"European Union (EU) regulators have recommended market approval of a combination bacterial and viral vaccine (Vaxelis, Sanofi Pasteur) that immunizes children against six different disorders.
The new injectable vaccine is indic"...
Imovax Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Imovax Rabies Vaccine is an immunization used to prevent rabies in people who have been bitten by an animal or otherwise exposed to the rabies virus. Common side effects of Imovax Rabies Vaccine include pain, swelling, itching, or redness at the injection site, headache, dizziness, muscle pain, nausea, or stomach pain.
The usual dose of Imovax for pre-exposure vaccination is six intramuscular injections, or 5 doses of Imovax plus one injection of Rabies Immune Globulin (RIG). Post-exposure vaccination is 2 injections in a person who has had the pre-exposure vaccinations. Post-exposure in a non-vaccinated person is the same as the pre-exposure regimen. Imovax may interact with chemotherapy or radiation cancer treatments, cyclosporine, sirolimus, tacrolimus, basiliximab, efalizumab, muromonab-CD3, mycophenolate mofetil, azathioprine, leflunomide, etanercept, or steroids. Tell your doctor all medications and supplements you are taking. Imovax should be given during pregnancy only if prescribed. It is not known whether this vaccine is harmful to a fetus. It is not known whether Imovax rabies vaccine passes into breast milk or if it could harm a nursing baby. Consult your doctor before breast-feeding.
Our Imovax Rabies Vaccine 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.
Imovax in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
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 shot caused any side effects.
Becoming infected with rabies is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.
Call your doctor at once if you have a serious side effect such as:
- a very high fever, (above 104 degrees);
- weakness or prickly feeling in your fingers or toes; or
- problems with balance or eye movement, trouble speaking or swallowing.
Less serious side effects may include:
- pain, swelling, itching, or redness where the shot was given;
- muscle pain; or
- nausea, stomach pain.
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 Imovax (Rabies Vaccine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Imovax FDA Prescribing Information: Side Effects
- Once initiated, rabies prophylaxis should not be interrupted or discontinued because of local or mild systemic adverse reactions to rabies vaccine. Usually such reactions can be successfully managed with anti-inflammatory, antihistaminic, and antipyretic agents.11
- Reactions after vaccination with HDCV have been observed.13 In a study using five doses of HDCV, local reactions such as pain, erythema, swelling or itching at the injection site were reported in about 25% of recipients of HDCV, and mild systemic reactions such as headache, nausea, abdominal pain, muscle aches, and dizziness were reported in about 20% of recipients.8
- Serious systemic anaphylactic or neuroparalytic reactions occurring during the administration of rabies vaccines pose a dilemma for the attending physician. A patient's risk of developing rabies must be carefully considered before deciding to discontinue vaccination. Moreover, the use of corticosteroids to treat life-threatening neuroparalytic reactions carries the risk of inhibiting the development of active immunity to rabies. It is especially important in these cases that the serum of the patient be tested for rabies antibodies. Advice and assistance on the management of serious adverse reactions in persons receiving rabies vaccines may be sought from the local or state health department.8
- SEE WARNINGS AND CONTRAINDICATIONS SECTIONS FOR ADDITIONAL STATEMENTS.
Data from post-marketing experience
The following additional adverse events have been identified during postapproval use of Imovax Rabies vaccine. 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 Imovax Rabies vaccine exposure.
Blood and Lymphatic System Disorders
Immune System Disorders
Nervous System Disorders
Musculoskeletal and Connective Tissue Disorders
General Disorders and Administration Site Conditions
Respiratory, Thoracic, and Mediastinal Disorders
Read the entire FDA prescribing information for Imovax (Rabies Vaccine)
Additional Imovax 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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