Common Uses:Off Label Uses:Side Effects:
The side effects of Sotret are
• Sotret can cause birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. See “What
is the most important information I should know about Sotret?”
• Sotret may cause serious mental health problems. See “What is the most important information I should know about Sotret?”
• serious brain problems. Sotret can increase the pressure in your brain. This can lead to permanent loss of eyesight and, in rare cases, death. Stop taking
Sotret and call your doctor right away if you get any of these signs of increased brain pressure:
• bad headache
• blurred vision
• dizziness
• nausea or vomiting
• seizures (convulsions)
• stroke
• stomach area (abdomen) problems. Certain symptoms may mean that your internal organs are being damaged. These organs include the liver, pancreas,
bowel (intestines), and esophagus (connection between mouth and stomach). If your organs are damaged, they may not get better even after you stop taking
Sotret. Stop taking Sotret and call your doctor if you get:
• severe stomach, chest or bowel pain
• trouble swallowing or painful swallowing
• new or worsening heartburn
• diarrhea
• rectal bleeding
• yellowing of your skin or eyes
• dark urine
• bone and muscle problems. Sotret may affect bones, muscles, and ligaments and cause pain in your joints or muscles. Tell your doctor if you plan hard
physical activity during treatment with Sotret. Tell your doctor if you get:
• back pain
• joint pain
• broken bone. Tell all healthcare providers that you take Sotret if you break a bone.
Stop Sotret and call your doctor right away if you have muscle weakness. Muscle weakness with or without pain can be a sign of serious muscle damage.
Sotret may stop long bone growth in teenagers who are still growing.
• hearing problems. Stop using Sotret and call your doctor if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
• vision problems. Sotret may affect your ability to see in the dark. This condition usually clears up after you stop taking Sotret, but it may be permanent.
Other serious eye effects can occur. Stop taking Sotret and call your doctor right away if you have any problems with your vision or dryness of the eyes that
is painful or constant. If you wear contact lenses, you may have trouble wearing them while taking Sotret and after treatment.
• lipid (fats and cholesterol in blood) problems. Sotret can raise the level of fats and cholesterol in your blood. This can be a serious problem. Return to
your doctor for blood tests to check your lipids and to get any needed treatment. These problems usually go away when Sotret treatment is finished.
• serious allergic reactions. Stop taking Sotret and get emergency care right away if you develop hives, a swollen face or mouth, or have trouble breathing.
Stop taking Sotret and call your doctor if you get a fever, rash, or red patches or bruises on your legs.
• blood sugar problems. Sotret may cause blood sugar problems including diabetes. Tell your doctor if you are very thirsty or urinate a lot.
• decreased red and white blood cells. Call your doctor if you have trouble breathing, faint, or feel weak.
• The common, less serious side effects of Sotret are dry skin, chapped lips, dry eyes, and dry nose that may lead to nosebleeds. Call your doctor if you get
any side effect that bothers you or that does not go away.
These are not all of the possible side effects with Sotret. Your doctor or pharmacist can give you more detailed information. Call your doctor for medical advice
about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Cautions / Warnings:Drug Interactions:
It is advisable to inform your physician regarding all prescription and nonprescription drugs you may use, especially of: vitamin A-type drugs (including etretinate and vitamin A itself), tetracyclines (e.g., minocycline), drugs which cause bone loss (e.g., phenytoin, corticosteroids such as prednisone). Avoid use of St John's wort or any other product/drug which may decrease the effectiveness of birth control pills.