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:

Rhabdomyolysis with myoglobinuria and acute renal failure and myopathy (including myositis) [see Warnings and Precautions (5.1)].
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:

Table 1: Clinical Adverse Events Reported in ≥ 2% in Patients Treated with Fluvastatin and at an Incidence Greater than Placebo in Placebo-Controlled Trials Regardless of Causality (% of Patients) Pooled Dosages
*
Controlled trials with fluvastatin capsules (20 and 40 mg daily and 40 mg twice daily) compared to placebo

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

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.