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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

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;
  • body aches, flu symptoms, swollen glands, general ill feeling;
  • headache, feeling tired;
  • dizziness;
  • joint or muscle pain; or
  • nausea.

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

In very rare cases, neurological and neuroparalytical events have been reported in temporal association with administration of RabAvert (see also WARNINGS section). These include cases of hypersensitivity (see CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS sections).

The most commonly occurring adverse reactions are injection site reactions, such as injection site erythema, induration and pain; flu-like symptoms, such as asthenia, fatigue, fever, headache, myalgia and malaise; arthralgia, dizziness, lymphadenopathy, nausea, and rash.

A patient's risk of acquiring rabies must be carefully considered before deciding to discontinue vaccination. Advice and assistance on the management of serious adverse reactions for persons receiving rabies vaccines may be sought from the state health department or CDC (see also CONTRAINDICATIONS section).

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.4 described their experience with RabAvert compared to a HDCV rabies vaccine. Nineteen subjects received RabAvert 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 group. Localized lymphadenopathy was reported in about 15% of each group. The most common systemic reactions were malaise (15 % RabAvert group vs. 25 % HDCV group), headache (10 % RabAvert group vs. 20 % HDCV group), and dizziness (15 % RabAvert group vs. 10 % HDCV group). In a recent study in the USA5, 83 subjects received RabAvert 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 group. The most common systemic reactions were headache (52% RabAvert group vs. 45% HDCV group), myalgia (53% RabAvert group vs. 38% HDCV group) and malaise (20% RabAvert group vs. 17% HDCV group). None of the adverse events were 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, pain in limbs 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.

Observed During Clinical Practice

(See WARNINGS AND PRECAUTIONS)

The following adverse reactions have been identified during post approval use of RabAvert. Because these reactions are reported voluntarily from a population of uncertain size, estimates of frequency cannot be made. These events have been chosen for inclusion due to their seriousness, frequency of reporting, causal connection to RabAvert, or a combination of these factors:

Allergic: Anaphylaxis, Type III hypersensitivity-like reactions, bronchospasm, urticaria, pruritis, edema

CNS: Neuroparalysis, encephalitis, meningitis, transient paralysis, Guillain-Barre Syndrome, myelitis, retrobulbar neuritis, multiple sclerosis, vertigo, visual disturbance

Cardiac: Palpitations, hot flush

Local: Extensive limb swelling

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 1-800-822-79671. In the USA, such events can be reported to the Professional Services department, Novartis Vaccines and Diagnostics, Inc.: phone: 1-800-244-7668.

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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