Summary

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

Applies to ranolazine: oral packet, oral tablet extended release.

Serious side effects of Ranolazine

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
• chest tightness
• difficult or labored breathing
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling of constant movement of self or surroundings
• lightheadedness
• rapid weight gain
• sensation of spinning
• 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

Incidence not known

• Decrease in frequency of urination
• decrease in urine volume
• difficulty in passing urine [dribbling]
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• painful urination
• seeing, hearing, or feeling things that are not there

Other side effects of Ranolazine

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

• Acid or sour stomach
• belching
• continuing ringing or buzzing or other unexplained noise in the ears
• hearing loss
• heartburn
• indigestion
• lack or loss of strength
• stomach discomfort or upset
• vomiting

For Healthcare Professionals

Applies to ranolazine: oral granule extended release, 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

Postmarketing reports: Myoclonus^[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]