Isotretinoin in just a single dose can cause severe birth defects or death of a baby. Never use  isotretinoin if you are pregnant or may become pregnant.
You must have a negative pregnancy test before taking isotretinoin. You will also be required to use two forms of birth control to prevent pregnancy while taking this medicine. Stop using isotretinoin and call your doctor at once if you think you might be pregnant.
Before taking this medicine
Isotretinoin can cause miscarriage, premature birth, severe birth defects, or death of a baby if the mother takes this medicine at the time of conception or during pregnancy. Even one dose of isotretinoin can cause major birth defects of the baby's ears, eyes, face, skull, heart, and brain. Never use isotretinoin if you are pregnant.
For Women: Unless you have had your uterus and ovaries removed (total hysterectomy with oophorectomy) or have been in menopause for at least 12 months in a row, you are considered to be of child-bearing potential. You must have a negative pregnancy test before you start taking isotretinoin, before each prescription is refilled, right after you take your last dose of isotretinoin, and again 30 days later. All pregnancy testing is required by the iPLEDGE program.
You must agree in writing to use two specific forms of birth control beginning 30 days before you start taking isotretinoin and ending 30 days after your last dose. Both a primary and a secondary form of birth control must be used together.
Primary forms of birth control include:
tubal ligation (tubes tied);
vasectomy of the male sexual partner;
an IUD (intrauterine device);
estrogen-containing birth control pills (not mini-pills); and
hormonal birth control patches, implants, injections, or vaginal ring.
Secondary forms of birth control include:
a male latex condom with or without spermicide;
a diaphragm plus a spermicide;
a cervical cap plus a spermicide; and
a vaginal sponge containing a spermicide.
Stop using isotretinoin and call your doctor at once if you have unprotected sex, if you quit using birth control, if your period is late, or if you think you might be pregnant. If you get pregnant while taking isotretinoin, call the iPLEDGE pregnancy registry at 1-866-495-0654.
Not having sexual intercourse (abstinence) is the most effective method of preventing pregnancy.
You should not use isotretinoin if you are allergic to it.
Tell your doctor if you have ever had:
depression or mental illness;
asthma;
liver disease;
diabetes;
heart disease or high cholesterol;
osteoporosis or low bone mineral density;
an eating disorder such as anorexia;
a food or drug allergy; or
an intestinal disorder such as inflammatory bowel disease or ulcerative colitis.
You should not breastfeed while using this medicine.
Isotretinoin is not approved for use by anyone younger than 12 years old.
How should I take isotretinoin?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Each prescription of isotretinoin must be filled within 7 days of the date it was written by your doctor. You will receive no more than a 30-day supply of isotretinoin at one time.
Always take isotretinoin with a full glass of water. Do not chew or suck on the capsule. Swallow it whole.
Follow all directions about taking isotretinoin with or without food.
Use  isotretinoin for the full prescribed length of time. Your acne may seem to get worse at first, but should then begin to improve.
You may need frequent blood tests.
Never share this medicine with another person, even if they have the same symptoms you have.
Store at room temperature away from moisture, heat, and light.
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include headache, dizziness, vomiting, stomach pain, warmth or tingling in your face, swollen or cracked lips, and loss of balance or coordination.
