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Treatment with this drug should be started or restarted in a hospital for proper monitoring. If your level of sodium in the blood is raised too quickly, it may cause a serious (even fatal) condition called osmotic demyelination syndrome. The risk is higher if you have liver disease, poor nutrition, or if you use/abuse alcohol. Tell your doctor right away if you have symptoms such as trouble speaking/swallowing, mental/mood changes (such as confusion), weakness/involuntary movement in the arms/legs, or seizures. Do not use this medication to treat a certain kidney problem (autosomal dominant polycystic kidney disease-ADPKD). Due to the risk of serious liver damage, you must be in a special program for you to take this medication to treat ADPKD. Ask your doctor for details.

Thirst, dry mouth, loss of appetite, constipation, or weakness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Dehydration can occur. The risk is increased if you have vomiting or diarrhea that doesn't stop, and you cannot drink normally. Contact your doctor right away if you notice any symptoms of dehydration, such as fast heartbeat or dizziness/lightheadedness. People with severe liver disease (cirrhosis) may have increased risk of bleeding from the stomach or intestines while taking this medication. Tell your doctor right away if you have any of the following symptoms: black/bloody stools, vomit that contains blood or looks like coffee grounds. Tolvaptan may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, such as: nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

A product that may interact with this drug is: desmopressin. Other medications can affect the removal of tolvaptan from your body, which may affect how tolvaptan works. Examples include azole antifungals (such as ketoconazole, itraconazole), cobicistat, HIV protease inhibitors (such as lopinavir), macrolide antibiotics (such as clarithromycin, erythromycin), ribociclib, rifamycins (such as rifabutin, rifampin), ritonavir, St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.