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 Mifegymiso. If you are concerned about side effects, discuss the risks and benefits of Mifegymiso with your doctor.

The following side effects have been reported by at least 1% of people taking Mifegymiso. 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.

• breast tenderness
• chills
• Diarrhea
• dizziness
• fatigue
• headache
• hot flushes
• nausea
• vomiting

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 the following side effect occurs:

• Low Blood Pressure (e.g., dizziness, fainting)
• skin rash

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

• hemorrhagic shock (shock from blood loss: dizziness; confusion; rapid breathing and heartbeat; low blood pressure; cool, clammy skin; thirst; Dry Mouth)
• prolonged heavy vaginal bleeding
• signs of a Anaphylaxis (severe allergic reaction) (e.g., itching, rash, Hives; swelling of the face, lips, tongue or throat; difficulty breathing or swallowing)
• signs of a severe skin reaction (e.g., skin peeling, especially around mouth and eyes; red spots which burn, itch, or sting; tender red lumps)
• signs of an infection of the uterus lining (e.g., pain in the lower abdomen, Fever, and abnormal vaginal discharge)
• signs of infection more than 24 hours after taking misoprostol (e.g., nausea, vomiting, diarrhea or unusual weakness)
• signs of Toxic Shock Syndrome (e.g., fever, diarrhea, nausea, vomiting, muscle aches, low blood pressure, confusion, seizures, red spots or rash that looks like a Sunburn)
• worsening asthma symptoms or bronchospasms (e.g., difficulty breathing, coughing, whistling sounds when you breathe, chest tightness).

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 Mifegymiso.

Mifepristone 200 mg
Each white-to-off-white, round, biconvex tablet with "MF" embossed on one side contains 200 mg of mifepristone. Nonmedicinal ingredients: colloidal silica anhydrous, magnesium stearate, maize starch, microcrystalline cellulose, and povidone K30.

Mifepristone is packaged in a PVC/PVDC/Aluminum blister of 1 tablet presented in a green box of one tablet.

Misoprostol 200 µg
Each white, round, flat tablet with "ML" debossed on one side and "200" on the other side contains 200 µg of misoprostol. Nonmedicinal ingredients: hydrogenated castor oil, hypromellose, microcrystalline cellulose, and sodium starch glycolate.

Misoprostol tablets are packaged in dual-faced aluminum blisters and presented in an orange box of 4 tablets.

The two products are provided in two different boxes, which are packed together.

Do not take Mifegymiso if you:

• are allergic to mifepristone, misoprostol, or any ingredients of the medication
• have an Ectopic Pregnancy (a pregnancy developing outside of the uterus)
• have an intrauterine device (IUD) in place
• do not know exactly how far you are into your pregnancy
• have chronic adrenal failure
• are taking long-term corticosteroids
• have a bleeding disorder
• are taking medications to prevent Blood Clots
• have inherited porphyria
• have uncontrolled Asthma.

There may be an interaction between mifepristone - misoprostol and any of the following:

• Abiraterone
• acetylsalicylic acid (Asa)
• alpha blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• amantadine
• Amiodarone
• androgens (e.g., methyltestosterone, nandrolone, testosterone)
• anti-cancer medications (e.g., Cabazitaxel, Docetaxel; Doxorubicin; Etoposide, Ifosfamide, Irinotecan, Vincristine)
• antihistamines (e.g,. cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apixaban
• Apomorphine
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• benzodiazepines (e.g., Chlordiazepoxide, Clonazepam, Diazepam, Lorazepam)
• bexarotene
• birth control pills
• Bisoprolol
• Bosentan
• Bromocriptine
• Buprenorphine
• Bupropion
• Buspirone
• Busulfan
• Calcitriol
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Celecoxib
• chloral hydrate
• chloroquine
• cilostazol
• cisapride
• Colchicine
• conivaptan
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• Dantrolene
• Dapsone
• Deferasirox
• diabetes medications (e.g., chlorpropamide, glipizide, Glyburide, insulin, Metformin, Nateglinide, Rosiglitazone)
• Digoxin
• Disopyramide
• Domperidone
• Dronedarone
• drospirenone
• ergot alkaloids (e.g., Dihydroergotamine, ergonovine,  ergotamine, methylergonovine)
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Ethosuximide
• Everolimus
• Famotidine
• felbamate
• Fentanyl
• Flecainide
• Flutamide
• formoterol
• fosphenytoin
• fosaprepitant
• Galantamine
• GnRH analogs (e.g., Leuprolide, Goserelin)
• Granisetron
• "gliptin" diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Hydrocodone
• Indapamide
• kinase inhibitors (e.g., Dasatinib, imatinib, Nilotinib)
• lidocaine
• lithium
• Lomitapide
• Losartan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Maprotiline
• maraviroc
• Mefloquine
• mestranol
• Methadone
• Metronidazole
• Mirtazapine
• Modafinil
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• Montelukast
• nateglinide
• nefazodone
• nilotinib
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• Ondansetron
• Octreotide
• Oxycodone
• pentamidine
• Perampanel
• Phenobarbital
• Phenytoin
• Pimozide
• praziquantel
• Primaquine
• primidone
• procainamide
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• Propafenone
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• Rivaroxaban
• Romidepsin
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• Repaglinide
• rifabutin
• rifampin
• rilpivirine
• rivaroxaban
• romidepsin
• St. John's wort
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Duloxetine, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., granisetron, ondansetron)
• Sildenafil
• simprevir
• Sirolimus
• Sotalol
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• sulfamethoxazole
• Tacrolimus
• Tamoxifen
• telaprevir
• Temsirolimus
• Teniposide
• Tetrabenazine
• Tetracycline
• Theophylline
• Ticagrelor
• Ticlopidine
• Tizanidine
• Tolterodine
• Tolvaptan
• trabectedin
• Tramadol
• Trazodone
• Trimethoprim
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Vardenafil
• Venlafaxine
• Warfarin
• Zafirlukast
• Zolpidem
• Zopiclone

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 Mifegymiso. 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 Mifegymiso.

Asthma: People with breathing problems may experience increased difficulty breathing when taking misoprostol. It may decrease the effectiveness of corticosteroids or cause tightening of the airways. If you have asthma, discuss with your doctor how Mifegymiso may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mifegymiso, and whether any special monitoring is needed.

Diabetes: The safety and effectiveness of Mifegymiso have not been studied for women with diabetes. Mifegymiso is not recommended for women with diabetes.

Heavy bleeding: Treatment with mifepristone - misoprostol usually results in vaginal bleeding. This is not proof that the pregnancy has been terminated. Complete termination of pregnancy is confirmed at your follow-up appointment with your doctor.

Heavy vaginal bleeding is described as bleeding heavily enough to soak through 2 full-size sanitary pads an hour for 2 hours in a row. This may be a sign that the medication has not worked completely. Contact your doctor immediately if you have heavy vaginal bleeding that lasts more than several hours.

Heart disease: The safety and effectiveness of Mifegymiso have not been established for women with heart disease. Mifegymiso is not recommended for women with heart disease. If you have risk factors for developing heart disease, discuss with your doctor how Mifegymiso may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mifegymiso, and whether any special monitoring is needed.

High blood pressure: The safety and effectiveness of Mifegymiso have not been studied for women with high blood pressure. Mifegymiso is not recommended for women with high blood pressure.

Infection: Rarely, serious and possibly fatal bacterial infections have occurred after taking mifepristone - misoprostol. If you experience abdominal pain or a general feeling of illness more than 24 hours after taking misoprostol, contact your doctor immediately.

Kidney function: The safety and effectiveness of using Mifegymiso have not been determined for women with renal failure. Mifegymiso is not recommended for women with renal failure.

Liver function: The safety and effectiveness of using Mifegymiso have not been determined for women with liver failure. Mifegymiso is not recommended for women with liver failure.

Medical monitoring: It is important to have an appointment with your doctor 7 to 14 days after taking the mifepristone in the doctor's office. This will let your doctor confirm that your pregnancy has safely been terminated.

Seizures: Seizures have been reported with other medications that are similar to misoprostol. If you have a history of seizures, discuss with your doctor how Mifegymiso may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Mifegymiso, and whether any special monitoring is needed.

Treatment failure: Although Mifegymiso is generally effective, there is a possibility it will not work. Babies that are born after failed use of these medications are at an increased risk of birth defects.

Pregnancy: You can become pregnant immediately after using Mifegymiso, and Mifegymiso may cause harm to a developing baby. To decrease the chance of birth defects, avoid becoming pregnant before your next menstrual period.

To avoid becoming pregnant, start using birth control right away.

Breast-feeding: Mifepristone may pass into breast milk. Misoprostol does pass into breast milk. If you are a breast-feeding mother and take mifepristone - misoprostol, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding

Children: The safety and effectiveness of using Mifegymiso have not been established for children less than 15 years of age.