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The safety information for modafinil (Provigil) is crucial for ensuring your well-being while using this medication. Please carefully consider the following warnings and consult your healthcare provider if you have any concerns or questions.

• Serious Allergic Reactions: Although infrequent, modafinil (Provigil) can trigger severe allergic reactions, which may include swelling of the face, eyes, lips, tongue, or throat, potentially leading to breathing difficulties. Other affected areas can include the liver or blood cells. Symptoms such as fever, rash, weakness, and yellowing of the skin or eyes typically appear between two weeks to a month after initiating treatment. Seek immediate medical assistance if you experience any of these symptoms. This risk is elevated for individuals with a prior allergic reaction to modafinil (Provigil).

• Severe Skin Reactions: Rare but serious skin conditions, including Stevens-Johnson syndrome (SJS) and Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, can occur with modafinil (Provigil). Discontinue use and seek urgent medical care if you develop a new rash, sores, blisters, or peeling skin on your body, lips, or in your mouth.

• Driving and Alertness: Modafinil (Provigil) may alter your ability to concentrate, think, or react. While it promotes wakefulness, extreme sleepiness may persist. Refrain from activities requiring alertness, such as driving or operating machinery, until you are aware of how the medication affects you. The risk of impairment increases with alcohol consumption or if taken with other medications that reduce alertness.

• Cardiac Concerns: Some individuals may experience chest pain, irregular heartbeat, or shortness of breath while on modafinil (Provigil), particularly those with pre-existing heart conditions. Monitoring blood pressure and heart rate may be recommended. Discuss with your healthcare provider if you have a history of heart problems.

• Mental Health Symptoms: Modafinil (Provigil) has been associated with mental health symptoms, including depression, hallucinations, mania, or suicidal thoughts. Monitor for any aggravation of depression or unusual mood or behavior changes. Those with a history of mental health issues should exercise caution.

Contraindications:

• Do not use modafinil (Provigil) if you have a known allergy to armodafinil (Nuvigil). Consult your healthcare provider if this applies to you before starting modafinil (Provigil).

This information is intended to help ensure your safety and optimize the therapeutic effects of your treatment. Always consult your healthcare provider for personalized medical advice.

Common side effects:

• Headache
• Nausea
• Nervousness
• Runny nose
• Back pain
• Diarrhea
• Anxiety
• Dizziness
• Upset stomach
• Indigestion
• Trouble sleeping

Less common but important to monitor:

• Loss of appetite
• Dry mouth
• Sore throat
• Chest pain
• High blood pressure
• Fast heartbeat

Serious side effects:

• Suicidal thoughts or behaviors
• Mental health changes (worsening depression, anxiety, mania, hallucinations, agitation)
• Heart problems (chest pain, irregular heartbeat, trouble breathing)
• Severe skin reactions (fever, tiredness, sore throat, eye discomfort, cough, body aches, rash, blisters, skin peeling)
• Allergic reactions (fever, swollen lymph nodes, rash, itching, swelling of the face, tongue, or throat, severe dizziness, trouble breathing)

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

• Hormonal birth control (such as pills, patches, or rings)
• Armodafinil

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

• Clomipramine
• Cyclosporine
• Ospemifene
• Triazolam
• Alfentanil
• Amiodarone
• Avapritinib
• Axitinib
• Bosutinib
• Daridorexant
• Elacestrant
• Mavacamten
• Quizartinib
• Revumenib

Interactions with low risk that usually do not require a change in therapy:

• Caffeine