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Cialis ® (tadalafil) tablets
2.5 mg, 5 mg, 10mg, 20 mg tablets
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Can Cialis® (tadalafil) tablets be crushed or split?
Cialis (tadalafil) tablets should not be split, crushed, or separated in any way; the entire dose should be taken.
Detailed Information
Tadalafil tablets are manufactured as an unscored, intact dosage form and are practically insoluble in water and very slightly soluble in ethanol. Tadalafil tablets should not be split and entire dose should be taken.1
Splitting or crushing tadalafil tablets may result in a patient receiving more or less than the prescribed dose. Data are not available to support any alternative dosing options beyond specific dosing/administration according to the approved tadalafil label.
Food and Drug Administration Guidance on Tablet Splitting
The FDA advises against tablet splitting unless it is specified in the drug’s labeling. In addition, the American Medical Association and other medical organizations also advise against tablet splitting.2
If a tablet is approved by the FDA to be split, this information will be printed in the “HOW SUPPLIED” section of the professional label insert and in the patient package insert. In addition, the tablet will be scored with a mark indicating where to split it.2,3
If labeling does not include such information, the FDA has not evaluated the tablet to ensure that, if split, the 2 halves are the same in weight or drug content or work the same way in the body as the whole tablet.3
Enclosed Prescribing Information
References
1Cialis [package insert]. Indianapolis, IN: Eli Lilly and Company; 2018.
2Food and Drug Administration. Tablet splitting: a risky practice. Published July 21, 2009. Updated July 25, 2017. Accessed January 5, 2023. https://wayback.archive-it.org/7993/20170722185651/https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm171492.htm
3Food and Drug Administration. Best practices for tablet splitting. Updated August 23, 2013. Accessed January 5, 2023. https://www.fda.gov/drugs/ensuring-safe-use-medicine/best-practices-tablet-splitting
Date of Last Review: January 05, 2023