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Rosuvastatin Side Effects

For the Consumer

Applies to rosuvastatin: oral tablet

Along with its needed effects, rosuvastatin 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 rosuvastatin:

Rare
  • Dark-colored urine
  • fever
  • muscle cramps or spasms
  • muscle pain, stiffness, tenderness, wasting, or weakness
  • unusual tiredness or weakness
Incidence not known
  • Abdominal or stomach pain
  • clay-colored stools
  • skin rash
  • unpleasant breath odor
  • vomiting of blood
  • yellow eyes or skin

Some side effects of rosuvastatin 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
  • Body aches or pain
  • congestion
  • cough
  • difficulty with moving
  • dry or sore throat
  • headache
  • hoarseness
  • pain in the joints
  • runny nose
  • tender, swollen glands in the neck
  • trouble swallowing
  • voice changes
Less common
  • Accidental injury
  • accumulation of pus, swollen, red, or tender area of infection near a tooth
  • acid or sour stomach
  • arm, back, or jaw pain
  • belching
  • bladder pain
  • bloated or full feeling
  • bloody or cloudy urine
  • blurred vision
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • chest tightness or heaviness
  • chills
  • constipation
  • depression
  • diarrhea
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • discouragement
  • dizziness
  • dry mouth
  • excess air or gas in the stomach or intestines
  • excessive muscle tone
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fear
  • feeling faint
  • feeling of constant movement of self or surroundings
  • feeling of warmth or heat
  • feeling sad or empty
  • flushed, dry skin
  • flushing or redness of the skin especially on the face and neck
  • fruit-like breath odor
  • general feeling of discomfort or illness
  • heartburn
  • increased hunger
  • increased thirst
  • increased urination
  • irritability
  • itching skin
  • lack of appetite
  • lack or loss of strength
  • lightheadedness
  • loss of appetite
  • loss of consciousness
  • loss of interest or pleasure
  • muscle tension or tightness
  • nausea
  • neck pain
  • nerve pain
  • nervousness
  • pain or swelling in the arms or legs without any injury
  • pain or tenderness around the eyes and cheekbones
  • pain, swelling, or redness in the joints
  • pale skin
  • passing gas
  • pounding in the ears
  • sensation of spinning
  • shivering
  • slow heartbeat
  • sneezing
  • stomach pain, discomfort, tenderness, or upset
  • stuffy nose
  • sweating
  • swelling of the hands, ankles, feet, or lower legs
  • trouble concentrating
  • trouble sleeping
  • unexplained weight loss
  • unusual bleeding or bruising
  • vomiting

For Healthcare Professionals

Applies to rosuvastatin: oral tablet

General

The most frequently reported side effects included headache, myalgia, abdominal pain, asthenia, and nausea.[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 12.7%), arthralgia (10.1%)
Rare (less than 0.1%): Myopathy, rhabdomyolysis, myositis
Frequency not reported: Immune-mediated necrotizing myopathy, tendon disorders, creatine phosphokinase increased[Ref]

Gastrointestinal

Common (1% to 10%): Abdominal pain, nausea, constipation
Rare (less than 0.1%): Pancreatitis
Frequency not reported: Diarrhea[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness
Very rare (less than 0.01%): Polyneuropathy, memory loss
Postmarketing reports: Cognitive impairment, forgetfulness, amnesia, memory impairment, peripheral neuropathy[Ref]

Hepatic

Rare (0.01% to 0.1%): Hepatic transaminases/enzymes increased
Very rare (less than 0.01%): Jaundice, hepatitis
Frequency not reported: Bilirubin increased
Postmarketing reports: Fatal hepatic failure, nonfatal hepatic failure[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, pruritus, urticaria
Rare (less than 0.1%): Angioedema
Frequency not reported: Stevens-Johnson syndrome[Ref]

Renal

Frequency not reported: Acute renal failure[Ref]

Genitourinary

Very rare (less than 0.01%): Hematuria
Frequency not reported: Proteinuria, myoglobinuria, sexual dysfunction[Ref]

Other

Common (1% to 10%): Asthenia
Frequency not reported: Edema, glutamyl transpeptidase increased, alkaline phosphatase increased[Ref]

Respiratory

Frequency not reported: Cough, dyspnea, interstitial lung disease[Ref]

Psychiatric

Frequency not reported: Confusion, depression, insomnia, nightmares, sleep disorders/disturbances[Ref]

Endocrine

Very rare (less than 0.01%): Gynecomastia
Frequency not reported: Thyroid function abnormalities[Ref]

Metabolic

Common (1% to 10%): Diabetes mellitus
Frequency not reported: Glucose elevated, HbA1c increased[Ref]

Hematologic

Rare (less than 0.1%): Thrombocytopenia[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity reaction[Ref]

References

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

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Crestor (rosuvastatin)." AstraZeneca Pharma Inc, Mississauga, ON.

Some side effects of rosuvastatin 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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