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Individuals previously sensitized to trypsin, pancreatin or pancrelipase may have allergic manifestations.

Carcinogenesis, Mutagenesis

Long-term studies in animals have not been performed to evaluate the carcinogenic potential.


Category C: Animal reproduction studies have not been conducted with VIOKASE® (pancrelipase tablets, powder) . It is also not known whether VIOKASE® (pancrelipase tablets, powder) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. VIOKASE® (pancrelipase tablets, powder) should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when pancrelipase is administered to a nursing mother.

Last reviewed on RxList: 12/9/2008
This monograph has been modified to include the generic and brand name in many instances.


Report Problems to the Food and Drug Administration


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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