Ranexa Side Effects

Generic name: ranolazine

Note: This document contains side effect information about ranolazine. Some of the dosage forms listed on this page may not apply to the brand name Ranexa.

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

For the Consumer

Applies to ranolazine: oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking ranolazine (the active ingredient contained in Ranexa) 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 of ranolazine 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.

For Healthcare Professionals

Applies to ranolazine: oral tablet extended release

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 (the active ingredient contained in Ranexa) 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 (the active ingredient contained in Ranexa) 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 (the active ingredient contained in Ranexa) 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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