Safety considerations

Safety Profile

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

Important Safety Information

  • Paragard must not be used by women who have acute pelvic inflammatory disease (PID); have had a postpregnancy or postabortion uterine infection in the past 3 months; have cancer of the uterus or cervix; have an infection of the cervix; have an allergy to any component; or have Wilson’s disease. Continue reading

Paragard is indicated for intrauterine contraception for up to 10 years.

Important Safety Information

  • Paragard must not be used by women who have acute pelvic inflammatory disease (PID); have had a postpregnancy or postabortion uterine infection in the past 3 months; have cancer of the uterus or cervix; have an infection of the cervix; have an allergy to any component; or have Wilson’s disease.
  • If a woman misses her period, she must be promptly evaluated for pregnancy.
  • Possible serious complications that have been associated with intrauterine contraceptives are PID, embedment, perforation of the uterus, and expulsion.
  • Paragard must not be used by women who are pregnant as this can be life threatening and may result in loss of pregnancy or infertility.
  • The most common side effects of Paragard are bleeding and spotting; for most women, these typically subside after 2 to 3 months.
  • Paragard does not protect against HIV or other sexually transmitted infections (STI).

For full product information, please see the Full Prescribing Information.