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Botulism antitoxin Side Effects

For the Consumer

Applies to botulism antitoxin: intravenous solution

Along with its needed effects, botulism antitoxin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking botulism antitoxin:

More common
  • Headache
  • hives or welts
  • itching skin
  • nausea
  • rash
  • redness of the skin
Less common
  • Chills
  • fever
  • throat discomfort
Rare
  • Chest pain or discomfort
  • cough
  • difficulty with breathing
  • fast, pounding, or irregular heartbeat or pulse
  • feeling of discomfort
  • increased sweating
  • inflammation of the joints
  • lightheadedness, dizziness, or fainting
  • muscle aches
  • no blood pressure or pulse
  • noisy breathing
  • slow or irregular heartbeat
  • stopping of heart
  • swollen lymph glands
  • tightness in the chest
  • unconsciousness
  • unusual tiredness
Incidence not known
  • Blurred vision
  • confusion
  • difficulty with moving
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • hoarseness
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle cramping
  • muscle pains or stiffness
  • noisy breathing
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness of the skin
  • sweating
  • swollen joints
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin

Some side effects of botulism antitoxin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare
  • Anxiety
  • decrease in the frequency of urination
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • dry mouth
  • hyperventilation
  • irritability
  • painful urination
  • restlessness
  • shaking
  • trouble sleeping
Incidence not known
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For Healthcare Professionals

Applies to botulism antitoxin: injectable solution

Hypersensitivity

During 1967 to 1977, when larger antitoxin doses were given, hypersensitivity reactions were reported in 9% of patients and anaphylaxis occurred in 2% of patients. within 10 minutes of antitoxin administration.

An investigational heptavalent antitoxin (n=50) was associated with serum sickness (2%) and mild allergic reactions (18%).[Ref]

Hypersensitivity reactions have included urticaria, serum sickness and anaphylaxis. A small challenge dose should be administered before the full dose to screen patients for hypersensitivity.[Ref]

References

1. "Product Information. Botulism Antitoxin Bivalent (Equine) Types A and B (botulism antitoxin bivalent (Equine) A and B)." Aventis Pharmaceuticals, Swiftwater, PA.

Some side effects of botulism antitoxin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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