ACCURETIC 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 ACCURETIC, 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 ACCURETIC 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
N = 943
N = 100
|Nausea and/or Vomiting
|Upper Respiratory Infection
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
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,
UROGENITAL SYSTEM: Acute Renal Failure,
OTHER: Agranulocytosis, Thrombocytopenia,
Angioedema: Angioedema has been reported in 0.1%
of patients receiving quinapril (0.1%) (see WARNINGS).
The following serious nonfatal
adverse events, regardless of their relationship to quinapril and HCTZ
combination tablets, have been reported during extensive postmarketing
BODY AS A WHOLE: Shock, accidental injury, neoplasm, cellulitis, ascites,
generalized edema, hernia and anaphylactoid reaction.
CARDIOVASCULAR SYSTEM: Bradycardia, cor pulmonale, vasculitis, and deep
DIGESTIVE SYSTEM: Gastrointestinal carcinoma,
cholestatic jaundice, hepatitis, esophagitis, vomiting, and diarrhea.
EYE DISORDERS: Acute myopia and acute angle
closure glaucoma (see WARNINGS).
HEMIC SYSTEM: Anemia.
METABOLIC AND NUTRITIONAL DISORDERS: Weight loss.
MUSCULOSKELETAL SYSTEM: Myopathy, myositis, and
NERVOUS SYSTEM: Paralysis, hemiplegia, speech
disorder, abnormal gait, meningism, and amnesia.
RESPIRATORY SYSTEM: Pneumonia, asthma, respiratory
infiltration, and lung disorder.
SKIN AND APPENDAGES: Urticaria, macropapular rash,
SPECIAL SENSES: Abnormal vision.
UROGENITAL SYSTEM: Kidney function abnormal,
albuminuria, pyuria, hematuria, and nephrosis.
Quinapril monotherapy has been evaluated for safety in
4960 patients. In clinical trials adverse events which occurred with quinapril
were also seen with ACCURETIC. In addition, the following were reported for
quinapril at an incidence > 0.5%: depression, back pain, constipation,
syncope, and amblyopia.
Hydrochlorothiazide has been extensively prescribed for
many years, but there has not been enough systematic collection of data to
support an estimate of the frequency of the observed adverse reactions. Within
organ-system groups, the reported reactions are listed here in decreasing order
of severity, without regard to frequency.
BODY AS A WHOLE: Weakness.
CARDIOVASCULAR: Orthostatic hypotension (may be potentiated by alcohol,
barbiturates, or narcotics).
DIGESTIVE: Pancreatitis, jaundice (intrahepatic cholestatic), sialadenitis,
vomiting, diarrhea, cramping, nausea, gastric irritation, constipation, and
NEUROLOGIC: Vertigo, lightheadedness, transient blurred vision, headache,
paresthesia, xanthopsia, weakness, and restlessness.
MUSCULOSKELETAL: Muscle spasm.
HEMATOLOGIC: Aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia,
and hemolytic anemia.
failure, renal dysfunction, interstitial nephritis (see WARNINGS).
METABOLIC: Hyperglycemia, glycosuria, and hyperuricemia.
HYPERSENSITIVITY: Necrotizing angiitis, Stevens-Johnson syndrome, respiratory
distress (including pneumonitis and pulmonary edema), purpura, urticaria, rash,
Clinical Laboratory Test
Creatinine, Blood Urea Nitrogen
Increases ( > 1.25 times the
upper limit of normal) in serum creatinine and blood urea nitrogen were
observed in 3% and 4%, respectively, of patients treated with ACCURETIC. Most
increases were minor and reversible, which can occur in patients with essential hypertension but most frequently in patients with renal artery stenosis (see
PBI and Tests of Parathyroid
Other (Causal Relationships Unknown)
Other clinically important
changes in standard laboratory tests were rarely associated with ACCURETIC
administration. Elevations in uric acid, glucose, magnesium,
cholesterol, triglyceride, and calcium (see PRECAUTIONS) have been