Lipitor (Atorvastatin) Adverse Reactions
- abdominal pain
- alopecia
- anaphylactoid reactions
- angioedema
- arthralgia
- asthenia
- back pain
- bullous rash
- chills
- cholestasis
- cirrhosis
- constipation
- diarrhea
- drowsiness
- dyspepsia
- dyspnea
- edema
- elevated hepatic enzymes
- eosinophilia
- erythema
- erythema multiforme
- fatigue
- fever
- flatulence
- flushing
- headache
- hemolytic anemia
- hepatic failure
- hepatic necrosis
- hepatitis
- infection
- jaundice
- leukopenia
- lupus-like symptoms
- malaise
- myalgia
- myasthenia
- myoglobinuria
- myopathy
- nausea/vomiting
- pancreatitis
- peripheral edema
- pharyngitis
- photosensitivity
- pruritus
- purpura
- rash (unspecified)
- renal tubular obstruction
- rhabdomyolysis
- sinusitis
- Stevens-Johnson syndrome
- thrombocytopenia
- toxic epidermal necrolysis
- urticaria
- vasculitis
- weakness
Lipitor (Atorvastatin) Adverse Reactions
Atorvastatin is generally well-tolerated. Less than 2% of patients discontinue therapy due to adverse events. As reported by the manufacturer, the most frequent adverse reactions thought to be related to atorvastatin therapy were constipation, flatulence, dyspepsia, and abdominal pain. Adverse reactions occurring in >= 2% of patients in placebo-controlled studies, regardless of causality assessment, include infection, headache, accidental injury, flu-like syndrome, back pain, allergic reaction, asthenia, diarrhea, sinusitis, pharyngitis, rash, and arthralgia. Nausea/vomiting has been reported in >= 2% of patients receiving atorvastatin. Pediatric patients aged 10-17 years treated with atorvastatin have been reported to have an adverse experience profile generally similar to placebo. In a limited controlled study by the manufacturer, there has been no detectable effect on growth or sexual maturation in boys or on menstrual cycle length in postmenarchal girls.
HMG-CoA reductase inhibitors have been associated with toxicity to skeletal muscles. Myopathy, defined as muscle aches or muscle weakness in conjunction with increases in creatine phosphokinase (CPK) values > 10 times upper limit of normal (ULN), should be considered in any patient with diffuse myalgias, unexplained muscle tenderness or weakness, and/or marked elevation of CPK. Any evidence of myalgia, muscle weakness (myasthenia), or elevated CPK values may indicate myopathy, particularly if symptoms include fever, lethargy/drowsiness, fatigue, and/or malaise. Clinicians should note that rhabdomyolysis and renal failure (renal tubular obstruction, myoglobinuria) have been associated with HMG-CoA reductase inhibitor therapy including atorvastatin. Statin-induced myopathy is generally dose-related. The risk of developing myopathy is increased when HMG-CoA reductase inhibitors are used in combination with interacting drugs (see Drug Interactions). Atorvastatin should be discontinued immediately in any patient who develops myopathy or elevations in CPK.
Although rare, severe hepatoxicity may occur during HMG-CoA reductase inhibitor therapy. Hepatitis, fatty changes of the liver, cholestasis with jaundice, cirrhosis, fulminant hepatic necrosis, hepatic failure, and pancreatitis have been reported during therapy with HMG-CoA reductase inhibitors. HMG-CoA reductase inhibitor therapy may be associated with elevated hepatic enzymes. This condition generally resolves upon withdrawal of the drug. Only 0.7% of patients developed persistent increased transaminase levels while receiving atorvastatin. The incidence of these elevations was 0.2%, 0.6%, 0.6%, and 2.3% for 10, 20, 40, and 80 mg, respectively. Liver function tests should be performed before the initiation of treatment, and at 12 weeks after initiation of therapy or elevation in dose, and periodically (e.g., every 6 months) thereafter.
Other adverse events exceeding 2% (without regard to causality) reported during clinical trials with atorvastatin have included: chest pain (unspecified), bronchitis, rhinitis, insomnia, dizziness, arthritis, urinary tract infection, hematuria, and albuminuria.
Rash (unspecified) has occurred during atorvastatin therapy (1.1-3.9% during placebo-controlled clinical trials). Dermatological and hypersensitivity events reported rarely during post-marketing experience with atorvastatin, regardless of causality, include: anaphylaxis, angioedema, bullous rash, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Face edema and generalized edema has been reported in < 1% of patients receiving atorvastatin during clinical trials. Peripheral edema has been reported in >= 2% of patients (without regard to causality). Less frequent reactions (< 1%, without regard to causality) during atorvastatin therapy may include acne, alopecia, contact dermatitis, diaphoresis, dry skin, eczema, pruritus, seborrhea, urticaria, or skin ulcer. A variety of general skin changes (e.g., nodules, discoloration, dryness of mucous membranes, changes to hair/nails) have been reported during HMG-CoA reductase inhibitor therapy. An apparent hypersensitivity syndrome has been reported rarely with HMG-CoA reductase inhibitors which has included one or more of the following features or anaphylactoid reactions: anaphylaxis, angioedema, lupus-like symptoms, polymyalgia rheumatica, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive ANA, ESR increase, eosinophilia, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, chills, flushing, malaise, dyspnea, toxic epidermal necrolysis, erythema multiforme, and Stevens-Johnson syndrome.
[ Last revised: 1/24/2006 4:16:00 PM ]
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