012-02-22

Patient: 87 year old female

Reactions: Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aldactone
    Dosage: 50 mg daily
    Administration route: Oral
    Start date: 2005-01-01

Ramipril
    Dosage: 1.25 mg daily
    Administration route: Oral
    Start date: 2005-01-01
    End date: 2012-01-16

Lasix
    Dosage: 50 mg daily
    Administration route: Oral
    Start date: 2005-01-01
    End date: 2012-01-16

Revatio
    Dosage: 2 unit dose daily
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2008-04-28

Minitran
    Dosage: 10 mg, daily
    Start date: 2005-01-01

Other drugs received by patient: Tapazole; Nexium; Bisoprolol Fumarate; Aliflus Diskus; Spiriva; Coumadin



Possible Minitran side effects in 87 year old female

Reported by a physician from Italy on 2012-02-14

Patient: 87 year old female

Reactions: Hypotension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Minitran
    Dosage: 1 unit dose daily
    Start date: 2005-01-01

Aldactone
    Dosage: 50 mg daily
    Administration route: Oral
    Start date: 2005-01-01

Lasix
    Dosage: 50 mg, 1x/day
    Administration route: Oral
    Start date: 2005-01-01
    End date: 2012-01-16

Ramipril
    Dosage: 1.25 mg daily
    Administration route: Oral
    Start date: 2005-01-01
    End date: 2012-01-16

Revatio
    Dosage: 2 unit dose daily
    Administration route: Oral
    Indication: Pulmonary Hypertension
    Start date: 2008-04-28

Other drugs received by patient: Tapazole; Spiriva; Nexium; Aliflus Diskus; Bisoprolol Fumarate; Coumadin



Possible Minitran side effects in 75 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-01

Patient: 75 year old female

Reactions: Skin Graft, Skin Ulcer, Subcutaneous Abscess, Sepsis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Minitran
    Dosage: 0.4 mg;hs;tder ; 0.6 mg;hs;tder
    Indication: Angina Pectoris

Minitran
    Dosage: 0.4 mg;hs;tder ; 0.6 mg;hs;tder
    Indication: Myocardial Infarction



Possible Minitran side effects in male

Reported by a individual with unspecified qualification from Italy on 2011-10-21

Patient: male

Reactions: Hypotension, Bradycardia

Drug(s) suspected as cause:
Minitran
    Dosage: 15 mg, daily
    Start date: 2010-07-31
    End date: 2011-07-30

Valsartan and Hydrochlorothiazide
    Dosage: unk ukn, unk
    Administration route: Oral
    Start date: 2010-07-31
    End date: 2011-07-30

Lopressor
    Dosage: 150 mg, daily
    Administration route: Oral
    Start date: 2010-07-31
    End date: 2011-07-30

Cordarone
    Dosage: 200 mg, daily
    Administration route: Oral
    Start date: 2010-07-31
    End date: 2011-07-30

Other drugs received by patient: Levothyroxine Sodium; Dramion; Metformin HCL; Metoprolol Tartrate; Gliclazide; Glyceryl Trinitrate; Aspirin; Amiodarone HCL



Possible Minitran side effects in male

Reported by a individual with unspecified qualification from Italy on 2011-10-07

Patient: male

Reactions: Hypotension, Bradycardia

Drug(s) suspected as cause:
Valsartan and Hydrochlorothiazide
    Dosage: unk ukn, unk
    Start date: 2010-07-31
    End date: 2011-07-30

Minitran
    Dosage: 15 mg, unk
    Start date: 2010-07-31
    End date: 2011-07-30

Cordarone
    Dosage: 200 mg, unk
    Administration route: Oral
    Start date: 2010-07-31
    End date: 2011-07-30

Lopressor
    Dosage: 150 mg, daily
    Administration route: Oral
    Start date: 2010-07-31
    End date: 2011-07-30

Other drugs received by patient: Metformin Hydrochloride; Amiodarone HCL; Dramion; Metoprolol Tartrate; Levothyroxine Sodium; Glyceryl Trinitrate; Aspirin; Gliclazide



Possible Minitran side effects in 64 year old male

Reported by a individual with unspecified qualification from United States on 2011-10-07

Patient: 64 year old male, weighing 108.0 kg (237.5 pounds)

Reactions: Product Substitution Issue, Depressed Level of Consciousness, Dizziness, Vertigo, Fall

Drug(s) suspected as cause:
Minitran

Other drugs received by patient: Nitroglycerin

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