Rabavert

Last updated on RxList: 7/27/2021
Rabavert Side Effects Center

What Is Rabavert?

RabAvert (rabies vaccine) is used to prevent rabies in people who have been exposed to the rabies virus.

What Are Side Effects of Rabavert?

Common side effects of RabAvert include injection site reactions (pain, swelling, itching, and redness), headache, increased heart rate, hot flashes, joint or muscle pain, nausea, body aches, flu symptoms, swollen glands, general ill feeling (malaise), tiredness, and dizziness.

Dosage for Rabavert

The recommended dose of RabAvert is 1 mL.

What Drugs, Substances, or Supplements Interact with Rabavert?

Cancer treatments, Neoral, Rapamune, Orthoclone, CellCept, Enbrel, steroid medications, Flovent, and Nasonex may interact with RabAvert. Tell your doctor all medications you take.

Rabavert During Pregnancy and Breastfeeding

Before taking RabAvert tell your doctor if you have a severe illness with a fever or if you are pregnant or breastfeeding.

Additional Information

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.

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Rabavert Consumer Information

Get emergency medical help if you have 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 rare but serious side effects, such as:

  • a very high fever;
  • tingling or a prickly feeling in your fingers or toes;
  • weakness or unusual feeling in your arms and legs; or
  • problems with balance or eye movement, trouble speaking or swallowing.

Common side effects may include:

  • pain, redness, or a hard lump where the shot was given;
  • fever, flu symptoms, swollen glands, weakness, general ill feeling;
  • headache, feeling tired;
  • dizziness;
  • muscle or joint pain;
  • nausea; or
  • skin rash.

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)

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Rabavert Professional Information

SIDE EFFECTS

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

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 CONTRAINDICATIONS).

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 with an 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 group receiving RabAvert. Localized lymphadenopathy was reported in about 15% of each group. The most common systemic reactions were malaise (15% RabAvert vs. 25% HDCV), headache (10% RabAvert vs. 20% HDCV), and dizziness (15% RabAvert vs. 10% HDCV). In a recent study in the US5, 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 group receiving RabAvert. The most common systemic reactions were headache (52% RabAvert vs. 45% HDCV), myalgia (53% RabAvert vs. 38% HDCV), and malaise (20% RabAvert vs. 17% HDCV). 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 1 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.

Central Nervous System

Neuroparalysis, encephalitis, meningitis, transient paralysis, Guillain-Barré 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 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 healthcare 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 1-800-822-7967.1 In the US, such events can be reported to GlaxoSmithKline: phone: 1-888-825-5249.

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

© Rabavert Patient Information is supplied by Cerner Multum, Inc. and Rabavert Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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