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Fluvastatin Side Effects

In Summary

More frequently reported side effects include: dyspepsia, myalgia, and accidental injury. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to fluvastatin: oral capsule, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by fluvastatin. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking fluvastatin:

More common:
  • Chills
  • diarrhea
  • fever
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle aches and pain
  • nausea
  • runny nose
  • shivering
  • sore throat
  • sweating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting
Less common:
  • Bladder pain
  • bloody or cloudy urine
  • cough producing mucus
  • dark-colored urine
  • difficult, burning, or painful urination
  • difficulty with breathing
  • difficulty with moving
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • frequent urge to urinate
  • hives
  • itching
  • lower back or side pain
  • muscle cramps, spasms, or stiffness
  • muscular pain, tenderness, wasting, or weakness
  • pain, swelling, or redness in the joints
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash
  • tightness in the chest

Minor Side Effects

Some of the side effects that can occur with fluvastatin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Acid or sour stomach
  • belching
  • headache
  • heartburn
  • indigestion
  • stomach discomfort, upset, or pain
Less common:
  • Bloated or full feeling
  • excess air or gas in the stomach or intestines
  • pain or tenderness around the eyes and cheekbones
  • passing gas
  • unable to sleep

For Healthcare Professionals

Applies to fluvastatin: oral capsule, oral tablet extended release

General

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

Musculoskeletal

Common (1% to 10%): Myalgia, arthritis, arthropathy, arthralgia, pain in extremity, back pain
Rare (0.01% to 0.1%): Muscular weakness, myopathy
Very rare (less than 0.01%): Rhabdomyolysis, myositis, lupus erythematosus-like syndrome
Frequency not reported: Immune-mediated necrotizing myopathy
Postmarketing reports: Muscle cramps, muscle spasms[Ref]

Hepatic

Common (1% to 10%): ALT increased, AST increased
Very rare (less than 0.01%): Hepatitis
Postmarketing reports: Chronic active hepatitis, cholestatic jaundice, fatty change in liver, cirrhosis, fulminant hepatic necrosis, fatal hepatic failure, nonfatal hepatic failure, gamma-glutamyl transpeptidase increased, bilirubin increased[Ref]

Gastrointestinal

Common (1% to 10%): Dyspepsia, diarrhea, abdominal pain, nausea, flatulence, tooth disorder, upper abdominal pain, constipation, gastric disorder
Very rare (less than 0.01%): Pancreatitis
Postmarketing reports: Vomiting[Ref]

Dermatologic

Common (1% to 10%): Rash
Rare (0.01% to 0.1%): Urticaria
Very rare (less than 0.01%): Angioedema, face edema, eczema, dermatitis, bullous exanthema
Postmarketing reports: Bullous dermatitis, alopecia, pruritus, skin nodules, skin discoloration, dry skin/mucous membranes, hair/nails changed[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (16.2%)
Common (1% to 10%): Sinusitis, bronchitis, nasopharyngitis, exertional dyspnea, pharyngitis, rhinitis, cough[Ref]

Other

Common (1% to 10%): Influenza-like symptoms, accidental trauma, fatigue, peripheral edema, blood transaminases increased, creatine phosphokinase increased
Uncommon (0.1% to 1%): Chest pain
Postmarketing reports: Vertigo, alkaline phosphatase increased[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, syncope
Very rare (less than 0.01%): Paresthesia, dysesthesia, hypoesthesia
Postmarketing reports: Tremor, peripheral nerve palsy, peripheral neuropathy, dysfunction of cranial nerve, alteration of taste, extra-ocular movement impaired, facial paresis, cognitive impairment, memory loss, forgetfulness, amnesia, memory impairment[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection
Postmarketing reports: Erectile dysfunction, gynecomastia[Ref]

Cardiovascular

Common (1% to 10%): Atrial fibrillation, hypertension, intermittent claudication
Very rare (less than 0.01%): Vasculitis[Ref]

Hematologic

Very rare (less than 0.01%): Thrombocytopenia[Ref]

Renal

Frequency not reported: Myoglobinuria, acute renal failure[Ref]

Immunologic

Common (1% to 10%): Allergy
Very rare (less than 0.01%): Anaphylactic reaction[Ref]

Hypersensitivity

An apparent hypersensitivity syndrome was reported rarely and included one or more of the following: anaphylaxis, angioedema, lupus erythematosus-like syndrome, polymyalgia rheumatica, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive antinuclear antibodies, erythrocyte sedimentation rate increased, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity reaction, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson syndrome.[Ref]

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

Oncologic

Postmarketing reports: Hepatoma[Ref]

Endocrine

Postmarketing reports: Thyroid function abnormal[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Postmarketing reports: Anxiety, depression, psychic disturbances, loss of libido, confusion[Ref]

Metabolic

Frequency not reported: HbA1c increased, serum glucose increased
Postmarketing reports: Anorexia[Ref]

Ocular

Postmarketing reports: Cataracts progressed, lens opacity, ophthalmoplegia[Ref]

References

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

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

3. "Product Information. Lescol (fluvastatin)." Novartis Pharmaceuticals, East Hanover, NJ.

Not all side effects for fluvastatin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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