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 Quinapril and Hydrochlorothiazide Tablets has been evaluated for safety in 1571 patients in controlled and uncontrolled studies.
Of these, 498 were given quinapril plus hydrochlorothiazide for at least 1 year, with 153 patients extending combination therapy for over 2 years.
In clinical trials with Quinapril and Hydrochlorothiazide Tablets, no adverse experience specific to the combination has been observed.
Adverse experiences that have occurred have been limited to those that have been previously reported with quinapril or hydrochlorothiazide.
Adverse experiences were usually mild and transient, and there was no relationship between side effects and age, sex, race, or duration of therapy.
Discontinuation of therapy because of adverse effects was required in 2.1% in patients in controlled studies.
The most common reasons for discontinuation of therapy with Quinapril and Hydrochlorothiazide Tablets were cough (1.0%;
see PRECAUTIONS ) and headache (0.7%).
Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 943 patients treated with quinapril plus hydrochlorothiazide in controlled trials are shown below.
Percent of Patients in Controlled Trials Quinapril/HCTZ N = 943 Placebo N = 100 Headache 6.7 30.0 Dizziness 4.8 4.0 Coughing 3.2 2.0 Fatigue 2.9 3.0 Myalgia 2.4 5.0 Viral Infection 1.9 4.0 Rhinitis 2.0 3.0 Nausea and/or Vomiting 1.8 6.0 Abdominal Pain 1.7 4.0 Back Pain 1.5 2.0 Diarrhea 1.4 1.0 Upper Respiratory Infection 1.3 4.0 Insomnia 1.2 2.0 Somnolence 1.2 0.0 Bronchitis 1.2 1.0 Dyspepsia 1.2 2.0 Asthenia 1.1 1.0 Pharyngitis 1.1 2.0 Vasodilatation 1.0 1.0 Vertigo 1.0 2.0 Chest Pain 1.0 2.0 Clinical adverse experiences probably, possibly, or definitely related or of uncertain relationship to therapy occurring in ≥0.5% to <1.0% (except as noted) of the patients treated with quinapril/HCTZ in controlled and uncontrolled trials (N=1571) and less frequent, clinically significant events seen in clinical trials or postmarketing experience (the rarer events are in italics) include (listed by body system): BODY AS A WHOLE: Asthenia, Malaise CARDIOVASCULAR: Palpitation, Tachycardia, Heart Failure, Hyperkalemia, Myocardial Infarction, Cerebrovascular Accident, Hypertensive Crisis, Angina Pectoris, Orthostatic Hypotension, Cardiac Rhythm Disturbance GASTROINTESTINAL: Mouth or Throat Dry, Gastrointestinal Hemorrhage, Pancreatitis, Abnormal Liver Function Tests NERVOUS/PSYCHIATRIC: Nervousness, Vertigo, Paresthesia RESPIRATORY: Sinusitis, Dyspnea INTEGUMENTARY: Pruritus, Sweating Increased, Erythema Multiforme, Exfoliative Dermatitis, Photosensitivity Reaction, Alopecia, Pemphigus UROGENITAL SYSTEM: Acute Renal Failure, Impotence OTHER: Agranulocytosis, Thrombocytopenia, Arthralgia Angioedema: Angioedema has been reported in 0.1% of patients receiving quinapril (0.1%) (see WARNINGS ).
WARNINGS Anaphylactoid and Possibly Related Reactions: Presumably because angiotensin converting inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including quinapril) 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 ACE inhibitors and has been seen in 0.1% of patients receiving quinapril.
In two similarly sized US postmarketing quinapril trials that, combined, enrolled over 3,000 black patients and over 19,000 non-blacks, angioedema was reported in 0.30% and 0.55% of blacks (in Study 1 and 2, respectively) and 0.39% and 0.17% of non-blacks.
Angioedema associated with laryngeal edema can be fatal.
If laryngeal stridor or angioedema of the face, tongue, or glottis occurs, treatment with Quinapril and Hydrochlorothiazide Tablets should be discontinued immediately, the patient treated in accordance with accepted medical care, and carefully observed until the swelling disappears.
Like all medications, Quinapril Hcl 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: