What is the most important information I should know about ABSORICA?
ABSORICA can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take ABSORICA.
Patients must not get pregnant:
- for 1 month before starting ABSORICA
- during treatment with ABSORICA
- for 1 month after stopping ABSORICA
If you get pregnant during treatment with ABSORICA, stop taking it right away and call your healthcare provider.
Patients taking ABSORICA must register in the iPLEDGE® Pregnancy Registry at 1-866-495-0654 or www.ipledgeprogram.com. See your healthcare provider for further information.
ABSORICA can cause serious mental health problems, including:
- depression, psychosis (seeing or hearing things that are not real)
- suicide. Some patients taking ABSORICA have had thoughts about hurting themselves or suicide. Consult your healthcare provider if you have such thoughts.
Stop taking ABSORICA and call your healthcare provider right away if you or a family member notices any signs or symptoms of depression or psychosis.
What are the possible side effects of ABSORICA?
ABSORICA can cause serious side effects, including:
- increased pressure in the brain (intracranial hypertension). ABSORICA can increase the pressure in your brain. This can lead to permanent loss of eyesight, and in rare cases, death. Stop taking ABSORICA and call your healthcare provider right away if you get any of these signs of increased brain pressure:
- bad headache
- blurred vision
- dizziness
- nausea or vomiting
- seizures (convulsions)
- stroke
- serious skin problems. Skin rash can occur in patients taking ABSORICA. Sometimes rash can be serious and may lead to death. Stop using ABSORICA and call your healthcare provider right away if you get:
- conjunctivitis (red or inflamed eyes, like “pink eye”)
- rash with a fever
- blisters on legs, arms or face
- sores in your mouth, throat, nose or eyes
- peeling of your skin
- inflammation of your pancreas (pancreatitis) can happen in patients who take ABSORICA and can lead to death. Call your healthcare provider right away if you have any of the following symptoms of pancreatitis:
- severe upper stomach (abdomen) pain
- swelling of your stomach
- nausea and vomiting
- fever
- increased blood fat (lipid) levels. ABSORICA can raise blood fat levels (cholesterol and triglycerides). Your healthcare provider will do blood tests to check your lipids before and during treatment. These problems usually go away when ABSORICA treatment is finished.
- hearing problems. Stop using ABSORICA and call your healthcare provider if your hearing gets worse or if you have ringing in your ears. Your hearing loss may be permanent.
- liver problems, including hepatitis. Your healthcare provider will do tests to check your liver before and during treatment with ABSORICA.
- inflammation of your digestive tract (inflammatory bowel disease). Stop taking ABSORICA and call your healthcare provider.
- bone and muscle problems. Bone problems include bone pain, softening or thinning (which may lead to fractures). Tell your healthcare provider if you plan hard physical activity during treatment with ABSORICA.
Stop ABSORICA and call your healthcare provider right away if you have muscle weakness, which can be a sign of serious muscle damage.
ABSORICA may stop long bone growth in teenagers who are still growing.
- vision problems. Stop taking ABSORICA and call your healthcare provider right away if you have any vision changes. ABSORICA may affect your ability to see in the dark. Some patients get dry eyes during treatment. If you wear contact lenses, you may have trouble wearing them during and after you stop treatment with ABSORICA.
- serious allergic reactions. Stop taking ABSORICA and get emergency medical help right away if you get hives, a swollen face or mouth, or have trouble breathing. Stop taking ABSORICA and call your healthcare provider if you get a fever, rash, or red patches or bruises on your legs.
- blood sugar problems, including diabetes. Tell your healthcare provider if you are very thirsty or urinate more than usual.
The most common side effects of ABSORICA include:
- dry lips
- dry skin
- back pain
- dry eyes
- joint pain
- nose bleeds
- headache
- upper respiratory tract infection (common cold)
- chapped lips or swelling of the lips
- skin reactions
- muscle problems
- eye problems, including decreased vision
These are not all of the possible side effects of ABSORICA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or Sun Pharmaceutical Industries, Inc. at 1-800-818-4555.
What is ABSORICA?
ABSORICA is a prescription medicine used in patients 12 years of age and older for the treatment of severe nodular acne that cannot be cleared up by any other acne treatments, including antibiotics.
Do not change between ABSORICA and ABSORICA LD or other isotretinoin products.
