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 Orilissa (Elagolix). If you are concerned about side effects, discuss the risks and benefits of Orilissa (Elagolix) with your doctor.

The following side effects have been reported by at least 1% of people taking Orilissa (Elagolix). 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.

• Constipation
• decreased interest in sexual activity
• Diarrhea
• dizziness
• headache
• hot flashes
• joint pain
• nausea
• night sweats
• stomach pain
• trouble sleeping
• weight gain

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:

• anxiety
• increased frequency of cold symptoms (e.g., runny or stuffy nose, sore throat)
• irritability
• menstrual changes (e.g., irregular bleeding, change in bleeding, no bleeding)
• mood changes
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• 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)
• sinus infections

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

• thoughts of suicide or self-harm

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 Orilissa (Elagolix).

150 mg
Each light pink, oblong tablet, debossed with EL 150 on one side, contains 155.2 mg of Orilissa (Elagolix) sodium, equivalent to 150 mg Orilissa (Elagolix). Nonmedicinal ingredients: armine high tint, magnesium stearate, mannitol, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium carbonate monohydrate, talc, and titanium dioxide.

200 mg
Each light orange, oblong tablet, debossed with EL 200 on one side, contains 207 mg of Orilissa (Elagolix) sodium, equivalent to 200 mg Orilissa (Elagolix). Nonmedicinal ingredients: iron oxide red, magnesium stearate, mannitol, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium carbonate monohydrate, talc, and titanium dioxide.

Do not take Orilissa (Elagolix) if you:

• are allergic to Orilissa (Elagolix) or any ingredients of the medication
• are or may become pregnant
• have unexplained vaginal bleeding
• have Osteoporosis
• have severely decreased liver function
• are taking certain medications such as Cyclosporine or Gemfibrozil

There may be an interaction between Orilissa (Elagolix) and any of the following:

• Aliskiren
• Amiodarone
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• antihistamines (e.g. bilastine, cetirizine, Loratadine)
• birth control pills
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Carvedilol
• certain cancer medications (e.g., brentuximab, Daunorubicin, Doxorubicin, Etoposide, Idarubicin, Methotrexate, Mitotane, Vinblastine, Vincristine)
• Cimetidine
• Clobazam
• Clozapine
• Cobicistat
• Colchicine
• conivaptan
• cyclosporine
• dabigatran
• Dexamethasone
• Digoxin
• Dronedarone
• Edoxaban
• Eltrombopag
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• gemfibrozil
• "gliptin" Diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• grapefruit juice
• Hepatitis C antivirals (e.g. daclatasvir, glecaprevir, grazoprevir ledipasvir, ombitasvir, paritaprevir, velpatasvir, voxilaprevir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
• Hydrocortisone
• Idelalisib
• Leflunomide
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• midazolam
• mifepristone
• Omeprazole
• Nadolol
• Naloxegol
• Paliperidone
• Phenobarbital
• Phenytoin
• primidone
• protein kinase inhibitors (e.g., Bosutinib, Crizotinib, Dabrafenib, imatinib, Pazopanib)
• Prucalopride
• quinidine
• quinine
• rifampin
• Risperidone
• Romidepsin
• Silodosin
• Sirolimus
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Stiripentol
• Tacrolimus
• Teriflunomide
• Tolvaptan

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 Orilissa (Elagolix). 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 Orilissa (Elagolix).

Birth control: It is possible to become pregnant while taking Orilissa (Elagolix). Women taking Orilissa (Elagolix) should use effective methods of birth control that do not contain estrogen while taking Orilissa (Elagolix) and for at least 1 week after the last dose.

Bone health: Orilissa (Elagolix) can cause a decrease in the density of bones. Higher doses taken for longer periods of time increase the amount of bone lost. The lowest dose of Orilissa (Elagolix) to control the symptoms, taken for the shortest period of time, is less likely to cause these problems. If you have risk factors for osteoporosis, such as previous use of other medications that decrease bone density, metabolic bone disease, anorexia, long term use of alcohol or tobacco, or family history of osteoporosis, discuss with your doctor whether any special monitoring is needed.

Depression and suicidal behaviour: Orilissa (Elagolix) can cause mood swings and symptoms of depression. People taking Orilissa (Elagolix) may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. Symptoms of depression such as poor concentration, changes in weight, changes in sleep, and decreased interest in activities may also occur. If you experience these side effects or notice them in a family member who is taking Orilissa (Elagolix), contact your doctor immediately. Your doctor should closely monitor your emotional and behavioural changes while taking Orilissa (Elagolix).

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

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.

Pregnancy: The use of Orilissa (Elagolix) may cause miscarriage or other complications if the mother takes it during pregnancy. If you become pregnant while taking Orilissa (Elagolix), contact your doctor immediately.

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

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

Seniors: Orilissa (Elagolix) has not been studied in women over 65 years of age. It is not intended for use by women who have reached Menopause.