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Ipol

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Ipol

Ipol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Ipol (poliovirus vaccine inactivated) is used to help prevent the disease polio in children. It is a vaccine that 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. Common side effects include redness/swelling/tenderness at the injection site, fever, irritability, and tiredness.

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. 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. During pregnancy, Ipol should be used only when prescribed. It is unknown if this vaccine passes into breast milk. Consult your doctor before breastfeeding.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ipol in Detail - Patient Information: Side Effects

You 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 polio vaccine 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 any of these serious side effects:

  • extreme drowsiness, fainting;
  • seizure (black-out or convulsions); or
  • high fever (within a few hours or a few days after the vaccine).

Less serious side effects include:

  • redness, pain, swelling, or a lump where the shot was given;
  • low fever;
  • joint pain, body aches;
  • drowsiness; or
  • vomiting.

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.

Read the entire detailed patient monograph for Ipol (Poliovirus Vaccine Inactivated) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Ipol Overview - Patient Information: Side Effects

SIDE EFFECTS: Redness/swelling/tenderness at the injection site, fever, irritability, and tiredness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact the doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may call Health Canada at 1-866-234-2345.

Read the entire patient information overview for Ipol (Poliovirus Vaccine Inactivated)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ipol FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 212: 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%
¶ Sanofi Pasteur Inc. formerly known as Aventis Pasteur Inc.
§ 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.
† Children who have been vaccinated with Tripedia vaccine.

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 health-care 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.38-40

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 toll-free number 1-800-822-7967.38-40

Health-care providers also should report these events to the Pharmacovigilance Department, Sanofi Pasteur Inc., Discovery Drive, Swiftwater, PA 18370 or call 1-800-8222463.

Read the entire FDA prescribing information for Ipol (Poliovirus Vaccine Inactivated) »

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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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