Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Fibristal (Ulipristal). If you are concerned about side effects, discuss the risks and benefits of Fibristal (Ulipristal) with your doctor.

The following side effects have been reported by at least 1% of people taking Fibristal (Ulipristal). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Acne
• Constipation
• fatigue
• hair loss
• headache
• hot flushes
• endometrial thickening
• nausea
• Obesity
• sensation of spinning
• vaginal discharge

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abnormal or heavy uterine bleeding that is worsening
• breast pain or discomfort
• new uterine fibroids
• ovarian cysts (bloating, belly pain, pain during intercourse, pain in the lower back or thighs)
• pelvic pain
• signs of liver problems (e.g., nausea, vomiting, Diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• worsening fibroid symptoms

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Fibristal (Ulipristal).

Do not take Fibristal (Ulipristal) if you:

• are allergic to Fibristal (Ulipristal) or any ingredients of the medication
• are pregnant
• are breast-feeding
• have genital bleeding that is undiagnosed or caused by a condition other than uterine fibroids
• have uterine, cervical, ovarian or Breast Cancer
• have a history of liver disease or active liver disease (determined by increased liver function enzymes in blood tests)

There may be an interaction between Fibristal (Ulipristal) and any of the following:

• Aprepitant
• "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., pentobarbital, Phenobarbital)
• birth control pills
• Bosentan
• Cobicistat
• conivaptan
• Deferasirox
• Diltiazem
• Dronedarone
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• Mitotane
• Modafinil
• progestins (e.g., Cyproterone, Levonorgestrel, medroxyprogesterone, Megestrol)
• protein kinase inhibitors (e.g., Crizotinib, Dabrafenib, imatinib, Nilotinib)
• rifabutin
• rifampin
• St. John's wort
• Sarilumab
• seizure medications (e.g., Carbamazepine, Levetiracetam, Oxcarbazepine, Phenytoin, primidone, Topiramate)
• siltuximab
• Tocilizumab
• Verapamil

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Fibristal (Ulipristal). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Fibristal (Ulipristal).

Asthma: If you have uncontrolled asthma, discuss with your doctor how Fibristal (Ulipristal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fibristal (Ulipristal), and whether any special monitoring is needed.

Birth control: Effective birth control should be practiced while using Fibristal (Ulipristal) as Fibristal (Ulipristal) may harm the baby if used during pregnancy. Birth control pills may be affected by Fibristal (Ulipristal). For this reason, a different method of birth control, such as condoms or a diaphragm should be used. If you become pregnant while taking Fibristal (Ulipristal), contact your doctor immediately.

Liver function: Liver disease or reduced liver function may cause Fibristal (Ulipristal) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Fibristal (Ulipristal) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Fibristal (Ulipristal), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Fibristal (Ulipristal).

Fibristal (Ulipristal) may cause serious liver damage and in rare cases has led to the need for liver transplant. If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately

Menstrual changes: Fibristal (Ulipristal) usually causes a decrease in menstrual bleeding and may cause menstrual bleeding to stop altogether while you are taking Fibristal (Ulipristal). If heavy bleeding continues beyond 10 days of treatment with Fibristal (Ulipristal), contact your doctor. Menstrual periods usually return within 4 weeks of stopping Fibristal (Ulipristal).

Thickened endometrium: Fibristal (Ulipristal) may cause an increase in the thickness of the lining of the uterus (endometrium). Although this thickening usually goes away within several months of stopping treatment, occasionally, it may continue. Your doctor may recommend an ultrasound of your uterus to monitor for any changes.

Pregnancy: If you take Fibristal (Ulipristal) while pregnant, it may cause harm to the developing baby. Do not take Fibristal (Ulipristal) if you are pregnant or not using effective birth control. If you become pregnant while taking Fibristal (Ulipristal), contact your doctor immediately.

Breast-feeding: It is not known if Fibristal (Ulipristal) passes into breast milk. If you are a breast-feeding mother and are taking Fibristal (Ulipristal), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Fibristal (Ulipristal) have not been established for children.

Seniors: The safety and effectiveness of using Fibristal (Ulipristal) have not been established for adults over the age of 65.