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ACCURETIC® (quinapril HCl, hydrochlorothiazide) Adverse Reactions

ADVERSE REACTIONS

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
  Quinapril/HCTZ
N = 943
Placebo
N = 100
Headache6.730.0
Dizziness4.84.0
Coughing3.22.0
Fatigue2.93.0
Myalgia2.45.0
Viral Infection1.94.0
Rhinitis2.03.0
Nausea and/or Vomiting1.86.0
Abdominal Pain1.74.0
Back Pain1.52.0
Diarrhea1.41.0
Upper Respiratory Infection1.34.0
Insomnia1.22.0
Somnolence1.20.0
Bronchitis1.21.0
Dyspepsia1.22.0
Asthenia1.11.0
Pharyngitis1.12.0
Vasodilatation1.01.0
Vertigo1.02.0
Chest Pain1.02.0

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).

Postmarketing Experience

The following serious nonfatal adverse events, regardless of their relationship to quinapril and HCTZ combination tablets, have been reported during extensive postmarketing experience:

Non-melanoma Skin Cancer: Hydrochlorothiazide is associated with an increased risk of non-melanoma skin cancer. In a study conducted in the Sentinel System, increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000 mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.

BODY AS A WHOLE: Shock, accidental injury, neoplasm, cellulitis, ascites, generalized edema, hernia and anaphylactoid reaction.

CARDIOVASCULAR SYSTEM: Bradycardia, cor pulmonale, vasculitis, and deep thrombosis.

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 arthritis.

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, and petechiases.

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 anorexia.
NEUROLOGIC:Vertigo, lightheadedness, transient blurred vision, headache, paresthesia, xanthopsia, weakness, and restlessness.
MUSCULOSKELETAL:Muscle spasm.
HEMATOLOGIC:Aplastic anemia, agranulocytosis, leukopenia, thrombocytopenia, and hemolytic anemia.
RENAL:Renal 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, and photosensitivity.

Clinical Laboratory Test Findings

Serum Electrolytes

See PRECAUTIONS.

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 PRECAUTIONS).

PBI and Tests of Parathyroid Function

See PRECAUTIONS.

Hematology

See WARNINGS.

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 reported.

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