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.
ADVERSE REACTIONS Fosinopril sodium and hydrochlorothiazide tablets have been evaluated for safety in over 660 patients with hypertension;
approximately 137 of these patients were treated for more than one year.
The observed adverse events were generally mild, transient, and similar to those seen with fosinopril and hydrochlorothiazide taken separately.
There was no relationship between the incidence of side effects and age.
In placebo-controlled clinical trials of fosinopril sodium and hydrochlorothiazide, the usual duration of therapy was two months.
Adverse clinical or laboratory events led to discontinuation of therapy by 4.3% of 368 placebo-treated patients and by 3.5% of 660 fosinopril sodium and hydrochlorothiazide-treated patients.
The most common reasons for discontinuation of therapy with fosinopril sodium and hydrochlorothiazide in U.S.
studies were headache (0.3%), cough (0.3%;
see PRECAUTIONS ), and fatigue (0.2%).
The side effects considered probably or possibly related to study drug that occurred in placebo-controlled trials in more than 2% of patients treated with fosinopril sodium and hydrochlorothiazide are shown in the table below.
WARNINGS Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including fosinopril sodium and hydrochlorothiazide) may be subject to a variety of adverse reactions, some of them serious.
Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis, and larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors.
Angioedema associated with laryngeal edema can be fatal.
If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, treatment with fosinopril sodium and hydrochlorothiazide should be discontinued and appropriate therapy instituted immediately.
When involvement of the tongue, glottis, or larynx appears likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine injection 1:1000 (0.3 to 0.5 mL) should be promptly administered (see PRECAUTIONS and ADVERSE REACTIONS ).
Like all medications, Fosinopril Sodium And Hydrochlorothiazide 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: