Fluvastatin Sodium (Page 3 of 11)
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the label:
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- Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [see Warnings and Precautions (5.1)].
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- Liver Enzyme Abnormalities [see Warnings and Precautions (5.2)].
6.1 Clinical Studies Experience in Adult Patients
Because clinical studies on fluvastatin are conducted in varying study populations and study designs, the frequency of adverse reactions observed in the clinical studies of fluvastatin cannot be directly compared with that in the clinical studies of other statins and may not reflect the frequency of adverse reactions observed in clinical practice.
In the fluvastatin capsules placebo-controlled clinical trials database of 2326 patients treated with fluvastatin capsules (age range 18-75 years, 44% women, 94% Caucasians, 4% Blacks, 2% other ethnicities) with a median treatment duration of 24 weeks, 3.4% of patients on fluvastatin and 2.3% patients on placebo discontinued due to adverse reactions regardless of causality. The most common adverse reactions that led to treatment discontinuation and occurred at an incidence greater than placebo were: transaminase increased (0.8%), upper abdominal pain (0.3%), dyspepsia (0.3%), fatigue (0.2%) and diarrhea (0.2%).
Clinically relevant adverse experiences occurring in the fluvastatin capsules controlled studies with a frequency ≥ 2%, regardless of causality, included the following:
| |||
Fluvastatin Capsules * N = 2326 (%) | Placebo * N = 960 (%) | ||
Musculoskeletal | Myalgia | 5.0 | 4.5 |
Arthritis | 2.1 | 2.0 | |
Arthropathy | NA | NA | |
Respiratory | Sinusitis | 2.6 | 1.9 |
Bronchitis | 1.8 | 1.0 | |
Gastrointestinal | Dyspepsia | 7.9 | 3.2 |
Diarrhea | 4.9 | 4.2 | |
Abdominal pain | 4.9 | 3.8 | |
Nausea | 3.2 | 2.0 | |
Flatulence | 2.6 | 2.5 | |
Tooth disorder | 2.1 | 1.7 | |
Psychiatric | Insomnia | 2.7 | 1.4 |
Genitourinary | Urinary tract infection | 1.6 | 1.1 |
Headache | 8.9 | 7.8 | |
Influenza-like symptoms | 5.1 | 5.7 | |
Accidental Trauma | 5.1 | 4.8 | |
Fatigue | 2.7 | 2.3 | |
Allergy | 2.3 | 2.2 |
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