Ranexa Side Effects

Generic Name: ranolazine

Please note - some side effects for Ranexa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Ranexa - for the Consumer

Ranexa

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ranexa:

Constipation; dizziness; headache; nausea.

Seek medical attention right away if any of these SEVERE side effects occur when using Ranexa:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blood in the urine; blurred vision; change in the amount of urine produced; chest pain; confusion; decreased sense of touch; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; numbness, burning, prickling, or tingling of the skin; severe or persistent dizziness, light-headedness, or weakness; shortness of breath; swelling of the hands or feet; tremor; unusual bruising or bleeding.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Ranexa Side Effects - for the Professional

Ranexa

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, placebo-controlled, 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 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 2.0% 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

Gastrointestinal Disorders – abdominal pain, dry mouth, vomiting

General Disorders and Administrative Site Adverse Events – peripheral edema

Respiratory, Thoracic, and Mediastinal Disorders – dyspnea

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, blurred vision, confusional state, hematuria, 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 Trials (14.2)].

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.

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Side Effects by Body System - for Healthcare Professionals

Other

Other side effects have included peripheral edema (8.3%), fatigue (7%), asthenia (4.4%), vertigo (4.3%), and influenza (4.2%). Other side effects occurring in less than 2% of patients have included tinnitus.

Nervous system

Nervous system side effects have included dizziness (6.2% to 11.8%) and headache (5.5%). Nervous system reactions that were rare (0.5% or less), but potentially medically important, included hypoesthesia, paraesthesia, and tremor. Additional side effects have included confusional state.

Gastrointestinal

Gastrointestinal side effects have included constipation (4.5% to 10.9%), nausea (4.4% to 5.6%), and diarrhea (3.8%). Other, less common reactions (less than 2%) included abdominal pain, dry mouth, and vomiting.

Cardiovascular

The variable blood levels attained after a given dose of ranolazine result in a wide range of effects on QTc. At Tmax following repeat dosing at 1000 mg twice a day, the mean change in QTc is about 6 msec. However, in 5% of the population with the highest plasma concentrations, the prolongation of QTc is at least 15 msec. The relationship between ranolazine plasma level and QTc is linear over a concentration range up to 4 fold greater than the concentrations produced by a dosage of 1000 mg twice a day, and this relationship is not significantly affected by age, weight, gender, race, heart rate, congestive heart failure NYHA class, or diabetes. In subjects with hepatic impairment, the relationship between plasma level of ranolazine and QTc is much steeper.

During a long-term safety study (ROLE program) involving patients with chronic angina (n=746), there were no treatment discontinuations due to QTc prolongation and no episodes of Torsades de Pointes were reported.

Cardiovascular side effects occurring in less than 2% of patients have included palpitations, bradycardia, hypotension, orthostatic hypotension, and syncope. ECG abnormalities have included dose- and plasma concentration related increases in the QTc interval, reductions in T wave amplitude, and notched T waves.

General

In general, a higher incidence of adverse events has been reported in elderly patients 75 years or older than in younger patients.

In general, long-term therapy with ranolazine is well tolerated in high-risk patients. During a long-term safety study (ROLE program) involving patients with chronic angina (n=746), more than two years after initial dosing, 76.7% of patients remained on therapy and 9.7% discontinued ranolazine due to adverse effects. In this study, age (greater than or equal to 64 years) was associated with increased adverse effects related withdrawals.

Renal

Renal side effects have included small, reversible elevations in serum creatinine and BUN levels. These elevations were observed without evidence of renal toxicity. Renal failure has been rarely (less than 0.5%) reported.

Metabolic

Metabolic side effects have been minimal. Ranolazine does not appear to significantly affect triglyceride or blood glucose levels; however, diabetes has been reported as an adverse effect. In contrast, in patients with diabetes, ranolazine has produced a dose-related reduction in glycosylated hemoglobin (HbA1c).

Respiratory

Respiratory side effects have included cough (6%) and dyspnea (4.3%). Pulmonary fibrosis has been rarely (less than 0.5%) reported.

Musculoskeletal

Musculoskeletal side effects have included back pain (4.8%) and arthralgia (4.4%).

Hematologic

Hematologic side effects have included anemia (4.6%). Additional side effects have included thrombocytopenia, leukopenia, and pancytopenia (less than 0.5%).

Hypersensitivity

Hypersensitivity side effects have included angioedema and eosinophilia (less than 0.5%).

Psychiatric

Psychiatric side effects have included post marketing reports of hallucinations.

Dermatologic

Dermatologic side effects have included angioedema, pruritus and rash.

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