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Inactive ingredientsanhydrous lactosecroscarmellose sodiumhydroxypropyl methylcellulosemicrocrystalline cellulosemagnesium stearate and purified waterThe peach or light peach film coating contains hydroxypropyl methylcellulosetalctitanium dioxideand synthetic yellow and red iron oxides.

The efficacy endpoints for the two phase 3 trials are shown in Table 14 and Table 15.

DiarrheaDiarrhea is common with XELODA and can sometimes be severeStop taking XELODA and call your doctor right away if the number of bowel movements you have in a day increases by 4 or more than is usual for youAsk your doctor about what medicines you can take to treat your diarrheaIf you have severe bloody diarrhea with severe abdominal pain and fevercall your doctor or go to the nearest emergency room right awayheart problemsXELODA can cause heart problems includingheart attack and decreased blood flow to the heartchest painirregular heartbeatschanges in the electrical activity of your heart seen on an electrocardiogramECGproblems with your heart muscleheart failureand sudden deathStop taking XELODA and call your doctor right away if you get any of the following symptomschest pain shortness of breath feeling faint irregular heartbeats or skipping beats sudden weight gain swollen ankles or legs unexplained tiredness loss of too much body fluiddehydrationand kidney failureDehydration can happen with XELODA and may cause sudden kidney failure that can lead to deathYou are at higher risk if you have kidney problems before taking XELODA and also take other medicines that can cause kidney problemsNauseaand vomiting are common with XELODAIf you lose your appetitefeel weakand have nauseavomitingor diarrheayou can quickly become dehydratedStop taking XELODA and call your doctor right away if youvomit 2 or more times in a dayare only able to eat or drink a little now and thenor not at all due to nauseahave diarrheaSeediarrheaaboveserious skin and mouth reactionsXELODA can cause serious skin reactions that may lead to deathTell your doctor right away if you develop a skin rashblisters and peeling of your skinYour doctor may tell you to stop taking XELODA if you have a serious skin reactionDo not take XELODA again if this happensXELODA can also causehand and foot syndromeHand and foot syndrome is common with XELODA and can cause you to have numbness and changes in sensation in your hands and feetor cause rednesspainswelling of your hands and feetStop taking XELODA and call your doctor right away if you have any of these symptoms and you are not able to do your usual activitiesyou may get sores in your mouth or on your tongue when taking XELODAStop taking XELODA and call your doctor if you get painful rednessswellingor ulcers in your mouth and tongueor if you are having problems eatingTell your doctor if you have any side effect that bothers you or that does not go awayincreased level of bilirubin in your blood and liver problemsIncreased bilirubin in your blood is common with XELODAYour doctor will check you for these problems during treatment with XELODAdecreased white blood cellsplateletsand red blood cell countsYour doctor will do blood tests during treatment with XELODA to check your blood cell counts.

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