Tolvaptan (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:

• Abdominal or stomach pain
• Blurred vision
• Dry mouth
• Flushed, dry skin
• Frequent urination
• Fruit-like breath odor
• Increased hunger
• Increased thirst
• Increased urination
• Increased volume of pale, dilute urine
• Nausea
• Sweating
• Thirst
• Troubled breathing
• Unexplained weight loss
• Unusual tiredness or weakness
• Vomiting

• Abdominal or stomach tenderness
• Anxiety
• Blood in the urine
• Bloody stools
• Blue lips, fingernails, or skin
• Bruising
• Chest pain
• Confusion
• Cough
• Coughing or vomiting blood
• Dark-colored urine
• Dizziness or lightheadedness
• Fainting
• Fast, slow, irregular or shallow heartbeat
• Fever
• Irregular, fast or slow, or shallow breathing
• Loss of consciousness
• Muscle cramps or spasms
• Muscle pain or stiffness
• Pain, redness, or swelling in the arm or leg
• Persistent bleeding or oozing from puncture sites, mouth, or nose
• Pink or red urine
• Rash
• Rectal bleeding
• Shortness of breath
• Sudden shortness of breath or troubled breathing
• Sweating
• Vaginal bleeding

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:

• Difficulty having a bowel movement (stool)
• Lack or loss of strength

• Loss of appetite
• Weight loss

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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