Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
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%), retrosternal 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.
WARNINGS ETHAMOLlN Injection should be used in pregnant women only when clearly needed (see PRECAUTIONS).
The practice of injecting varicosities of the leg with ETHAMOLlN Injection is not supported by adequately controlled clinical trials.
Therefore, such use is not recommended.
Like all medications, Ethamolin can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: