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Ethamolin (Ethanolamine Oleate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The reported frequency of complications/adverse events per injection session was 13%. The most common complications were pleural effusion/infiltration (2.1%), esophageal ulcer (2.1 %), pyrexia (1.8%), retrosterual pain (1.6%), esophageal stricture.(1.3%), and pneumonia (1.2%).

Other adverse local esophageal reactions have also been reported at rates of 0.1 to 0.4%, including esophagitis, tearing of the esophagus, sloughing of the mucosa overlying the injected varix, ulceration, stricture, necrosis, periesophageal abscess and perforation (see PRECAUTIONS). These complications appear to be dependent upon the dose and the patient's clinical state.

Bacteremia has been observed in patients following injection of esophageal varices with ETHAMOLlN. Pyrexia and retrosternal pain are not infrequently observed during the post-injection period. Fatal aspiration pneumonia has occurred in patients with esophageal varices who underwent ETHAMOLIN Injection Sclerotherapy (see PRECAUTIONS). Anaphylactic shock and acute renal failure with spontaneous recovery have occurred (see PRECAUTIONS). A case of disseminated intravascular coagulation has been reported.

Spinal cord paralysis due to occlusion of the anterior spinal artery has been reported in one child eight hours after ETHAMOLIN sclerotherapy.

Drug label data at the top of this Page last updated: 2013-04-23

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