| In patients with autosomal dominant polycystic kidney disease (ADPKD), long-term treatment with tolvaptan can rarely cause severe and potentially life-threatening liver injury. |
| This injury is typically hepatocellular, occurs between 3 and 18 months after starting tolvaptan, and resolves within 4 months after stopping the drug. |
| A risk of similar liver injury was not detected following exposure to tolvaptan in non-ADPKD patients. |
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