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Accupril (Quinapril Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Hypertension

ACCUPRIL has been evaluated for safety in 4960 subjects and patients. Of these, 3203 patients, including 655 elderly patients, participated in controlled clinical trials. ACCUPRIL has been evaluated for long-term safety in over 1400 patients treated for 1 year or more.

Adverse experiences were usually mild and transient.

In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 4.7% of patients with hypertension.

Adverse experiences probably or possibly related to therapy or of unknown relationship to therapy occurring in 1% or more of the 1563 patients in placebo-controlled hypertension trials who were treated with ACCUPRIL are shown below.

Adverse Events in Placebo-Controlled Trials
Accupril
(N=1563)
Incidence
(Discontinuance)
Placebo
(N=579)
Incidence
(Discontinuance)
Headache 5.6 (0.7) 10.9 (0.7)
Dizziness 3.9 (0.8) 2.6 (0.2)
Fatigue 2.6 (0.3) 1.0
Coughing 2.0 (0.5) 0.0
Nausea and/or Vomiting 1.4 (0.3) 1.9 (0.2)
Abdominal Pain 1.0 (0.2) 0.7

Heart Failure

ACCUPRIL has been evaluated for safety in 1222 ACCUPRIL treated patients. Of these, 632 patients participated in controlled clinical trials. In placebo-controlled trials, discontinuation of therapy because of adverse events was required in 6.8% of patients with congestive heart failure.

Adverse experiences probably or possibly related or of unknown relationship to therapy occurring in 1% or more of the 585 patients in placebo-controlled congestive heart failure trials who were treated with ACCUPRIL are shown below.

Accupril
(N=585)
Incidence
(Discontinuance)
Placebo
(N=295)
Incidence
(Discontinuance)
Dizziness 7.7 (0.7) 5.1 (1.0)
Coughing 4.3 (0.3) 1.4
Fatigue 2.6 (0.2) 1.4
Nausea and/or Vomiting 2.4 (0.2) 0.7
Chest Pain 2.4 1.0
Hypotension 2.9 (0.5) 1.0
Dyspnea 1.9 (0.2) 2.0
Diarrhea 1.7 1.0
Headache 1.7 1.0 (0.3)
Myalgia 1.5 2.0
Rash 1.4 (0.2) 1.0
Back Pain 1.2 0.3

See PRECAUTIONS, Cough.

Hypertension and/or Heart Failure

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 with CHF or hypertension treated with ACCUPRIL (with or without concomitant diuretic) in controlled or uncontrolled trials (N=4847) and less frequent, clinically significant events seen in clinical trials or post-marketing experience (the rarer events are in italics) include (listed by body system):

General: back pain, malaise, viral infections, anaphylactoid reaction

Cardiovascular: palpitation, vasodilation, tachycardia, heart failure, hyperkalemia, myocardial infarction, cerebrovascular accident, hypertensive crisis, angina pectoris, orthostatic hypotension, cardiac rhythm disturbances, cardiogenic shock

Hematology:   hemolytic anemia

Gastrointestinal: flatulence, dry mouth or throat, constipation, gastrointestinal hemorrhage, pancreatitis, abnormal liver function tests, dyspepsia

Nervous/Psychiatric: somnolence, vertigo, syncope, nervousness, depression, insomnia, paresthesia

Integumentary: alopecia, increased sweating, pemphigus, pruritus, exfoliative dermatitis, photosensitivity reaction, dermatopolymyositis

Urogenital: urinary tract infection, impotence, acute renal failure, worsening renal failure

Respiratory:   eosinophilic pneumonitis

Other: amblyopia, edema, arthralgia, pharyngitis, agranulocytosis, hepatitis, thrombocytopenia

Fetal/Neonatal Morbidity and Mortality

See WARNINGS, Fetal/Neonatal Morbidity and Mortality.

Angioedema

Angioedema has been reported in patients receiving ACCUPRIL (0.1%). Angioedema associated with laryngeal edema may be fatal. If angioedema of the face, extremities, lips, tongue, glottis, and/or larynx occurs, treatment with ACCUPRIL should be discontinued and appropriate therapy instituted immediately. (See WARNINGS.)

Clinical Laboratory Test Findings

Hematology

(See WARNINGS)

Hyperkalemia

(See PRECAUTIONS)

Creatinine and Blood Urea Nitrogen

Increases (>1.25 times the upper limit of normal) in serum creatinine and blood urea nitrogen were observed in 2% and 2%, respectively, of all patients treated with ACCUPRIL alone. Increases are more likely to occur in patients receiving concomitant diuretic therapy than in those on ACCUPRIL alone. These increases often remit on continued therapy. In controlled studies of heart failure, increases in blood urea nitrogen and serum creatinine were observed in 11% and 8%, respectively, of patients treated with ACCUPRIL; most often these patients were receiving diuretics with or without digitalis.



REPORTS OF SUSPECTED ACCUPRIL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Accupril. The information is not vetted and should not be considered as verified clinical evidence.

Possible Accupril side effects / adverse reactions in 52 year old female

Reported by a pharmacist from United States on 2011-10-06

Patient: 52 year old female weighing 93.6 kg (205.9 pounds)

Reactions: Angioedema

Adverse event resulted in: hospitalization

Suspect drug(s):
Accupril

Other drugs received by patient: Lipitor; Nystatin; Trazodone Hydrochloride; Metformin Hydrochloride; Atenolol; Hydrochlorothiazide; Claritin; Cymbalta



Possible Accupril side effects / adverse reactions in 84 year old female

Reported by a consumer/non-health professional from Peru on 2011-10-10

Patient: 84 year old female

Reactions: Cardiac Arrest

Adverse event resulted in: death

Suspect drug(s):
Accupril

Other drugs received by patient: Aspirin; Atenolol; Lasix



Possible Accupril side effects / adverse reactions in 82 year old male

Reported by a consumer/non-health professional from Peru on 2011-10-11

Patient: 82 year old male

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Accupril
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Hypertension

Latanoprost
    Dosage: unk
    Indication: Glaucoma

Lipitor
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Dyslipidaemia



See index of all Accupril side effect reports >>

Drug label data at the top of this Page last updated: 2009-04-24

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