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BiDil

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BiDil

SIDE EFFECTS

BiDil (isosorbide dinitrate and hydralazine hcl)

BiDil (isosorbide dinitrate and hydralazine hcl) has been evaluated for safety in 517 heart failure patients in A-HeFT. A total of 317 of these patients received BiDil (isosorbide dinitrate and hydralazine hcl) for at least 6 months,and 220 received BiDil (isosorbide dinitrate and hydralazine hcl) for at least 12 months. In A-HeFT, 21% of the patients discontinued BiDil (isosorbide dinitrate and hydralazine hcl) for adverse experiences compared to 12% who discontinued placebo.Overall, adverse events were more common in BiDil (isosorbide dinitrate and hydralazine hcl) -treated than in placebo-treated patients. Table 2 lists adverse events reported with an incidence of ≥ 2% in patients treated with BiDil (isosorbide dinitrate and hydralazine hcl) in A-HeFT,and,after rounding to the nearest 1%, occurring more frequently than in the placebo group,regardless of causality. Headache and dizziness were the two most frequent adverse events and were more than twice as frequent in the BiDil (isosorbide dinitrate and hydralazine hcl) group. The most common reasons for discontinuing BiDil (isosorbide dinitrate and hydralazine hcl) in the A-HeFT trial were headache (7%) and dizziness (4%).

Table 2. Adverse Events Occurring in the A-HeFT Study in ≥ 2% of Patients Treated with BiDil (isosorbide dinitrate and hydralazine hcl) .

  BiDil (isosorbide dinitrate and hydralazine hcl)
(N=517)
(% of patients)
Placebo
(N=527)
(% of patients)
Headache 50 21
Dizziness 32 14
Chest pain 16 15
Asthenia 14 11
Nausea 10 6
Bronchitis 8 7
Hypotension 8 4
Sinusitis 4 2
Ventricular tachycardia 4 2
Palpitations 4 3
Hyperglycemia 4 3
Rhinitis 4 3
Paresthesia 4 2
Vomiting 4 2
Amblyopia 3 1
Hyperlipidemia 3 2
Tachycardia 2 1

The following adverse events were reported in A-HeFT in at least 1% but less than 2% of patients treated with BiDil (isosorbide dinitrate and hydralazine hcl) , and also occurred in at least 0.5% more patients than in placebo-treated patients; all such events are included unless they are too non-specific to be meaningful or appear to reflect underlying disease.

Body as a Whole: Allergic reaction,malaise.

Central nervous system: Somnolence.

Gastrointestinal: Cholecystitis.

Metabolic: Hypercholesteremia.

Musculoskeletal: Arthralgia,myalgia, tendon disorder.

Skin:Alopecia,angioedema,sweating.

In the V-HeFT I and II studies,a total of 587 patients with heart failure were treat-ed with the combination of isosorbide dinitrate and hydralazine hydrochloride. The type,pattern,frequency and severity of adverse experiences reported in these studies were similar to those reported in A-HeFT,and no unusual adverse experiences were reported.

Prior experience with BiDil (isosorbide dinitrate and hydralazine hcl) components

The following additional adverse events have been reported with hydralazine hydrochloride or isosorbide dinitrate but not necessarily with BiDil (isosorbide dinitrate and hydralazine hcl) :

Digestive: paralytic ileus.

Cardiovascular: paradoxical pressor response, crescendo angina.

Neurologic: peripheral neuritis, numbness,tingling, muscle cramps, psychotic reactions,disorientation.

Genitourinary: difficulty in urination.

Hematologic: blood dyscrasias,agranulocytosis,purpura,splenomegaly.

Hypersensitive Reactions: eosinophilia,hepatitis.

Other: nasal congestion,flushing,lacrimation,conjunctivitis.

Read the BiDil (isosorbide dinitrate and hydralazine hcl) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drug/Drug Interactions

Due to the hydralazine component of BiDil (isosorbide dinitrate and hydralazine hcl) ,monoamine-oxidase inhibitors should be used with caution in patients receiving BiDil (isosorbide dinitrate and hydralazine hcl) .

Patients treated with BiDil (isosorbide dinitrate and hydralazine hcl) who receive any potent parenteral antihypertensive agent should be continuously observed for several hours for excessive fall in blood pressure.

The effects of BiDil (isosorbide dinitrate and hydralazine hcl) on vasodilators including alcohol may be additive.

Sildenafil: See WARNINGS.

Vardenafil: See WARNINGS.

Tadalafil: See WARNINGS.

Read the BiDil Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 10/7/2008
This monograph has been modified to include the generic and brand name in many instances.

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BiDil - User Reviews

BiDil User Reviews

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