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Ranexa

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Ranexa

Ranexa

Ranexa Side Effects Center

Medical Editor: Eni Williams, PharmD, PhD

Ranexa (ranolazine) is a medication that belongs to the drug class known as cardiovascular agents. Ranexa is prescribed for the treatment of chronic angina. Common side effects of Ranexa include dizziness, nausea, constipation, headache, swelling in hands, ankles, or feet, slow, fast, or irregular heartbeats, tremors, blood in the urine and shortness of breath.

Ranexa dose range is 500 mg to 1000 mg twice daily. Ranexa drug interactions include, Biaxin (clarithromycin), Kaletra (ritonavir), Diflucan (fluconazole), Sandimmune (cyclosporine), Rifadin (rifampin), Dilantin (phenytoin), Tegretol (carbamazepine) and Zocor (simvastatin). There are no adequate studies of Ranexa in pregnant women and it should only be used during pregnancy if the potential benefit outweighs the potential risk to the fetus. It is not known if Ranexa is excreted in human milk.

Our Ranexa 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ranexa in Detail - Patient Information: Side Effects

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

Call your doctor at once if you have any of these serious side effects:

  • feeling like you might pass out;
  • swelling in your hands, ankles, or feet;
  • slow, fast, or pounding heartbeats;
  • tremors or shaking;
  • blood in your urine;
  • urinating less than usual or not at all;
  • shortness of breath; or
  • skin rash, bruising, severe tingling, numbness, pain, and muscle weakness.

Less serious side effects may include:

  • mild dizziness, spinning sensation, headache;
  • dry mouth;
  • mild nausea, vomiting, stomach pain, constipation;
  • weakness; or
  • ringing in your ears.

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 Ranexa (Ranolazine) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ranexa FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 2,018 patients with chronic angina were treated with ranolazine in controlled clinical trials. Of the patients treated with RANEXA, 1,026 were enrolled in three double-blind, placebocontrolled, randomized studies (CARISA, ERICA, MARISA) of up to 12 weeks' duration. In addition, upon study completion, 1,251 patients received treatment with RANEXA in open-label, long-term studies; 1,227 patients were exposed to RANEXA for more than 1 year, 613 patients for more than 2 years, 531 patients for more than 3 years, and 326 patients for more than 4 years.

At recommended doses, about 6% of patients discontinued treatment with RANEXA because of an adverse event in controlled studies in angina patients compared to about 3% on placebo. The most common adverse events that led to discontinuation more frequently on RANEXA than placebo were dizziness (1.3% versus 0.1%), nausea (1% versus 0%), asthenia, constipation, and headache (each about 0.5% versus 0%). Doses above 1000 mg twice daily are poorly tolerated.

In controlled clinical trials of angina patients, the most frequently reported treatment-emergent adverse reactions ( > 4% and more common on RANEXA than on placebo) were dizziness (6.2%), headache (5.5%), constipation (4.5%), and nausea (4.4%). Dizziness may be doserelated. In open-label, long-term treatment studies, a similar adverse reaction profile was observed.

The following additional adverse reactions occurred at an incidence of 0.5 to 4.0% in patients treated with RANEXA and were more frequent than the incidence observed in placebo-treated patients:

Cardiac Disorders - bradycardia, palpitations

Ear and Labyrinth Disorders - tinnitus, vertigo

Eye Disorders - blurred vision

Gastrointestinal Disorders - abdominal pain, dry mouth, vomiting, dyspepsia

General Disorders and Administrative Site Adverse Events - asthenia, peripheral edema

Metabolism and Nutrition Disorders - anorexia

Nervous System Disorders - syncope (vasovagal)

Psychiatric Disorders - confusional state

Renal and Urinary Disorders - hematuria

Respiratory, Thoracic, and Mediastinal Disorders - dyspnea

Skin and Subcutaneous Tissue Disorders - hyperhidrosis

Vascular Disorders - hypotension, orthostatic hypotension

Other ( < 0.5%) but potentially medically important adverse reactions observed more frequently with RANEXA than placebo treatment in all controlled studies included: angioedema, renal failure, eosinophilia, chromaturia, blood urea increased, hypoesthesia, paresthesia, tremor, pulmonary fibrosis, thrombocytopenia, leukopenia, and pancytopenia.

A large clinical trial in acute coronary syndrome patients was unsuccessful in demonstrating a benefit for RANEXA, but there was no apparent proarrhythmic effect in these high-risk patients [see Clinical Studies].

Laboratory Abnormalities

RANEXA produces small reductions in hemoglobin A1c. RANEXA is not a treatment for diabetes.

RANEXA produces elevations of serum creatinine by 0.1 mg/dL, regardless of previous renal function. The elevation has a rapid onset, shows no signs of progression during long-term therapy, is reversible after discontinuation of RANEXA, and is not accompanied by changes in BUN. In healthy volunteers, RANEXA 1000 mg twice daily had no effect upon the glomerular filtration rate. The elevated creatinine levels are likely due to a blockage of creatinine's tubular secretion by ranolazine or one of its metabolites.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of RANEXA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

Nervous System Disorders

Tremor, paresthesia, abnormal coordination, and other serious neurologic adverse events have been reported to occur, sometimes concurrently, in patients taking ranolazine. The onset of events was often associated with an increase in ranolazine dose or exposure. Many patients reported symptom resolution following drug discontinuation or dose decrease.

Psychiatric Disorders - hallucination

Renal and Urinary Disorders - dysuria, urinary retention

Skin and Subcutaneous Tissue Disorders - angioedema, pruritus, rash

Read the entire FDA prescribing information for Ranexa (Ranolazine) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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