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Orimune Side Effects Center
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.
Orimune FDA Prescribing Information: Side Effects
Administration of OPV is associated with a low incidence of paralytic poliomyelitis in vaccinees. Also, individuals in close contact with recently inoculated vaccinees may be at a small risk of developing paralytic poliomyelitis because poliovirus can be shed in the feces (and possibly from the pharynx) for 6-8 weeks after OPV administration. Immunocompromised patients are also susceptible to this adverse reaction. The incidence of poliomyelitis is approximately 1 case per 2.6-5 million doses of OPV administered. Most cases of poliomyelitis
occur after the first dose. The risk of developing paralytic poliomyelitis has also been associated with intramuscular injections of medications received 30 days prior to the onset of paralysis. Intramuscular injections should be avoided for at least 30 days in patients who have received the poliovirus vaccine live oral (OPV) or for 60 days in patients who acquired the disease by contact with vaccine recipients.
In rare cases, Guillain-Barre syndrome has occurred after OPV administration, although a causal relationship has not been established.
Anaphylactic shock has occurred rarely after OPV administration and is manifest as urticaria, pruritus, erythematous skin, conjunctivitis, and sudden or severe fatigue. Cell-mediated, delayed-type allergic reactions (pruritus and rash) also have occurred but are less severe.
Fever can occur in as many as 5% of recipients receiving the injectable form of poliovirus vaccine. Fevers greater than 101.3 degrees F have been reported.
Read the entire FDA prescribing information for Orimune (Oral Poliovirus Vaccine) »
Additional Orimune 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.
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