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Sodium nitrite Side Effects

For the Consumer

Applies to sodium nitrite: intravenous solution

What are some side effects that I need to call my doctor about right away?

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 methemoglobinemia like a blue or gray color of the lips, nails, or skin; a heartbeat that does not feel normal; seizures; very bad dizziness or passing out; very bad headache; feeling very sleepy; feeling tired or weak; or shortness of breath. This effect is rare but may be deadly if it happens.
  • Very bad dizziness or passing out.
  • A fast heartbeat.
  • Feeling confused.
  • Blurred eyesight.
  • Numbness and tingling.

What are some other side effects of this drug?

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:

  • Dizziness.
  • Flushing.
  • Headache.
  • Upset stomach or throwing up.
  • Bad taste in your mouth.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to sodium nitrite: compounding powder, intravenous solution

Cardiovascular

Frequency not reported: Hypotension, tachycardia, palpitations, dysrhythmia, severe hypotension, cyanosis, vasodilation resulting in syncope[Ref]

Dermatologic

Frequency not reported: Urticaria, diaphoresis[Ref]

Gastrointestinal

Frequency not reported: Nausea, vomiting, abdominal pain[Ref]

Hematologic

Frequency not reported: Methemoglobinemia[Ref]

Local

Frequency not reported: Injection site tingling[Ref]

Metabolic

Frequency not reported: Acidosis[Ref]

Nervous system

Frequency not reported: Syncope, headache, dizziness, seizures, confusion, coma, lightheadedness, generalized numbness and tingling[Ref]

Psychiatric

Frequency not reported: Anxiety[Ref]

Respiratory

Frequency not reported: Tachypnea, dyspnea[Ref]

Other

Frequency not reported: Fatigue, weakness, death[Ref]

Ocular

Frequency not reported: Blurred vision[Ref]

References

1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. "Product Information. Sodium Nitrite (sodium nitrite)." Hope Pharmaceuticals, Scottsdale, AZ.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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