Misoprostol - Contraindications
These conditions, allergies, and situations mean Misoprostol should NOT be used. From the US FDA-approved drug label Section 4.
4 CONTRAINDICATIONS Diclofenac sodium and misoprostol delayed-release tablets are contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac sodium and misoprostol, other prostaglandins, or any components of the drug product [see Warnings and Precautions (5.7 , 5.9) ] • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients [see Warnings and Precautions (5.7 , 5.8) ] • In the setting of coronary artery bypass graft (CABG) surgery [see Warnings and Precautions ] • Pregnancy.
Use of diclofenac sodium and misoprostol delayed-release tablets during pregnancy can result in maternal and fetal harm, including abortion, premature birth, birth defects, and uterine rupture [see Use in Specific Populations ] • Active gastrointestinal bleeding [see Warnings and Precautions ] • Known hypersensitivity to diclofenac, misoprostol or any components of the drug product • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs • In the setting of CABG surgery • Pregnancy • Active gastrointestinal bleeding