Applies to ethanolamine oleate: injectable solution.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your medical caregivers right away if you have:

• fever, chills, cough with yellow or green mucus;

• chest pain, feeling short of breath;

• severe pain or burning in your upper stomach; or

• fluid build-up in or around the lungs--pain when you breathe, feeling short of breath while lying down, wheezing, gasping for breath, cough with foamy mucus, cold and clammy skin, anxiety, rapid heartbeats.

Common side effects may include:

• low fever; or

• trouble swallowing.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to ethanolamine oleate: injectable solution.

Respiratory

Respiratory side effects have included pleural effusion/infiltration (2.1%) and pneumonia (1.2%).^[Ref]

Local

Local side effects have included esophageal ulcer (2.1%) and esophageal stricture (1.3%). Esophagitis, tearing of the esophagus, sloughing of the mucosa overlying the injected varix, ulceration, necrosis, and periesophageal abscess and perforation have also been reported.^[Ref]

General

General side effects have included pyrexia (1.8%) and retrosternal pain (1.6%). Bacteremia has been reported rarely.^[Ref]

Hypersensitivity

Hypersensitivity side effects have rarely included anaphylactic shock.^[Ref]

Renal

Renal side effects have included acute renal failure.^[Ref]

Acute renal failure with spontaneous recovery has been reported in 2 cases following injection of 15 to 20 mL of ethanolamine oleate.^[Ref]

Nervous system

Nervous system side effects have rarely included spinal cord paralysis due to occlusion of the anterior spinal artery.^[Ref]

Hematologic

Hematologic side effects have rarely included disseminated intravascular coagulation.^[Ref]