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Ulipristal Off Label Review

Ulipristal is an emergency contraceptive tablet which is used to prevents unwanted pregnancy within 120 hours after unprotected sex.


Indications for use

  • Emergency contraception.

Mechanism of action

Ulipristal is a synthetic selective modulator of progesterone receptors. It inhibits ovulation and allows to delay the rupture of the follicle in women when taken just before the expected ovulation.

The drug has a high affinity for progesterone, glucocorticosteroid receptors, low affinity for androgen receptors, and has no affinity for estrogen or mineralocorticoid receptors.

Dosage and mode of application

Ulipristal 30 mg (1 tablet) should be taken as soon as possible but no later than 120 hours (5 days) after unprotected sexual intercourse or if the contraceptive method used was unreliable.

The tablet can be taken regardless of foods and time of a day.

If vomiting occurs within 3 hours after taking a tablet, take an additional one. The drug can be taken any day of the menstrual cycle. Before taking the drug, pregnancy should be excluded.

Side effects

In some cases, Ulipristal tablet can cause the following side effects:

  • headache, dizziness;
  • mood disorders;
  • nausea, vomiting, abdominal pain (unspecified), pain in the upper abdomen, discomfort in the abdomen;
  • myalgia, back pain;
  • dysmenorrhea, sensitivity in the mammary glands, pain in the pelvis;
  • increased fatigue;
  • anxiety, sleep disorders, hyperactivity, emotional disorders, migraine;
  • pain, irritability, chills, general malaise, hyperthermia;
  • poor appetite, dry mouth, flatulence, diarrhea, constipation, pain in the lower abdomen;
  • colds, rhinopharyngitis;
  • visual impairment;
  • acne, skin changes, itching;
  • vaginitis, menorrhagia, vaginal discharge, menstrual irregularities, uterine bleeding, vaginal bleeding, premenstrual syndrome, “hot flashes”;
  • urinary tract infection;
  • infectious conjunctivitis;
  • dehydration, thirst;
  • discomfort in the chest area;
  • disorientation;
  • tremor, violation of attention, dysgeusia, violation of sleep quality, parosmia (perversion of smell), fainting;
  • unpleasant sensations in the eye area, hyperemia of the mucous eyes, photophobia
  • bleeding;
  • edema of the upper respiratory tract, cough, dryness in the pharynx, epistaxis (nosebleed);
  • pain in the extremities;
  • gastroesophageal reflux disease, toothache;
  • urticaria;
  • inflammatory pelvic organs diseases;
  • urinary tract diseases, chromaturia, nephrolithiasis, pain in the kidney,
  • itching in the area of the external genitalia, dysfunctional uterine bleeding, dyspareunia, rupture of the ovarian cyst, vulvovaginal pain;
  • discomfort during menstruation, hypomenorrhoea;
  • increased libido.


Ulipristal contraindications include:

  • hypersensitivity;
  • bleeding from the vagina of unknown origin or for reasons unrelated to uterine myoma;
  • breast cancer;
  • cervical cancer;
  • uterine cancer;
  • ovarian cancer;
  • severe renal failure (in the absence of continuous monitoring of the patient);
  • moderate or severe hepatic insufficiency (in the absence the possibility of constant monitoring of the patient);
  • severe bronchial asthma, which can not be corrected by oral glucocorticosteroids;
  • lactation period;
  • pregnancy;
  • age under 18 years.


  • Rifampicin, phenytoin, phenobarbital, carbamazepine, St. John’s wort / Hypericum perforatum can reduce the concentration of ulipristal acetate in the plasma and thus contribute to a decrease in the effectiveness of the drug;
  • Ritonavir can reduce the concentration of ulipristal acetate in the plasma;
  • Ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin, nefazodone can enhance the effect of ulipristal acetate;
  • Proton pump inhibitors, antacids and H2 receptor antagonists reduce the concentration of ulipristal acetate in the blood plasma;
  • The combined use of ulipristal acetate and P-glycoprotein substrates (dabigatran etexilate, digoxin) is not recommended due to the lack of clinical data;
  • Ulipristal can reduce the contraceptive effect of combined hormonal contraceptives and progestogen-only contraceptives;
  • The combined use of ulipristal acetate and other emergency contraceptive products containing levonorgestrel is not recommended.

Pregnancy and breastfeeding

The use of the emergency contraception is contraindicated in pregnancy.

It is not known whether ulipristal is excreted in breast milk. It can be theoretically excreted in breast milk, so it is impossible to exclude the risk for the child. After taking the drug, it is recommended to stop breastfeeding for at least 36 hours.


The drug is intended for emergency contraception and cannot be used as a regular contraceptive. In any case, a woman should be advised to use the methods of regular contraception.

Although the use of Ulipristal is not a contraindication to the continued use of drugs for regular contraception, it may reduce their contraceptive effect. Therefore, after taking a morning-after tablet, it is recommended to use barrier contraceptive methods every subsequent intercourse until you have your next menstruation.

It is not recommended to use emergency contraception repeatedly during one menstrual cycle.

The drug does not prevent pregnancy in all cases.

If pregnancy has occurred after taking the tablet, it is necessary to take into account the possibility of having an ectopic pregnancy.

Sometimes, the tablet can affect the duration of the menstrual period.

There are no special recommendations regarding the dose of ulipristal in women with renal and hepatic insufficiency.

There are no data regarding the influence of emergency contraception on the ability to manage vehicles and mechanisms. Theoretically, the drug may affect the ability to drive vehicles and mechanisms since in some cases it causes dizziness, drowsiness, impaired vision, or attention impairment.

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