Medical Editor: John P. Cunha, DO, FACOEP
What Is Ipol?
Ipol (poliovirus vaccine inactivated) is a vaccine used to help prevent the disease polio in children. Ipol works by exposing you to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease.
What Are Side Effects of Ipol?
Common side effects of Ipol include:
- injection site reactions (redness, swelling, tenderness, pain, or a lump),
- fever,
- irritability,
- tiredness,
- drowsiness,
- joint pain,
- body aches, or
- vomiting.
Tell your doctor if you have serious side effects of Ipol including:
- extreme drowsiness,
- fainting,
- seizures (black-out or convulsions), or
- high fever (within a few hours or a few days after the vaccine).
Seek medical care or call 911 at once if you have the following serious side effects:
- Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
- Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
- Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.
Dosage for Ipol
The primary series of Ipol vaccine consists of three 0.5 mL doses administered intramuscularly or subcutaneously, preferably eight or more weeks apart and usually at ages 2, 4, and 6 to 18 months. The first immunization may be administered as early as six weeks of age. A booster dose is administered at 4 to 6 years of age.
What Drugs, Substances, or Supplements Interact with Ipol?
Ipol may interact with steroids, medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders, or medicines to treat or prevent organ transplant rejection. Tell your doctor all medications and supplements you use, and other vaccines you have recently received.
Ipol During Pregnancy and Breastfeeding
During pregnancy, Ipol should be used only when prescribed. It is unknown if this vaccine passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Ipol (poliovirus vaccine inactivated) 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.
SLIDESHOW
25 Ways to Stay Well Abroad in Pictures See SlideshowYou should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with poliovirus is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- extreme drowsiness, fainting;
- a seizure; or
- high fever (within a few hours or a few days after the vaccine).
Common side effects may include:
- redness, pain, swelling, or a lump where the shot was given; or
- fever.
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 vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.
SIDE EFFECTS
Body System As A Whole
In earlier studies with the vaccine grown in primary monkey kidney cells, transient local reactions at the site of injection were observed. (3) Erythema, induration and pain occurred in 3.2%, 1% and 13%, respectively, of vaccinees within 48 hours post-vaccination. Temperatures of ≥39°C (≥102°F) were reported in 38% of vaccinees. Other symptoms included irritability, sleepiness, fussiness, and crying. Because IPV was given in a different site but concurrently with Diphtheria and Tetanus Toxoids and Pertussis Vaccine Adsorbed (DTP), these systemic reactions could not be attributed to a specific vaccine. However, these systemic reactions were comparable in frequency and severity to that reported for DTP given alone without IPV. (12) Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV. (37)
Four additional US studies using IPOL vaccine in more than 1,300 infants, (12) between 2 to 18 months of age administered with DTP at the same time at separate sites or combined have demonstrated that local and systemic reactions were similar when DTP was given alone.
Table 2 (12): Percentage of Infants Presenting with Local or Systemic Reactions at 6, 24, and 48 Hours of Immunization with IPOL Vaccine Administered Intramuscularly Concomitantly at Separate Sites with Sanofi Whole-Cell DTP Vaccine at 2 and 4 Months of Age and with Sanofi Acellular Pertussis Vaccine (Tripedia ) at 18 Months of Age
| REACTION | AGE AT IMMUNIZATION | ||||||||
| 2 Months (n=211) | 4 Months (n=206) | 18 Months† (n=74) | |||||||
| 6 Hrs. | 24 Hrs. | 48 Hrs. | 6 Hrs. | 24 Hrs. | 48 Hrs. | 6 Hrs. | 24 Hrs. | 48 Hrs. | |
| Local, IPOL vaccine alone‡ | |||||||||
| Erythema >1" | 0.5% | 0.5% | 0.5% | 1.0% | 0.0% | 0.0% | 1.4% | 0.0% | 0.0% |
| Swelling | 11.4% | 5.7% | 0.9% | 11.2% | 4.9% | 1.9% | 2.7% | 0.0% | 0.0% |
| Tenderness | 29.4% | 8.5% | 2.8% | 22.8% | 4.4% | 1.0% | 13.5% | 4.1% | 0.0% |
| Systemic§ | |||||||||
| Fever >102.2°F | 1.0% | 0.5% | 0.5% | 2.0% | 0.5% | 0.0% | 0.0% | 0.0% | 4.2% |
| Irritability | 64.5% | 24.6% | 17.5% | 49.5% | 25.7% | 11.7% | 14.7% | 6.7% | 8.0% |
| Tiredness | 60.7% | 31.8% | 7.1% | 38.8% | 18.4% | 6.3% | 9.3% | 5.3% | 4.0% |
| Anorexia | 16.6% | 8.1% | 4.3% | 6.3% | 4.4% | 2.4% | 2.7% | 1.3% | 2.7% |
| Vomiting | 1.9% | 2.8% | 2.8% | 1.9% | 1.5% | 1.0% | 1.3% | 1.3% | 0.0% |
| Persistent Crying | Percentage of infants within 72 hours after immunization was 0.0% after dose one, 1.4% after dose two, and 0.0% after dose three. | ||||||||
| * Sanofi Pasteur Inc. formerly known as Aventis Pasteur Inc. † Children who have been vaccinated with Tripedia vaccine. ‡ Data are from the IPOL vaccine administration site, given intramuscularly. § The adverse reaction profile includes the concomitant use of Sanofi whole-cell DTP vaccine or Tripedia vaccine with IPOL vaccine. Rates are comparable in frequency and severity to that reported for whole-cell DTP given alone. | |||||||||
Digestive System
Anorexia and vomiting occurred with frequencies not significantly different as reported when DTP was given alone without IPV or OPV. (12)
Nervous System
Although no causal relationship between IPOL vaccine and GBS has been established, (28) GBS has been temporally related to administration of another inactivated poliovirus vaccine.
Post-marketing Experience
The following adverse events have been identified during postapproval use of IPOL vaccine. Because these events are reported voluntarily from a population of uncertain size, it may not be possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting or strength of evidence for a causal relationship.
- Blood and lymphatic system disorders: lymphadenopathy
- General disorders and administration site conditions: agitation, injection site reaction including injection site rash and mass
- Immune system disorders: type I hypersensitivity including allergic reaction, anaphylactic reaction, and anaphylactic shock
- Musculoskeletal and connective tissue disorders: arthralgia, myalgia
- Nervous system disorders: convulsion, febrile convulsion, headache, paresthesia, and somnolence
- Skin and subcutaneous tissue disorders: rash, urticaria
Reporting Of Adverse Events
The National Vaccine Injury Compensation Program, established by the National Childhood Vaccine Injury Act of 1986, requires physicians and other healthcare providers who administer vaccines to maintain permanent vaccination records and to report occurrences of certain adverse events to the US Department of Health and Human Services. Reportable events include those listed in the Act for each vaccine and events specified in the package insert as contraindications to further doses of that vaccine. (38) (39) (40)
Reporting by parents or guardians of all adverse events after vaccine administration should be encouraged. Adverse events following immunization with vaccine should be reported by healthcare providers to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Reporting forms and information about reporting requirements or completion of the form can be obtained from VAERS through a tollfree number 1-800-822-7967. (38) (39) (40)
Healthcare providers also should report these events to the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-822-2463.
Read the entire FDA prescribing information for Ipol (Poliovirus Vaccine Inactivated)
© Ipol Patient Information is supplied by Cerner Multum, Inc. and Ipol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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