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This document provides essential safety and warning information concerning the use of ketoconazole tablets. Please read carefully and discuss any concerns with your healthcare provider.

• Not for Certain Infections: Ketoconazole tablets are not suitable for treating nail or skin fungal infections or any use not approved by the FDA. Due to the risk of severe side effects, including liver damage and heart issues, this medication is reserved for serious, systemic fungal infections when no safer alternatives are available.

• Liver Damage: There is a significant risk of liver damage while taking ketoconazole tablets, with some cases requiring liver transplantation. Blood tests will be conducted before and during treatment to monitor liver function. Seek immediate medical help if you experience symptoms such as yellowing of the skin or eyes, changes in stool color, dark urine, abdominal swelling, stomach pain, or confusion. Alcohol consumption and concurrent use of other liver-impacting medications increase this risk.

• Heart Rhythm Concerns: The medication may cause potentially fatal heart rhythm issues, such as QT prolongation. Your risk heightens with factors like abnormal electrolyte levels, existing heart rhythm disorders, or concurrent use of other QT-prolonging drugs (e.g., amiodarone, ciprofloxacin). Regular monitoring through electrocardiograms (EKGs) may be conducted. If symptoms like chest pain, palpitations, difficulty breathing, faintness, or lightheadedness occur, contact emergency services immediately.

• Adrenal Insufficiency: Ketoconazole tablets can reduce cortisol levels, leading to adrenal insufficiency. Symptoms include weakness, fatigue, dizziness, appetite loss, and mood changes. Notify your provider if these symptoms emerge to evaluate the continuation of treatment.

• Allergic Reactions: Severe allergic reactions, including anaphylaxis, are possible. If you experience breathing difficulties, facial swelling, rapid heartbeat, dizziness, or a choking sensation, seek medical attention immediately.

• Drug Interactions: Ketoconazole tablets can interact with many medications, including over-the-counter drugs, vitamins, and supplements, potentially leading to dangerous effects. Inform your healthcare provider and pharmacist about all substances you are taking. Notable interactions include medications like alprazolam and statins such as simvastatin and lovastatin.

Contraindications: Ketoconazole tablets should not be used if you have severe liver issues or are taking certain interacting medications. Consult your healthcare provider if these conditions apply to you.

When taking this medication, you may experience some common side effects which are typically mild and manageable. These include nausea, vomiting, diarrhea, constipation, stomach pain, passing gas, dry mouth, tongue discoloration, headache, changes in sleep patterns, dizziness, sensitivity to light, rash, and muscle pain. Some individuals may also notice changes in hair texture, oiliness or dryness of the hair and scalp, or even discoloration. In males, breast growth has been reported. If any of these symptoms persist or worsen, it is advisable to consult with a healthcare provider.

While most users do not encounter serious issues, there are rare but severe side effects that require immediate medical attention. These include symptoms of liver damage such as nausea, vomiting, feeling tired, stomach pain, jaundice, dark urine, and pale stools. Abnormal heart rhythms, known as QT prolongation, indicated by chest pounding, shortness of breath, chest pain, or feeling faint, also warrant urgent care. Extremely low cortisol levels may present as severe weakness, dizziness, weight loss, and loss of appetite. Additionally, a serious allergic reaction might manifest as hives, rash, blistering, skin reddening, swelling of the lips or tongue, and difficulty breathing; these symptoms necessitate prompt medical intervention.

Remember, though serious side effects are rare, awareness and timely action can help mitigate risks. For any other effects not listed, it is important to reach out to a healthcare professional for advice.