"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Ethiodol Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Ethiodol (ethiodized oil) Injection is a diagnostic agent used as a radio-opaque medium for hysterosalpingography and lymphography. The brand name of this medication is discontinued, but generic versions may be available. Side effects are uncommon but may include nausea, vomiting, diarrhea, or allergic reactions.
Dosing of Ethiodol is determined by a physician. Ethiodol may interact with other drugs. Tell your doctor all medications and supplements you use. It is unknown if Ethiodol can cause fetal harm when administered to a pregnant woman or if it can affect reproduction capacity. Ethiodol should be administered during pregnancy only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Ethiodol (ethiodized oil) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ethiodol FDA Prescribing Information: Side Effects
Hypersensitivity reactions, foreign body reactions and exacerbation of pelvic inflammatory disease, although infrequent, have been reported. In an occasional patient, abdominal pains may occur. Such pains may be the result of tubal torsion, or possibly due to too rapid a rate of instillation or excessive pressure, or both. The condition is usually only transitory, lasting one or two hours at most, and may be relieved by the administration of any of the commonly used analgesics.
The occasional observation of pulmonary Ethiodol (ethiodized oil) embolization (infarction) several hours after injection has been reported. This was noticed more frequently when excessive amounts of Ethiodol (ethiodized oil) have been injected, in the presence of marked lymphatic obstruction or through accidental intravenous injection. Radiologic manifestations are fine, granular stippling throughout both lung fields. The clinical symptoms usually noted have been mild, consisting of moderate temperature elevation, dyspnea, and cough. However, severe acute symptoms developed in two patients both of whom were severely ill and required extensive care.2 Fuchs3 experienced1 severe and 3 minor complications in a series of 20 bilateral procedures. Two are described by the author as cardiovascular collapse occurring at two hours respectively following the completion of the procedure. It was postulated that minute emboli may have been causative. Recovery was rapid and complete in both instances.
The occurrence of pulmonary invasion may be minimized if radiographic confirmation of intralymphatic (rather than venous) injection is secured, and the procedure discontinued when the medium becomes visible in the thoracic duct or the presence of lymphatic obstruction is noticed.
While rare, other side effects reported include transient fever, lymphangitis, iodism (headache, soreness of mouth and pharynx, coryza and skin rash), allergic dermatitis, and lipogranuloma formation. Delayed wound healing at the site of incision and secondary infection are occasionally seen, and can be prevented or minimized by adhering to a strict sterile technique.
Transient edema or temporary exacerbation of preexisting lymphedema, as well as thrombophlebitis have also been reported. In the extremely rare presence of concomitant lymphatic and inferior vena cava obstruction the contrast medium may be shunted partially to the liver, resulting in hepatic embolization. Also, when accidental intravenous administration of Ethiodol (ethiodized oil) results in a considerable amount of this medium entering the circulation, embolization other than pulmonary may occur as reported in 2 cases4. Both cases developed a transient, psychotic-like manifestation, which in all probability stemmed from the entrance of fine oil droplets into the cerebral circulation. Recovery was uneventful and complete without evidence of neurological sequelae.
Read the entire FDA prescribing information for Ethiodol (Ethiodized Oil) »
Additional Ethiodol Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.