Emtricitabine, Rilpivirine, 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:

• Discouragement
• Feeling sad or empty
• Irritability
• Lack of appetite
• Loss of interest or pleasure
• Mental depression
• Thoughts of killing oneself
• Tiredness
• Trouble concentrating
• Trouble sleeping

• Body aches or pain
• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• Chest pain
• Cough
• Difficulty with breathing
• Ear congestion
• Fever or chills
• Headache
• Loss of voice
• Runny or stuffy nose
• Shortness of breath
• Sneezing
• Sore throat
• Tightness in the chest
• Troubled breathing
• Unsteadiness or awkwardness
• Unusual tiredness or weakness
• Weakness in the arms, hands, legs, or feet
• Wheezing

• Abdominal or stomach discomfort
• Agitation
• Bloating
• Bloody or cloudy urine
• Bone pain
• Broken bones, especially the thigh bone
• Changes in behavior
• Confusion
• Constipation
• Dark urine
• Decreased appetite
• Decrease in amount of urine
• Diarrhea
• Difficulty with swallowing
• Dizziness
• Dry mouth
• Fast heartbeat
• Fast, shallow breathing
• Frequent urination
• General tiredness and weakness
• Headache
• Hives
• Hostility
• Increased thirst
• Indigestion
• Irritability
• Itching
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Lethargy
• Light-colored stools
• Loss of appetite
• Muscle pain or cramps
• Muscle tenderness, wasting, or weakness
• Nausea or vomiting
• Numbness or tingling in the hands, feet, or lips
• Pain in the stomach, side, or abdomen, possibly radiating to the back
• Rapid weight gain
• Seizures
• Skin rash
• Sleepiness
• Swelling of the face, ankles, hands, feet, or lower legs
• Upper right stomach pain
• Vomiting
• 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:

• Abnormal dreams
• Sleeplessness
• Trouble sleeping
• Unable to sleep

• Acid or sour stomach
• Back pain
• Belching
• Difficulty with moving
• Heartburn
• Pain in the joints
• Pain or tenderness around the eyes and cheekbones
• Sneezing
• Stomach discomfort or upset

• Lack or loss of strength

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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