Most common adverse reactions in controlled Fibromyalgia trials
(Reactions in ≥5% of all LYRICA-treated patients and occurring at twice the rate of placebo)

Adverse reactions were generally mild to moderateinformationinformationinformationinformation

 

Additional information

Dizziness1

  • May occur within 1-3 days
  • 6% discontinuation rate for LYRICA vs <1% for placebo
  • Data are from a pooled analysis of safety information from FM trials

Somnolence1

  • May occur within 2-4 days
  • 3% discontinuation rate for LYRICA vs <1% for placebo
  • Data are from a pooled analysis of safety information from FM trials

Weight gain

In LYRICA controlled trials of up to 14 weeks:

  • ~1% of LYRICA patients discontinued due to weight gain vs <1% for placebo
  • Weight gain was not associated with clinically important changes in blood pressure in these studies; the long-term cardiovascular effects of LYRICA-associated weight gain are unknown
     

Weight Again

Peripheral edema

  • ≤1% of LYRICA patients discontinued due to peripheral edema vs <1% for placebo
  • Peripheral edema had no apparent association with:
    • Cardiovascular complications (eg, hypertension or congestive heart failure)
    • Laboratory changes in renal or hepatic function

These data are from short-term trials of patients without clinically significant heart or peripheral
vascular disease (as defined by the New York Heart Association Class III or IV cardiac status). LYRICA
should be used with caution in these patients.

Reference:

1. Data on file. Integrated summary of clinical safety (pivotal Fibromyalgia studies). Pfizer Inc, New York, NY.