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Accupril

Last reviewed on RxList: 2/24/2017
Accupril Side Effects Center

Last reviewed on RxList 11/30/2016

Accupril (quinapril) is an angiotensin converting enzyme (ACE) inhibitor used for treating high blood pressure and heart failure. Generic formulations of Accupril are available. Common side effects of Accupril include:

The recommended dose for treating hypertension is 10-80 mg a day as a single dose or in two doses. The dose for heart failure is 20-40 mg a day in two divided doses. Accupril interacts with potassium supplements, salt substitutes, potassium sparring diuretics (e.g., spironolactone), lithium, and nonsteroidal anti-inflammatory drugs. Do not use Accupril if you are pregnant. Stop using Accupril and tell your doctor right away if you become pregnant. Accupril can cause injury or death to the unborn baby if you take it during your second or third trimester. Talk to your doctor about using effective birth control while taking Accupril. Accupril can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Our Accupril (quinapril) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Accupril Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • feeling like you might pass out;
  • fever, chills, body aches, flu symptoms;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling);
  • chest pain;
  • urinating more or less than usual, or not at all;
  • swelling, rapid weight gain; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache;
  • cough;
  • muscle pain, back pain;
  • dizziness, tired feeling;
  • nausea, vomiting, diarrhea, stomach discomfort; or
  • mild skin itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Accupril (Quinapril Hydrochloride)

Accupril Professional Information

SIDE EFFECTS

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=585)
Incidence
(Discontinuance)
Placebo
(N=295)
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

Metabolism and Nutrition Disorders: hyponatremia

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

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.

Read the entire FDA prescribing information for Accupril (Quinapril Hydrochloride)

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