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- Clinician Information:
Sotret Patient Information Including Side Effects
Brand Names: Amnesteem, Claravis, Sotret
Generic Name: isotretinoin (oral) (Pronunciation: EYE so TRET i noyn)
- What is isotretinoin (Sotret)?
- What are the possible side effects of isotretinoin (Sotret)?
- What is the most important information I should know about isotretinoin (Sotret)?
- What should I discuss with my healthcare provider before taking isotretinoin (Sotret)?
- How should I take isotretinoin (Sotret)?
- What happens if I miss a dose (Sotret)?
- What happens if I overdose (Sotret)?
- What should I avoid while taking isotretinoin (Sotret)?
- What other drugs will affect isotretinoin (Sotret)?
- Where can I get more information?
What is isotretinoin (Sotret)?
Isotretinoin is a form of vitamin A. It reduces the amount of oil released by oil glands in your skin, and helps your skin renew itself more quickly.
Isotretinoin is used to treat severe nodular acne that has not responded to other treatments, including antibiotics.
Isotretinoin may also be used for purposes not listed in this medication guide.
Accutane 10 mg
oval, pink, imprinted with ACCUTANE 10 ROCHE
Accutane 20 mg
oval, maroon, imprinted with ACCUTANE 20 ROCHE
Accutane 40 mg
oval, yellow, imprinted with ACCUTANE 40 ROCHE
Amnesteem 10 mg
oval, brown, imprinted with I10
Amnesteem 20 mg
oval, white, imprinted with I20
Amnesteem 40 mg
oval, brown, imprinted with I40
Isotretinoin 10 mg-BAR
gray, imprinted with barr, 935
Isotretinoin 20 mg-BAR
brown, imprinted with barr, 935
Isotretinoin 40 mg-BAR
orange, imprinted with barr, 936
What are the possible side effects of isotretinoin (Sotret)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using isotretinoin and call your doctor at once if you have any of these serious side effects:
- depressed mood, trouble concentrating, sleep problems, crying spells, aggression or agitation, changes in behavior, hallucinations, thoughts of suicide or hurting yourself;
- sudden numbness or weakness, especially on one side of the body;
- blurred vision, sudden and severe headache or pain behind your eyes, sometimes with vomiting;
- hearing problems, hearing loss, or ringing in your ears;
- seizure (convulsions);
- severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
- loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- severe diarrhea, rectal bleeding, black, bloody, or tarry stools;
- fever, chills, body aches, flu symptoms, purple spots under your skin, easy bruising or bleeding;
- severe blistering, peeling, and red skin rash; or
- joint stiffness, bone pain or fracture.
Less serious side effects may include:
- joint pain, back pain;
- feeling dizzy, drowsy, or nervous;
- dryness of the lips, mouth, nose, or skin; or
- cracking or peeling skin, itching, rash, changes in your fingernails or toenails.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Sotret (isotretinoin capsules) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about isotretinoin (Sotret)?
Women of child-bearing potential must agree in writing to use two specific forms of birth control and have regular pregnancy tests before, during, and after taking isotretinoin.
Isotretinoin is available only under a special program called iPLEDGE. It is dangerous to try and purchase isotretinoin on the Internet or from vendors outside of the United States.
Do not take vitamin supplements containing vitamin A while you are taking isotretinoin.
Do not donate blood while taking isotretinoin and for at least 30 days after you stop taking it.
Additional Sotret Information
- Sotret Drug Interactions Center: isotretinoin oral
- Sotret Side Effects Center
- Sotret FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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