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This medication comes with important safety information that you should consider before use. Below are key points to be aware of, and it is advised to discuss any concerns with your healthcare provider.

• Hepatitis B Worsening: If you have both HIV and Hepatitis B, do not abruptly discontinue this medication, as it may lead to severe hepatitis B symptoms. Prior to starting this medication, a test for Hepatitis B is required. Should discontinuation be necessary, regular liver monitoring will be needed. Report any symptoms such as fever, fatigue, nausea, vomiting, dark urine, pale stool, or jaundice immediately.

• Lactic Acidosis and Liver Damage: Rare but potentially life-threatening conditions such as lactic acidosis and liver damage have been associated with this medication. Symptoms include loss of appetite, abdominal pain, muscle pain, rapid breathing, extreme tiredness, and sudden weakness. If these occur, stop the medication and seek emergency medical assistance. Risks are higher for females and those with obesity.

• Kidney Problems: The component tenofovir may cause or worsen kidney issues. Avoid using high doses of NSAIDs like ibuprofen and naproxen concurrently. Regular kidney function tests may be necessary. Seek medical attention if you notice symptoms like bone pain, leg or foot pain, frequent fractures, or muscle pain.

• Mental Health Effects: Efavirenz can cause mood alterations, including depression, suicidal thoughts, anger, or hallucinations. Any mood changes should be reported to your healthcare provider. Immediate help is required if you experience thoughts of self-harm or harming others.

• Central Nervous System Effects: Efavirenz may lead to dizziness, insomnia, concentration difficulties, drowsiness, or unusual dreams, especially during the first month. If these issues persist or interfere with your daily routine, consult your healthcare provider.

• Rash: A rash may develop within the first two weeks of treatment. While typically mild and resolving in a month, severe reactions like fever or blistering require immediate cessation of the medication and medical attention.

• Liver Toxicity: Serious liver damage can occur, particularly in individuals with existing liver conditions or infections. Liver health will be monitored through lab tests. Symptoms of liver damage, such as fatigue, nausea, vomiting, dark urine, pale stool, abdominal pain, and jaundice, necessitate immediate medical consultation.

• Pancreatitis: Some patients, especially children with past NRTI use or a history of pancreatitis, may develop pancreatitis. If symptoms like abdominal pain radiating to the back, nausea, vomiting, rapid heartbeat, or fever occur, discontinue the medication and seek medical assistance.

• Immune Reconstitution Syndrome: This medication might trigger inflammation due to immune recovery. Pre-existing infections need evaluation and possible treatment before starting the medication. Contact your healthcare provider for symptoms like fever, breathing difficulties, or sudden health changes.

• Contraindications: Do not use this medication if you are taking elbasvir/grazoprevir (Zepatier), as it can pose serious health risks.

Always consult with your healthcare provider for personalized advice and before making any changes to your medication regimen.

Common side effects:

• dizziness
• trouble sleeping
• drowsiness
• unusual dreams
• difficulty concentrating
• tiredness
• headaches
• diarrhea

• rash

  Less common but important to monitor:

• changes in body fat distribution

• bone loss

  Serious side effects:

• mental or mood changes like depression or suicidal thoughts
• severe headaches
• unexplained weight loss
• muscle aches
• vision changes
• severe allergic reactions like blistering rash, severe dizziness, or difficulty breathing
• liver issues such as persistent nausea, vomiting, dark urine, and yellowing skin or eyes
• symptoms of pancreatitis like severe stomach pain
• Guillain-Barre syndrome
• high blood acid levels symptoms like muscle pain, severe stomach discomfort, or changes in heartbeat

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

• Orlistat
• Sorbitol
• Drugs that may affect the kidneys (including Adefovir, Cidofovir, aminoglycosides such as Amikacin/gentamicin)
• Other products that treat HIV infection
• Products that contain Efavirenz, Lamivudine, or tenofovir

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

• St. John's wort
• Some drugs used to treat seizures (such as Carbamazepine)
• Atazanavir
• Atovaquone/proguanil
• Azole antifungals (such as Voriconazole)
• Bedaquiline
• Cabotegravir
• Cobicistat
• Elbasvir/grazoprevir
• Elvitegravir
• Macrolide antibiotics (such as Clarithromycin)
• Rilpivirine
• Sofosbuvir/velpatasvir
• Hormonal birth control (such as pills, patch, or ring)

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

• Alcohol
• Marijuana (cannabis)
• Antihistamines (such as Cetirizine, diphenhydramine)
• Drugs for sleep or anxiety (such as Diazepam, Zolpidem)
• Muscle relaxants
• Opioid pain relievers (such as codeine)