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Use of ADDYI and alcohol increases the risk of severe hypotension and syncope; therefore, alcohol use is contraindicated. Before prescribing 2021-01-28 Flibanserin can cause drowsiness, dizziness, and fainting, especially when used with alcohol. Do not drive or operate heavy machinery until you know how flibanserin affects you. This medication is only available through the Addyi risk evaluation and mitigation strategy (REMS) Program because of the increased risk of severe low blood pressure and fainting (loss of consciousness) with alcohol use. Addyi Warnings. Drinking alcohol close to the time that you take flibanserin can increase the risk of severe low blood pressure and fainting. If you drink one or two alcoholic drinks in the evening, you must wait at least 2 hours before taking flibanserin at bedtime.

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Fliban 100mg Warning. Flibanserin has been classified by the US FDA as US FDA pregnancy category Not Assigned. There are no controlled data in human pregnancy. There are no studies of Flibanserin tablets in pregnant women to inform whether there is a drug-associated risk in humans. ADDYI (flibanserin) tablets, for oral use Initial U.S. Approval: 2015 WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS See full prescribing information for complete boxed warning. Use of ADDYI ADDYI (flibanserin) Page 2 of 44 RECENT MAJOR LABEL CHANGES 1 Indications, 2 Contraindications, 3 Serious Warnings and Precautions Box, 4 Dosage and Administration, 7 Warnings and Precautions, 8 Adverse Reactions, 14 Clinical Trials 01/2021 TABLE OF CONTENTS The FDA requires all potential medication risks for ADDYI (flibanserin tablet, film coated) be disclosed to consumers, no matter how rare. Here are the warnings and precautions for ADDYI.

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Flibanserin can cause very low blood pressure, causing dizziness, lightheadedness, and fainting. Tell your doctor if you have or have ever had liver disease or if you drink or have ever drunk large amounts of alcohol.

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This is a relatively new medicine. Take this medication by mouth as directed by your doctor, usually once daily at bedtime. Take flibanserin only at bedtime to reduce your risk of low blood pressure, fainting, and drowsiness while you are awake. After taking flibanserin, do not drink any alcohol until the next day. See also Warning section. See Full Prescribing Information and Medication Guide, including Boxed Warning regarding hypotension and syncope in certain settings at addyi.com/pi.

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Flibanserin causes drowsiness and reduces alertness. Find everything you need to know about Flibanserin (Addyi), including what it is used for, warnings, reviews, side effects, and interactions. Learn more about Flibanserin (Addyi) at EverydayHealth ADDYI (flibanserin) tablets, for oral use Initial U.S. Approval: 2015 WARNING: HYPOTENSION AND SYNCOPE IN CERTAIN SETTINGS See full prescribing information for complete boxed warning. • Use of ADDYI and alcohol together close in time increases the risk of severe hypotension and syncope.

The FDA is requiring a safety labeling change  but agreed to dampen the strong warning on the basis of postmarketing data. Addyi, known chemically as flibanserin, is designed for premenopausal women  See the “Flibanserin Precautions” section. Common side effects of flibanserin include the following: dizziness; nausea  Addyi® (flibanserin).
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Do not take Addyi if you are allergic to flibanserin or any ingredients contained in this drug Flibanserin can lower your blood pressure, which can make you dizzy.