Ranexa

• Generic Name: ranolazine
• Brand Name: Ranexa
• Drug Class: How Do Non-nitrates Antianginals Work?

Ranexa (Ranolazine) side effects drug center

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PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Professional Information

 

Ranexa Side Effects Center

What Is Ranexa?

Ranexa (ranolazine) is an anti-anginal medication prescribed to treat chronic angina.

What Are Side Effects of Ranexa?

Common side effects of Ranexa include:

• dizziness,
• spinning sensation,
• nausea,
• vomiting,
• stomach pain,
• constipation,
• headache,
• dry mouth,
• weakness,
• ringing in your ears,
• swelling in hands/ankles/feet,
• slow/fast/irregular heartbeats,
• tremors,
• blood in the urine, and
• shortness of breath.

Dosage for Ranexa

Ranexa dose range is 500 mg to 1000 mg twice daily.

What Drugs, Substances, or Supplements Interact with Ranexa?

Ranexa drug interactions include, Biaxin (clarithromycin), Kaletra (ritonavir), Diflucan (fluconazole), Sandimmune (cyclosporine), Rifadin (rifampin), Dilantin (phenytoin), Tegretol (carbamazepine) and Zocor (simvastatin).

Ranexa During Pregnancy and Breastfeeding

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 unknown if Ranexa passes into breast milk or if it could harm a nursing baby. Breastfeeding while using Ranexa is not recommended.

Additional Information

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

 

Ranexa Consumer Information

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

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• fast or pounding heartbeats, fluttering in your chest; or
• kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.

Common side effects may include:

• nausea, constipation;
• headache; or
• dizziness.

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)

 

Ranexa Professional Information

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 2018 patients with chronic angina were treated with ranolazine in controlled clinical trials. Of the patients treated with RANEXA, 1026 were enrolled in three double-blind, placebo-controlled, randomized studies (CARISA, ERICA, MARISA) of up to 12 weeks’ duration. In addition, upon study completion, 1251 patients received treatment with RANEXA in open-label, long-term studies; 1227 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 dose-related. 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 elevations of serum creatinine by 0.1 mg/dL, regardless of previous renal function, likely because of inhibition of creatinine’s tubular secretion. In general, 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. More marked and progressive increases in serum creatinine, associated with increases in BUN or potassium, indicating acute renal failure, have been reported after initiation of RANEXA in patients with severe renal impairment [see WARNINGS AND PRECAUTIONS, Use In Specific Populations].

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 – Abnormal coordination, myoclonus, paresthesia, tremor, 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.

Metabolism and Nutrition Disorders – Cases of hypoglycemia have been reported in diabetic patients on antidiabetic medication.

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)