Applies to rabies vaccine, purified chick embryo cell: intramuscular injectable, intramuscular suspension reconstituted.

Serious side effects

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of meningitis like headache with fever, stiff neck, upset stomach, confusion, or if lights bother the eyes.
• Feeling very tired or weak.
• Not able to move face muscles as much.
• Muscle weakness.
• Not able to move.
• Change in eyesight.
• Swollen gland.
• Very bad dizziness or passing out.
• A burning, numbness, or tingling feeling that is not normal.
• Trouble controlling body movements.

Other side effects

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Pain, redness, or swelling where the shot was given.
• Flu-like signs. These include headache, weakness, fever, shakes, aches, pains, and sweating.
• Upset stomach.
• Muscle or joint pain.
• Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to rabies vaccine, purified chick embryo cell: intramuscular powder for injection.

Hypersensitivity

Rare (less than 0.1%): Allergic reactions

Postmarketing reports: Anaphylaxis, type II hypersensitivity-like reactions^[Ref]

Nervous system

Very common (10% or more): Headache (52%), dizziness (15%)

Frequency not reported: Transient paresthesias

Postmarketing reports: Neuroparalysis, encephalitis, meningitis, transient paralysis, Guillain-Barre Syndrome, myelitis, retrobulbar neuritis, multiple sclerosis, presyncope, syncope, vertigo, visual disturbance^[Ref]

Local

Very common (10% or more): Pain at the injection site (84%)

Postmarketing reports: Extensive limb swelling^[Ref]

Dermatologic

Rare (less than 0.1%): Sweating

Frequency not reported: Urticaria pigmentosa

Postmarketing reports: Urticaria, pruritus, angioedema^[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (53%)

Uncommon (0.1% to 1%): Pain in limbs

Rare (less than 0.1%): Chills, monoarthritis^[Ref]

Other

Very common (10% or more): Malaise (15%)

Uncommon (0.1% to 1%): Temperature above 38C (100F)

Rare (less than 0.1%): Fatigue, circulatory reactions

Postmarketing reports: Edema^[Ref]

Hematologic

Very common (10% or more): Lymphadenopathy (15%)

Uncommon (0.1% to 1%): Swollen lymph nodes^[Ref]

Respiratory

Postmarketing reports: Bronchospasm^[Ref]

Cardiovascular

Postmarketing reports: Palpitations, hot flash^[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Gastrointestinal complaints^[Ref]