Ranolazine Side Effects

Brand Names: Ranexa

Please note - some side effects for Ranolazine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ranolazine - for the Consumer

Ranolazine

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 Ranolazine:

Constipation; dizziness; headache; nausea.

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; fever, chills, or persistent sore throat; irregular or slow heartbeat; numbness, burning, prickling, or tingling of the skin; ringing in the ears; severe or persistent dizziness or weakness; shortness of breath; swelling of the hands or feet; tremor; unusual bruising or bleeding.

Side Effects by Body System

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%).

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.