Minitran (Nitroglycerin Transdermal) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Adverse reactions to nitroglycerin are generally dose-related, and almost all of these reactions are the result of nitroglycerin's activity as a vasodilator. Headache, which may be severe, is the most commonly reported side effect. Headache may be recurrent with each daily dose, especially at higher doses. Transient episodes of lightheadedness, occasionally related to blood pressure changes, may also occur. Hypotension occurs infrequently, but in some patients it may be severe enough to warrant discontinuation of therapy. Syncope, crescendo angina, and rebound hypertension have been reported but are uncommon.

Extremely rarely, ordinary doses of organic nitrates have caused methemoglobinemia in normal-seeming patients. Methemoglobinemia is so infrequent at these doses that further discussion of its diagnosis and treatment is deferred (see OVERDOSAGE).

Allergic reactions to nitroglycerin are also uncommon, and the great majority of those reported have been cases of contact dermatitis or fixed drug eruptions in patients receiving nitroglycerin in ointments or patches. There have been a few reports of genuine anaphylactoid reactions, and these reactions can probably occur in patients receiving nitroglycerin by any route.

In two placebo-controlled trials of intermittent therapy with nitroglycerin patches at 0.2 to 0.8 mg/hr, the most frequent adverse reactions among 307 subjects were as follows:

	placebo	patch
headache	18%	63%
lightheadedness	4%	6%
hypotension and/or syncope	0%	4%
increased angina	2%	2%

REPORTS OF SUSPECTED MINITRAN SIDE EFFECTS / ADVERSE REACTIONS

Possible Minitran side effects / adverse reactions 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

Suspect drug(s):
Minitran

Other drugs received by patient: Nitroglycerin

Possible Minitran side effects / adverse reactions 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

Suspect drug(s):
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 / adverse reactions 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

Suspect drug(s):
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