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Ranolazine Side Effects

In Summary

More frequently reported side effects include: constipation, dizziness, and nausea. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ranolazine: oral tablet extended release

Along with its needed effects, ranolazine 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

General

The most common adverse reactions were dizziness, headache, constipation, and nausea.[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, nausea, vomiting
Uncommon (0.1% to 1%): Abdominal pain, dry mouth, dyspepsia, flatulence, stomach discomfort
Rare (less than 0.1%): Pancreatitis, erosive duodenitis, oral hypoesthesia[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache
Uncommon (0.1% to 1%): Lethargy, syncope, hypoesthesia, somnolence, tremor, postural dizziness, paresthesia, vertigo, tinnitus
Rare (less than 0.1%): Amnesia, depressed level of consciousness, loss of consciousness, coordination abnormal, gait disturbance, parosmia[Ref]

Other

Common (1% to 10%): Asthenia
Uncommon (0.1% to 1%): Fatigue, peripheral edema
Rare (less than 0.1%): Impaired hearing[Ref]

Metabolic

Uncommon (0.1% to 1%): Anorexia, appetite decreased, dehydration, weight decreased
Rare (less than 0.1%): Hyponatremia
Postmarketing reports: Hypoglycemia[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety, insomnia, confusional state, hallucination
Rare (less than 0.1%): Disorientation[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Pain in extremity, muscle cramp, joint swelling, muscular weakness[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hot flush, hypotension, prolonged QT corrected interval
Rare (less than 0.1%): Peripheral coldness, orthostatic hypotension
Frequency not reported: Bradycardia, palpitations[Ref]

Genitourinary

Uncommon (0.1% to 1%): Dysuria, hematuria, chromaturia
Rare (less than 0.1%): Urinary retention, erectile dysfunction[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea, cough, epistaxis
Rare (less than 0.1%): Throat tightness
Frequency not reported: Pulmonary fibrosis[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision, visual disturbance, diplopia[Ref]

Renal

Uncommon (0.1% to 1%): Serum creatinine increased, blood urea increased
Rare (less than 0.1%): Acute renal failure
Frequency not reported: Blood urea increased[Ref]

Dermatologic

Uncommon (0.1% to 1%): Pruritus, hyperhidrosis
Rare (less than 0.1%): Angioedema, urticaria, cold sweat, rash[Ref]

Hematologic

Uncommon (0.1% to 1%): Platelet or white blood cell count increased
Frequency not reported: Eosinophilia, thrombocytopenia, leukopenia, pancytopenia[Ref]

Hepatic

Rare (less than 0.1%): Hepatic enzyme levels elevated[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Ranexa (ranolazine)." Calmoseptine Inc, Huntington Beach, CA.

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

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