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Rabavert

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Rabavert

Rabavert Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

RabAvert (rabies vaccine) is used to prevent rabies in people who have been exposed to the rabies virus. Common side effects of RabAvert include pain, swelling, and redness at the injection site, headache, increased heart rate, hot flashes, muscle pain, and nausea.

The recommended dose of RabAvert is 1 mL. Cancer treatments, Neoral, Rapamune, Orthoclone, CellCept, Enbrel, steroid medications, Flovent, and Nasonex may interact with RabAvert. Tell your doctor all medications you take. Before taking RabAvert tell your doctor if you have a severe illness with a fever or if you are pregnant or breastfeeding.

Our RabAvert (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.

Rabavert in Detail - Patient Information: Side Effects

Keep track of any and all side effects you have after receiving this vaccine. When you receive another vaccine in the future, you will need to tell the doctor if the first shot caused any side effects. Getting rabies disease is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects. 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:

  • fever, chills, weakness, body aches, flu symptoms;
  • severe headache, problems with your vision;
  • numbness or tingly feeling;
  • swollen lymph glands; or
  • skin rash.

Less serious side effects may include:

  • pain, swelling, itching, or redness where the shot was given;
  • headache;
  • increased heart rate;
  • hot flashes;
  • 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 Rabavert (Rabies Vaccine) »

What is Prescribing information?

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

Rabavert FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

SEE ALSO WARNINGS AND CONTRAINDICATIONS SECTIONS FOR ADDITIONAL STATEMENTS

Local reactions such as induration, swelling and reddening have been reported more often than systemic reactions. In a comparative trial in normal volunteers, Dreesen et al. (3, 24) described their experience with RabAvert (rabies vaccine) compared to a HDCV rabies vaccine. Nineteen subjects received RabAvert (rabies vaccine) and 20 received HDCV. The most commonly reported adverse reaction was pain at the injection site, reported in 45% of the HDCV group, and 34% of the RabAvert (rabies vaccine) group. Localized lymphadenopathy was reported in about 15% of each group. The most common systemic reactions were malaise (15 % RabAvert (rabies vaccine) group vs. 25 % HDCV group), headache (10 % RabAvert (rabies vaccine) group vs. 20 % HDCV group), and dizziness (15 % RabAvert (rabies vaccine) group vs. 10 % HDCV group). In a recent study in the USA (4), 83 subjects received RabAvert (rabies vaccine) and 82 received HDCV. Again, the most common adverse reaction was pain at the injection site in 80% in the HDCV group and 84% in the RabAvert (rabies vaccine) group. The most common systemic reactions were headache (52% RabAvert (rabies vaccine) group vs. 45% HDCV group), myalgia (53% RabAvert (rabies vaccine) group vs. 38% HDCV group) and malaise (20% RabAvert (rabies vaccine) group vs. 17% HDCV group). None of the adverse events was serious, almost all adverse events were of mild or moderate intensity. Statistically significant differences between vaccination groups were not found. Both vaccines were generally well tolerated.

Uncommonly observed adverse events include temperatures above 38°C (100°F), swollen lymph nodes, and gastrointestinal complaints. In rare cases, patients have experienced severe headache, fatigue, circulatory reactions, sweating, chills, monoarthritis and allergic reactions; transient paresthesias and one case of suspected urticaria pigmentosa have also been reported.

Type III hypersensitivity reactions in pre-exposure booster immunizations have been reported with one HDCV rabies vaccine (25 - 27). These reactions are thought to be due to small amounts of human serum albumin (HSA) rendered allergenic by beta-propiolactone (23, 28, 29). Human serum albumin (HSA) is present in RabAvert (rabies vaccine) at concentrations less than 0.3 μg/dose. No type III hypersensitivity reactions have been observed with RabAvert (rabies vaccine) (30).

Serious systemic anaphylactic reactions or neuroparalytic events have been reported in association with RabAvert (rabies vaccine) administration. Against a background of 11.8 million doses distributed world-wide 10 cases of encephalitis (1 death) or meningitis, 7 cases of transient paralysis including 2 cases of Guillain-Barré Syndrome, 1 case of myelitis, 1 case of retrobulbar neuritis, and 2 cases of suspected multiple sclerosis have been temporally associated with the use of RabAvert (rabies vaccine) . Also, 2 cases of anaphylactic shock have been reported. A patient's risk of developing rabies must be carefully considered, however, before deciding to discontinue immunization (see WARNINGS).

The use of corticosteroids to treat life-threatening neuroparalytic reactions may inhibit the development of immunity to rabies (see PRECAUTIONS: DRUG INTERACTIONS).

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 and antipyretic agents.

Reporting of Adverse Events

Adverse events should be reported by the health care provider or patient to the US Department of Health and Human Services (DHHS) Vaccine Adverse Event Reporting System (VAERS). Report forms and information about reporting requirements or completion of the form can be obtained from VAERS by calling the toll-free number 1-800-822-7967 (26). In the USA, such events can be reported to the Professional Services Department, Chiron Corporation: phone: 1-888-CHIRON-7.

Read the entire FDA prescribing information for Rabavert (Rabies Vaccine) »

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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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