# Ulipristal

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DRUG INFORMATION

  ADULT
    - • Take one tablet orally as soon as possible, within 120 hours (5 days) after
      unprotected intercourse or a known or suspected contraceptive failure. Take with
      or without food. Take at any time during the menstrual cycle. ( 2.1 ) • After ella
      use, initiate or resume hormonal contraception no sooner than 5 days after the
      intake of ella and use a reliable barrier method until the next menstrual period.
      Source: US FDA label for ulipristal (Ella), section 'dosage and administration',
      retrieved 2026-08-29

  CHILD
    - There is no relevant use of ulipristal acetate for children of prepubertal age in
      the indication emergency contraception . Adolescents: Safety and efficacy of ella
      have been established in women of reproductive age. The clinical trials of ella
      enrolled 41 females under age 18, and a post-marketing observational study
      evaluating effectiveness and safety of ella in adolescents enrolled 279 females
      under age 18, including 76 under age 16 years.
      Source: US FDA label for ulipristal (Ella), section 'pediatric use', retrieved
      2026-08-29

  RENAL IMPAIRMENT
    - However, no difference in efficacy and safety was observed for women of different
      races in clinical studies. 8.7 Hepatic Impairment No studies have been conducted
      to evaluate the effect of hepatic disease on the disposition of ella . 8.8 Renal
      Impairment No studies have been conducted to evaluate the effect of renal disease
      on the disposition of ella .
      Source: US FDA label for ulipristal (Ella), section 'use in specific populations',
      retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - However, no difference in efficacy and safety was observed for women of different
      races in clinical studies. 8.7 Hepatic Impairment No studies have been conducted
      to evaluate the effect of hepatic disease on the disposition of ella . 8.8 Renal
      Impairment No studies have been conducted to evaluate the effect of renal disease
      on the disposition of ella .
      Source: US FDA label for ulipristal (Ella), section 'use in specific populations',
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Ella is contraindicated for use during an existing or suspected
      pregnancy.
      Source: US FDA label for ulipristal (Ella), section 'pregnancy', retrieved
      2026-08-29
    - No signal of concern regarding pregnancy complications was found in postmarketing
      studies [see Data ].
      Source: US FDA label for ulipristal (Ella), section 'pregnancy', retrieved
      2026-08-29
    - Isolated cases of major malformations in ella- exposed pregnancies were
      identified; however, the data are not sufficient to determine a risk for birth
      defects with inadvertent use of ella during pregnancy.
      Source: US FDA label for ulipristal (Ella), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Adverse effects were not observed in the offspring of pregnant rats administered
      ulipristal acetate during the period of organogenesis through lactation at drug
      exposures 1/24 the human exposure based on AUC.
      Source: US FDA label for ulipristal (Ella), section 'use in specific populations',
      retrieved 2026-08-29
    - Administration of ulipristal acetate to pregnant monkeys for 4 days during the
      first trimester caused pregnancy termination in 2/5 animals at daily drug
      exposures 3 times the human exposure based on body surface area. 8.2 Lactation
      Risk Summary Ulipristal acetate and its active metabolite, monodemethyl-ulipristal
      acetate, are present in human milk in small amounts (see Data ).
      Source: US FDA label for ulipristal (Ella), section 'use in specific populations',
      retrieved 2026-08-29
    - Based on the levels of drug and active metabolite measured in breastmilk, a fully
      breastfed child would receive a weight-adjusted dosage of approximately 0.8% of
      ulipristal acetate and monodemethyl-ulipristal acetate on Day 1 of drug
      administration and an approximate total of 1% of the maternal dose over a 5-day
      period after drug administration.
      Source: US FDA label for ulipristal (Ella), section 'use in specific populations',
      retrieved 2026-08-29
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