July 24, 2016
Recommended Topic Related To:


"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"...



Orimune Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/22/2016

Orimune oral poliovirus vaccine (OPV) is an immunization used to prevent polio in infants 6-12 weeks of age, all unimmunized children up to 18 years of age, and high-risk adults. Adults should receive the inactivated poliovirus vaccine (IPV). Orimune is available in generic form. Common side effects of Orimune include fever, pinkeye (conjunctivitis), severe fatigue, injection site reactions (hives, itching, and skin redness), irritability, and loss of appetite.

The adult dose of Orimune is 0.5 mL taken orally initially, then repeated 8 weeks later. The third dose should be given 8-12 months after the second dose. Children up to age 18 years: 0.5 mL orally initially, followed by the second dose preferably 8 weeks after the first dose. The third dose is given 8-12 months after the second dose. Orimune may interact with corticosteroids, alkylating agents, antimetabolites, radiation therapy, and "live" virus vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received. During pregnancy, Orimune should be used only if prescribed. Poliovirus antibodies may be excreted into breast milk, and breastfeeding is not recommended for 2-3 hours before or after inoculation in neonates immunized at birth. Consult your doctor before breastfeeding.

Our Orimune oral poliovirus vaccine (OPV) 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.

Orimune FDA Prescribing Information: Side Effects
(Adverse Reactions)


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.[926] 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)

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.

Women's Health

Find out what women really need.