GastroMARK Side Effects

Please note - some side effects for GastroMARK may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

GastroMARK Side Effects - for the Professional

GastroMARK

GastroMARK was evaluated in 256 patients and normal volunteers in clinical trials. Of these, 147 (57%) had at least one adverse event. Deaths did not occur during the study period of 7 days. In 15/256 (6%) patients, the ingestion of GastroMARK was either interrupted or stopped because of vomiting or because they could not ingest any more fluid. One normal volunteer had prolonged abdominal cramping for 4 hours. One patient had post-operative ileus 2 days after ingesting GastroMARK.

There is a suggestion of differences in rates of adverse experiences in patients who have or do not have pancreatic or gastric masses. In patients with gastric or pancreatic masses, vomiting was reported in 4/35 (11%); in patients without gastric or pancreatic masses, vomiting was reported in 10/221 (5%) (p = 0.07). Abdominal pain was reported in 1/35 (3%) of patients with pancreatic or gastric masses and in 22/221 (10%) of patients without these lesions. The clinical relevance of these findings is not known.

The following table of adverse events is based upon clinical trials with GastroMARK in 256 subjects. 

In the safety database of 256 people, the type of events was similar in people of each gender and in patients and healthy volunteers. The sample size was too small to determine whether there is any association of adverse events to body weight. However, for nausea and diarrhea, as shown in the following table, the rate of adverse events was much higher in women, both in patients and in volunteers.

Other events reported in less than 0.5% of 256 healthy volunteers and patients who received GastroMARK are: chills, fever, post-operative ileus, eructation, itching, urticarial rash, pustular rash, stomatitis, taste alteration, and edema of extremities. One healthy volunteer had prolonged abdominal cramping for 4 hours.

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