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

Along with its needed effects, ranolazine (the active ingredient contained in Ranexa) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ranolazine:

More common
  • Dizziness
Less common
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • continuous ringing or buzzing or other unexplained noise in the ears
  • difficult or labored breathing
  • fast, irregular, pounding, or racing heartbeat or pulse
  • feeling of constant movement of self or surroundings
  • hearing loss
  • lightheadedness
  • rapid weight gain
  • sensation of spinning
  • tightness in the chest
  • tingling of the hands or feet
  • unusual weight gain or loss
Rare
  • Abnormal or decreased touch sensation
  • agitation
  • blood in the urine
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • chills
  • cold sweats
  • coma
  • confusion
  • decreased urine output
  • depression
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fainting
  • headache
  • hostility
  • irritability
  • lethargy
  • muscle twitching
  • nausea
  • seizures
  • shakiness in the legs, arms, hands, or feet
  • slow or irregular heartbeat
  • stupor
  • sweating
  • trembling or shaking of the hands or feet
  • unusual tiredness or weakness

Some side effects of ranolazine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Difficulty having a bowel movement (stool)
Less common
  • Dry mouth
  • stomach pain
Rare
  • Lack or loss of strength

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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