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The following safety information outlines critical warnings and precautions associated with the use of this medication. It is essential to read carefully and discuss any concerns with your healthcare provider.

• Severe Skin Reactions: In rare cases, individuals may develop severe and potentially life-threatening skin reactions, such as Stevens-Johnson syndrome (SJS), after initiating treatment with griseofulvin. Seek immediate medical attention if you experience a new or severe rash, a rash with fever, unexplained blisters, or new sores in your mouth.

• Serious Liver Issues: Griseofulvin can rarely cause life-threatening liver damage or liver failure. Those with a history or current liver problems are at higher risk. Regular blood tests may be required to monitor liver health. Contact your healthcare provider promptly if you experience unexplained stomach pain, nausea, vomiting, dark urine, pale stools, or jaundice (yellowing of the skin or eyes).

• Pregnancy Warning: Griseofulvin is contraindicated during pregnancy due to reported birth defects and harmful effects shown in animal studies. A pregnancy test may be required before starting treatment. Griseofulvin may reduce the effectiveness of hormonal birth control, so use non-hormonal methods (e.g., condoms, diaphragms, copper IUD) while on this medication. Discontinue use and consult your healthcare provider immediately if you become pregnant.

Contraindications: This medication should not be used if you have any of the following conditions, as it may pose significant health risks:

• Diagnosed with porphyria
• Liver failure
• Pregnancy

Please ensure to consult with your healthcare provider if any of these conditions apply to you before beginning treatment with this medication.

Common side effects:

• Headache
• Nausea
• Vomiting
• Diarrhea
• Upset stomach
• Tiredness
• Dizziness
• Trouble sleeping

Less common but important to monitor:

• Rash or hives
• Oral thrush
• Numbness or tingling in the hands and feet
• Mild confusion

Serious side effects:

• Severe skin reactions (fever, sore throat, painful rash that blisters, body aches)
• Serious liver issues (persistent stomach pain, dark urine, nausea, yellowing of the skin or eyes)
• Signs of infection (sore throat that doesn’t improve, fever)
• Symptoms indicating kidney problems (changes in urine output)
• Very serious allergic reaction (rash, severe dizziness, trouble breathing, swelling of the face, tongue, or throat)

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

• Phenobarbital
• Warfarin