Dicloenac Sodium And Misoprostol Dr Side Effects

Adverse Reactions The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [see Warnings and Precautions ( 5.2)] GI Bleeding, Ulceration and Perforation [see Warnings and Precautions ( 5.3)] Hepatotoxicity [see Warnings and Precautions ( 5.4)] Hypertension [see Warnings and Precautions ( 5.5)] Heart Failure and Edema [see Warnings and Precautions ( 5.6)] Renal Toxicity and Hyperkalemia [see Warnings and Precautions ( 5.7)] Anaphylactic Reactions [see Warnings and Precautions ( 5.8)] Serious Skin Reactions [see Warnings and Precautions ( 5.10)] Hematologic Toxicity [see Warnings and Precautions ( 5.12)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse reaction information for diclofenac sodium and misoprostol delayed-release tablets is derived from multinational controlled clinical trials in over 2,000 patients receiving diclofenac sodium and misoprostol delayed-release tablets 50 mg/200 mcg or diclofenac sodium and misoprostol delayed-release tablets 75 mg/200 mcg, as well as from blinded, controlled trials of diclofenac sodium delayed-release tablets and misoprostol tablets.

Gastrointestinal GI disorders had the highest reported incidence of adverse reactions for patients receiving diclofenac sodium and misoprostol delayed-release tablets.

These events were generally minor, but led to discontinuation of therapy in 9% of patients on diclofenac sodium and misoprostol delayed-release tablets and 5% of patients on diclofenac sodium.

For GI ulcer rates, [see Clinical Studies ( 14)].

GI disorder Diclofenac Sodium and Misoprostol Delayed-Release Tablets Diclofenac Sodium Abdominal pain 21% 15% Diarrhea 19% 11% Dyspepsia 14% 11% Nausea 11% 6% Flatulence 9% 4% Diclofenac sodium and misoprostol delayed-release tablets can cause more abdominal pain, diarrhea, and other GI symptoms than diclofenac alone.

Diarrhea and abdominal pain developed early in the course of therapy, and were usually self-limited (resolved after 2 to 7 days).

Rare instances of profound diarrhea leading to severe dehydration have been reported in patients receiving misoprostol.

Patients with an underlying condition such as inflammatory bowel disease, or those in whom dehydration, were it to occur, would be dangerous, should be monitored carefully if diclofenac sodium and misoprostol delayed-release tablets are prescribed.

The incidence of diarrhea can be minimized by administering diclofenac sodium and misoprostol delayed-release tablets with food and by avoiding co-administration with magnesium-containing antacids.