Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reactions (≥ 5% more on isosorbide dinitrate and hydralazine hydrochloride tablets than on placebo) were headache and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Wilshire Pharmaceuticals, Inc.
at 1-877-495-6856 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Isosorbide dinitrate and hydralazine hydrochloride tablets have been evaluated for safety in 517 heart failure patients in A-HeFT.
A total of 317 of these patients received isosorbide dinitrate and hydralazine hydrochloride tablets for at least 6 months, and 220 received isosorbide dinitrate and hydralazine hydrochloride tablets for at least 12 months.
In A-HeFT, 21% of the patients discontinued isosorbide dinitrate and hydralazine hydrochloride tablets for adverse reactions compared to 12% who discontinued placebo.
Overall, adverse reactions were more common in isosorbide dinitrate and hydralazine hydrochloride tablets-treated than in placebo-treated patients.
Table 1 lists adverse reactions reported with an incidence, after rounding, ≥ 2% higher on isosorbide dinitrate and hydralazine hydrochloride tablets than on placebo in A-HeFT, regardless of causality.
The most common reasons for discontinuing isosorbide dinitrate and hydralazine hydrochloride tablets in the A-HeFT trial was headache (7%).
Adverse Reactions Occurring in the A-HeFT Study in ≥ 2% of Patients Treated with isosorbide dinitrate and hydralazine hydrochloride tablets.
5 WARNINGS AND PRECAUTIONS May cause symptomatic hypotension ( 5.1 ) Symptomatic Lupus Erythematosus Syndromes: Consider discontinuation if clinically appropriate ( 5.2 ) Myocardial ischemia and angina ( 5.3 ) Peripheral Neuritis: May be treated with Pyridoxine ( 5.4 ) 5.1 Hypotension Symptomatic hypotension, particularly with upright posture, may occur with even small doses of isosorbide dinitrate and hydralazine hydrochloride tablets.
Hypotension is most likely to occur in patients who have been volume or salt depleted;
correct prior to initiation of isosorbide dinitrate and hydralazine hydrochloride tablets [see Adverse Reactions (6.1) ] .
5.2 Systemic Lupus Erythematosus Hydralazine hydrochloride has been reported to cause a drug-induced systemic lupus erythematosus (SLE) syndrome.
Symptoms and signs usually regress when hydralazine hydrochloride is discontinued.
Like all medications, Isosorbide Dinitrate And Hydralazine Hydrochloride can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: