Pralidoxime Side Effects

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

For the Consumer

Applies to pralidoxime: intravenous powder for injection

Some of the side effects of pralidoxime may be similar to the symptoms of poisoning. Your caregivers will watch you closely to determine whether your body is responding well to the medication, or if you are having any serious side effects.

Get emergency medical help if you have any of these signs of an allergic reaction while taking pralidoxime: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have a serious side effect such as:

• fast heart rate;

• rapid breathing;

• increased muscle stiffness;

• a choking feeling;

Less serious side effects of pralidoxime may include:

• pain where the medicine was injected;

• blurred vision;

• feeling dizzy or drowsy;

• headache; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to pralidoxime: intravenous powder for injection

General

Pralidoxime has been well tolerated in most cases; however, it should be considered that the desperate condition of the organophosphate-poisoned patient generally masks the minor signs and symptoms noted in normal subjects who have not been exposed to anticholinesterase poisons. Many of the signs and symptoms of organophosphate poisoning are similar to the side effects of pralidoxime. It may be difficult to ascertain which effects are due to the drug and which are toxic symptoms produced by atropine or the organophosphate compounds.

Cardiovascular

Cardiovascular side effects have included tachycardia and increased systolic and diastolic blood pressure in normal subjects. Tachycardia has also occurred after excessively rapid infusions. Asystole and cardiac arrest have been reported; however, causality is unclear due to the presence of atropine and an organophosphate insecticide.

Musculoskeletal

Musculoskeletal side effects have included muscle weakness in normal subjects. Laryngospasm and muscle rigidity have occurred after excessively rapid infusions.

Nervous system

Nervous system side effects have included dizziness, headache, and drowsiness in normal subjects.

Respiratory

Respiratory side effects have included hyperventilation in normal subjects.

Ocular

Ocular side effects have included blurred vision, diplopia, and impaired accommodation in normal subjects.

Gastrointestinal

Gastrointestinal side effects have included nausea in normal subjects.

Metabolic

Metabolic side effects have included transient elevations of creatine phosphokinase in all normal subjects.

Hepatic

Hepatic side effects have included elevations of AST and/or ALT in normal subjects.

Elevated AST and/or ALT were reported in 1 of 6 normal subjects given 1200 mg intramuscularly and 4 of 6 normal subjects given 1800 mg intramuscularly. Levels returned to normal in about 2 weeks.

Local

Local side effects have included mild to moderate injection site pain, 40 to 60 minutes after intramuscular injection.

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