Emtricitabine and Tenofovir (Oral Route)

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Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blisters under the skin
• Hives or welts
• Itching skin
• Rash with flat lesions or small raised lesions on the skin
• Redness of the skin
• Spots on your skin resembling a blister or pimple
• Skin rash

• Blindness or vision changes
• Burning of the face or mouth
• Burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings in the hands, arms, feet, or legs
• Chest pain
• Clumsiness or unsteadiness
• Sensation of pins and needles
• Sneezing
• Sore throat
• Stabbing pain
• Weakness in the hands or feet

• Abdominal or stomach discomfort
• Agitation
• Bloating
• Bloody or cloudy urine
• Bone pain
• Chills
• Coma
• Confusion
• Constipation
• Convulsions or seizures
• Cough
• Darkened urine
• Decreased appetite
• Decreased frequency or amount of urine
• Depression
• Diarrhea
• Difficult or labored breathing
• Difficult or painful urination
• Difficulty with swallowing
• Dizziness
• Fast heartbeat
• Fast, shallow breathing
• Fever
• General feeling of discomfort
• Headache
• Hostility
• Increase in the amount of urine
• Increased blood pressure
• Increased thirst
• Indigestion
• Irritability
• Lethargy
• Loss of appetite
• Lower back or side pain
• Muscle pain or cramping
• Muscle twitching
• Nausea
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid weight gain
• Sleepiness
• Shortness of breath
• Stupor
• Sudden decrease in the amount of urine
• Swelling of the face, fingers, hands, lower legs, or ankles
• Tightness in the chest
• Trouble with breathing
• Unusual tiredness or weakness
• Vomiting
• Weight gain
• Wheezing
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Lack or loss of strength
• Passing of gas
• Weight loss

• Acid or sour stomach
• Back pain
• Belching
• Difficulty with moving
• Discouragement
• Feeling sad or empty
• Heartburn
• Increased cough
• Joint pain
• Lack of appetite
• Loss of interest or pleasure
• Muscle aching or cramping
• Muscle pain or stiffness
• Pain
• Runny nose
• Shortness of breath
• Sleeplessness
• Stomach discomfort, upset, or pain
• Stuffy nose
• Sweating
• Swollen joints
• Tiredness
• Trouble concentrating
• Trouble sleeping
• Unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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