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Table 6 Comparison of adverse reactions reported for the branded and generic drugs

From: A laboratory data-based evaluation of the efficacy and safety of generic pravastatin sodium for long-term use

Adverse reaction

Case (N)

Present study

Package insert

Incidence (%)

Incidence (%)

Increased CPK

9

0.67

Unknown

Myalgia

7

0.52

Unknown

Rash

6

0.45

0.1-1

Discomfort

3

0.22

No documentation

Myospasm

2

0.15

<0.1

Arrhythmia

1

0.07

No documentation

Increased ALP and γ-GTP

1

0.07

0.1–1

Numbness

1

0.07

<0.1

Malaise

1

0.07

<0.1

Nausea

1

0.07

<0.1

Increased AST and ALT

1

0.07

Unknown

Thrombocytopenia

1

0.07

Unknown

Anemia (decreased Hb)

1

0.07

Unknown

Weakness

1

0.07

Unknown

Vertigo

1

0.07

Unknown

  1. Creatine phosphokinase, CPK; gamma-glutamyl transferase, γ-GTP; alkaline phosphatase, ALP; aspartate aminotransferase, AST; alanine aminotransferase, ALT; hemoglobin, Hb