Safety Profile

Contraindications1

PARAGARD should not be placed when one or more of the following conditions exist:

  • Pregnancy or suspicion of pregnancy
  • Abnormalities of the uterus resulting in distortion of the uterine cavity
  • Acute pelvic inflammatory disease, or current behavior suggesting a high risk for pelvic inflammatory disease
  • Postpartum endometritis or postabortal endometritis in the past 3 months
  • Known or suspected uterine or cervical malignancy
  • Genital bleeding of unknown etiology
  • Mucopurulent cervicitis
  • Wilson's disease
  • Allergy to any component of PARAGARD
  • A previously placed IUD that has not been removed

WARNINGS

  • Intrauterine pregnancy
  • Ectopic pregnancy
  • Pelvic infection
  • lmmunocompromise
  • Embedment
  • Perforation
  • Expulsion
  • Wilson's disease

Adverse Reactions

Summary of rates (no. per 100 subjects) by year for adverse events causing discontinuation

Rates were calculated by weighting the annual rates by the number of subjects starting each year for each of the Population Council (3536 subjects) and the World Health Organization (1396 subjects) trials.

The most serious adverse events associated with PARAGARD include:

  • Intrauterine pregnancy
  • Septic abortion
  • Ectopic pregnancy
  • Pelvic infection
  • Perforation
  • Embedment

The following adverse events have also been observed:

  • Anemia
  • Backache
  • Dysmenorrhea
  • Dyspareunia
  • Expulsion, complete or partial
  • Leukorrhea
  • Menstrual flow, prolonged
  • Menstrual spotting
  • Pain and cramping
  • Urticarial allergic skin reaction
  • Vaginitis

Reference: 1. PARAGARD® T 380A [Prescribing Information]. Trumbull, CT. CooperSurgical, Inc.