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 |
| 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). |
| Fetal/Neonatal Morbidity and Mortality: | See WARNINGS: Fetal/Neonatal Morbidity and Mortality |
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:
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.
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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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ACCURETIC
Below is a sample of reports where side effects / adverse reactions may be related to Accuretic. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Accuretic side effects / adverse reactions in 60 year old male
Reported by a consumer/non-health professional from Germany on 2007-01-25
Patient: 60 year old male weighing 79.1 kg (174.0 pounds)
Reactions: Myalgia, Burning Sensation, Syncope, Pruritus, Heart Rate Increased, Hypotension, Dizziness, Headache
Suspect drug(s):
Rhinocort Aqua
Dosage: expired
Aleve
Dosage: expired
Administration route: Oral
Indication: Myalgia
Start date: 2007-01-03
Clarinex
Accuretic
Other drugs received by patient: Multi-Vitamin
Possible Accuretic side effects / adverse reactions in 60 year old male
Reported by a individual with unspecified qualification from United States on 2007-03-22
Patient: 60 year old male weighing 78.9 kg (173.6 pounds)
Reactions: Burning Sensation, Pruritus, Syncope, Heart Rate Increased, Hypotension, Dizziness, Headache
Suspect drug(s):
Aleve
Dosage: 220 mg, hs, oral
Administration route: Oral
Indication: Myalgia
Start date: 2007-01-03
Rhinocort
Dosage: nasal
Clarinex
Accuretic
Other drugs received by patient: Multi-Vitamin
Possible Accuretic side effects / adverse reactions in 75 year old male
Reported by a pharmacist from Canada on 2007-05-04
Patient: 75 year old male weighing 81.6 kg (179.6 pounds)
Reactions: Angioedema
Adverse event resulted in: hospitalization
Suspect drug(s):
Efudex
Dosage: 5 pct; bid; tder
Indication: Actinic Keratosis
Accuretic
Dosage: qd; po
Administration route: Oral
Indication: Hypertension
Start date: 2001-01-01
Hydrochlorothiazide
Dosage: 25 mg; qd; po
Administration route: Oral
Indication: Hypertension
Other drugs received by patient: Crestor; Synthroid; Norvasc; Allopurinol; Acetylsalicylic Acid SRT; Atenolol; Nasonex; Pravastatin
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