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When considering the use of isotretinoin, it's crucial to understand the associated risks and necessary precautions. Below is a summary of important safety information and warnings:

• Pregnancy Risks: Isotretinoin poses significant risks to unborn babies, including birth defects, miscarriages, and premature births. As a result, it is vital that individuals who can become pregnant avoid using this medication. They must commit to using two reliable forms of contraception for one month before, during, and one month after treatment. Monthly pregnancy tests and counseling are required. In the U.S., this medication is available only through the REMS Program (iPLEDGE), which requires registration by you, your healthcare provider, and your pharmacy. Consult local regulations if you are outside the U.S.

• Mental Health Effects: There is a risk of depression, suicidal thoughts, and other mental health changes when taking isotretinoin. Notify your healthcare provider immediately if you notice mood changes or behavioral issues, especially if you have a history of mental health conditions.

• Increased Brain Pressure: Isotretinoin can increase intracranial pressure, potentially leading to vision loss or even death. Avoid combining isotretinoin with tetracycline antibiotics. Seek immediate medical attention if you experience severe headaches, visual disturbances, nausea, or other neurological symptoms.

• Severe Skin Reactions: Serious skin reactions, including Stevens-Johnson syndrome, may occur. If you develop a severe rash accompanied by fever and breathing difficulties, seek emergency care immediately.

• Pancreatitis: Inflammation of the pancreas is a potential side effect. Contact your healthcare provider if you experience severe abdominal pain, nausea, or fever.

• Cholesterol and Triglycerides: The medication may elevate cholesterol and triglyceride levels. Regular blood tests may be necessary to monitor these levels, and your provider may recommend discontinuing the drug if they become too high.

• Auditory Issues: Discontinue isotretinoin and consult your provider if you experience hearing loss or ringing in the ears, as these symptoms may persist even after stopping the medication.

• Liver Concerns: Isotretinoin can affect liver function. Regular liver function tests are recommended. Alert your healthcare provider if you notice symptoms like jaundice, abdominal pain, or unusual bleeding.

• Gastrointestinal Inflammation: Rare cases of inflammatory bowel disease have been reported. Stop the medication and inform your provider if you experience severe digestive symptoms.

• Bone and Muscle Effects: The drug may cause muscle weakness, joint pain, and bone fractures. This risk is higher in certain populations, such as older adults or those with pre-existing bone conditions. Discuss protective strategies with your healthcare provider.

• Ocular Issues: Vision problems and eye dryness may occur, complicating contact lens use. Exercise caution when driving at night and consult an eye specialist if you experience visual changes.

For any contraindications or if you experience any adverse reactions, consult your healthcare provider immediately. Always discuss the benefits and risks with your doctor before starting isotretinoin.

Common side effects:

• Dry lips, mouth, or skin
• Minor swelling of the eyelids or lips
• Nosebleeds
• Upset stomach
• Thinning hair
• Dry eyes
• Blurry vision
• Cold-like symptoms
• Headaches

Less common but important to monitor:

• Back or joint pain
• Tiredness
• Weight changes
• Poor appetite
• Changes in heartbeat
• Ringing in the ears
• Hair loss

Serious side effects:

• Severe headaches
• Vision changes
• Ringing in the ears
• Hearing loss
• Chest pain
• Yellowing of the eyes or skin
• Dark urine
• Severe diarrhea
• Rectal bleeding
• Serious allergic reactions (rash, severe dizziness, trouble breathing)
• Pancreatitis
• Liver damage
• Mental health changes (depression, suicidal thoughts)
• Neurological issues (seizures, stroke symptoms)

Interactions with high risk of serious adverse effects and should be avoided:

• Tetracyclines (such as Minocycline, tetracycline, doxycycline)
• Vitamin A-type drugs (such as Acitretin, Bexarotene)

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Anti-seizure drugs (such as Phenytoin)
• Corticosteroids (such as Prednisone)
• Contraceptives (including desogestrel, dienogest, drospirenone, ethinylestradiol, and others)