openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: life-threatening or fatal reactions can occur. Resuscitation equipment and personnel should be available ( 5.2 ) Thyroid function test alterations: Oraltag may alter tests which depend on iodine estimation. Perform such tests prior to Oraltag administration ( 5.3 ) 5.1 Risks Associated with Inadvertent Parenteral Administration Oraltag is not a sterile product and is not suitable for a parenteral route of administration. Serious adverse reactions such as sepsis can occur if administered parenterally. Do not administer Oraltag parenterally. 5.2 Hypersensitivity Reactions Administration of Oraltag can cause life-threatening hypersensitivity reactions including anaphylaxis [see Contraindications (4) ] . Patients at increased risk include those with a previous reaction to an iodinated contrast agent and allergic disorders (i.e., bronchial asthma, allergic rhinitis, and food allergies). Emergency resuscitation equipment and trained personnel should be available. 5.3 Alteration of Thyroid Function Tests Iodinated contrast agents may alter the results of thyroid function tests which depend on iodine estimation, e.g., radioactive iodine uptake test. Therefore, such testing, if indicated, should be performed prior to the administration of this preparation.
6 ADVERSE REACTIONS The following adverse reactions are described in greater detail in other sections: Hypersensitivity reactions [see Warnings and Precautions (5.2) ] The most common adverse reactions (incidence < 2%) are nausea, vomiting, and diarrhea ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Interpharma Praha at 1-877-886-7040 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience In studies involving 44 adult and 69 pediatric patients who received oral and intravenous iohexol for CT examinations of the abdomen, two reports of vomiting (2%) were noted. 6.2 Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been reported following oral administration of the dilute, hypotonic solutions of iohexol (9 mgI/mL to 21 mgI/mL): Gastrointestinal: nausea, diarrhea