Sodium Nitrite

Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria.

• Sodium Nitrite Injection, an antidote, is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with Sodium Nitrite Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.

• None None.contraindicated

If clinical suspicion of cyanide poisoning is high, administer Sodium Nitrite Injection without delay and in conjunction with appropriate airway, ventilatory, and circulatory support. ( 2.1 ) The expert advice of a regional poison control center may be obtained by calling 1-800-222-1222. ( 2.1 ) Dosing : Age Intravenous Dose of Sodium Nitrite and Sodium Thiosulfate Adults 1.) Sodium Nitrite -10 mL of sodium nitrite at the rate of 2.5 to 5 mL/minute 2.) Sodium Thiosulfate - 50 mL of sodium thiosulfate immediately following administration of sodium nitrite. Children 1.) Sodium Nitrite - 0.2 mL/kg (6 mg/kg or 6-8 mL/m 2 BSA) of sodium nitrite at the rate of 2.5 to 5 mL/minute not to exceed 10 mL 2.) Sodium Thiosulfate - 1 mL/kg of body weight (250 mg/kg or approximately 30-40 mL/m 2 of BSA) not to exceed 50 mL total dose immediately following administration of sodium nitrite. Redosing : If signs of cyanide poisoning reappear, repeat treatment using one-half the original dose of both sodium nitrite and sodium thiosulfate. ( 2.2 ) Monitoring : Blood pressure must be monitored during treatment. ( 2.2 ) Sodium nitrite is chemically incompatible with hydroxocobalamin and should not be administered via the same intravenous line. ( 2.4 ) 2.1 Important Dosage and Administration Instructions If clinical suspicion of cyanide poisoning is high, administer Sodium Nitrite Injection without delay. Comprehensive treatment of acute cyanide intoxication requires support of vital functions.

Methemoglobinemia: Sodium nitrite reacts with hemoglobin to form methemoglobin and should be used with caution in patients known to have anemia. Monitor oxyhemoglobin and methemoglobin levels by pulse co-oximetry or other measurements. Optimally, the sodium nitrite dose should be reduced in proportion to the oxygen carrying capacity. ( 5.2 ) Smoke inhalation: Carbon monoxide contained in smoke can result in the formation of carboxyhemoglobin that can reduce the oxygen carrying capacity of the blood. Sodium nitrite should be used with caution in patients with smoke inhalation injury because of the potential for worsening hypoxia due to methemoglobin formation. Carboxyhemoglobin and oxyhemoglobin levels should be monitored by pulse oximetry or other measurements in patients that present with evidence of smoke inhalation. Optimally, the sodium nitrite dose should be reduced in proportion to the oxygen carrying capacity. ( 5.4 ) 5.1 Hypotension Sodium nitrite has been associated with severe hypotension, methemoglobinemia, and death at doses less than twice recommended therapeutic doses. Hypotension may occur concurrently or separately. Sodium nitrite should be used to treat life-threatening cyanide poisoning.

There have been no controlled clinical trials conducted to systematically assess the adverse events profile of sodium nitrite. The medical literature has reported the following adverse events in association with sodium nitrite administration. These adverse events were not reported in the context of controlled trials or with consistent monitoring and reporting methodologies for adverse events. Therefore, frequency of occurrence of these adverse events cannot be assessed. Cardiovascular system: syncope, hypotension, tachycardia, methemoglobinemia, palpitations, dysrhythmia Hematological: methemoglobinemia Central nervous system: headache, dizziness, blurred vision, seizures, confusion, coma Gastrointestinal system: nausea, vomiting, abdominal pain Respiratory system: tachypnea, dyspnea Body as a Whole : anxiety, diaphoresis, lightheadedness, injection site tingling, cyanosis, acidosis, fatigue, weakness, urticaria, generalized numbness and tingling Severe hypotension, methemoglobinemia, cardiac dysrhythmias, coma and death have been reported in patients without life-threatening cyanide poisoning but who were treated with injection of sodium nitrite at doses less than twice those recommended for the treatment of cyanide poisoning. Most common adverse reactions are: Syncope, hypotension, tachycardia, palpitations, dysrhythmia, methemoglobinemia, headache, dizziness, blurred vision, seizures, confusion, coma ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Hope Pharmaceuticals at 1-800-755-9595 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Lactation: Breastfeeding not recommended. ( 8.2 ) Renal impairment: Sodium nitrite is substantially excreted by the kidney. The risk of toxic reactions to this drug may be greater in patients with impaired renal function. ( 8.6 ). 8.1 Pregnancy Risk Summary Life-sustaining therapy should not be withheld. Cyanide poisoning is a medical emergency in pregnancy, which can be fatal for the pregnant woman and fetus if left untreated (see Clinical Considerations ). Therefore, if a pregnant woman has known or suspected cyanide poisoning, Sodium Nitrite Injection for sequential use with Sodium Thiosulfate Injection is recommended [see Indications and Usage (1) ]. There are no available data on Sodium Nitrite Injection use in pregnant women to establish a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. If available, consider alternative therapies not associated with methemoglobinemia. There are no intravenous animal studies to evaluate the effect of sodium nitrite on embryofetal development. In published animal studies, fetal mortality was reported when pregnant guinea pigs were subcutaneously administered sodium nitrite at 1.7 times the maximum recommended human dose (MRHD) of 450 mg sodium nitrite when maternal and fetal methemoglobin concentrations were at their peak.

Metabolism

Sodium Nitrite Sodium nitrite is a strong oxidant, and reacts rapidly with hemoglobin to form methemoglobin. The pharmacokinetics of free sodium nitrite in humans have not been well studied.

Large doses of sodium nitrite result in severe hypotension and toxic levels of methemoglobin which may lead to cardiovascular collapse. Sodium nitrite administration has been reported to cause or significantly contribute to mortality in adults at oral doses as low as 1 g and intravenous doses as low as 600 mg. A death attributed to sodium nitrite has been reported following administration of an adult dose (300 mg IV followed by a second dose of 150 mg) to a 17-month old child. Cyanosis may become apparent at a methemoglobin level of 10-20%. Other clinical signs and symptoms of sodium nitrite toxicity (anxiety, dyspnea, nausea, and tachycardia) can be apparent at methemoglobin levels as low as 15%. More serious signs and symptoms, including cardiac dysrhythmias, circulatory failure, and central nervous system depression are seen as methemoglobin levels increase, and levels above 70% are usually fatal. Treatment of overdose involves supplemental oxygen and supportive measures such as exchange transfusion.

• Jan 14, 2011NDANDA201444Hope Pharms
• Feb 14, 2012NDANDA203922Hope Pharms

1. 1Completed Suicide2546%
2. 2Methaemoglobinaemia1426%
3. 3Toxicity To Various Agents1324%
4. 4Overdose713%
5. 5Suicide Attempt713%
6. 6Cardiac Arrest611%
7. 7Cyanosis59.3%
8. 8Drug Ineffective59.3%
9. 9Anoxia47.4%
10. 10Brain Oedema47.4%
11. 11Hypoxia47.4%
12. 12Cardiac Failure Acute35.6%
13. 13Cardio-respiratory Arrest35.6%
14. 14Coma35.6%
15. 15Pulmonary Haemorrhage35.6%

Recent PubMed references pinned to Sodium Nitrite as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Sodium nitrite promotes atherosclerosis via IL-1β: Network toxicology and machine learning insights.
  PloS one · 2026 · Yang H, Yu Y, Zhang Y, et al.
  PMID 42085516DOI 10.1371/journal.pone.0347642
• NFIL3-dependent regulation of NF-κB pathway mediates alginic oligosaccharide alleviation of nitrite immunotoxicity in Procambarus clarkii.
  Fish & shellfish immunology · 2026 · Zhang X, Dai SG, Lu X, et al.
  PMID 41974290DOI 10.1016/j.fsi.2026.111328
• Features of metabolism and peculiarities of organs' structural reorganization by sodium nitrite with underlying tobacco intoxication.
  Wiadomosci lekarskie (Warsaw, Poland : 1960) · 2026 · Fedoniuk LY, Lykhatskyi PH, Fira LS, et al.
  PMID 41759011DOI 10.36740/WLek/217275
• Benefits of oral nitrite supplementation on mitochondrial respiration and physical function in older adults.
  The journals of gerontology. Series A, Biological sciences and medical sciences · 2026 · Forman DE, Perera S, Shiva S, et al.
  PMID 41691463DOI 10.1093/gerona/glag034
• Sodium nitrite impairs reproduction in female mice by disrupting ovarian steroid hormone synthesis and lipid metabolic pathways.
  Ecotoxicology and environmental safety · 2026 · Liu Y, Liu Y, Liu Y, et al.
  PMID 41601060DOI 10.1016/j.ecoenv.2025.119631
• Double Fatal Sodium Nitrite Poisoning-Double Homicide, Extended Suicide, or Suicide and Accident?
  International journal of molecular sciences · 2025 · Smędra A, Wochna K, Lisowski M, et al.
  PMID 41516096DOI 10.3390/ijms27010218
• Nitrite Dipstick Urinalysis as a Point-Of-Care Test for Sodium Nitrite Poisoning.
  Therapeutic drug monitoring · 2026 · Bethlehem C, Vleut IT, Augustijn D, et al.
  PMID 41508307DOI 10.1097/FTD.0000000000001430
• Chelesta-8,24-dien-3-ol in Ficus exasperata leaves enhances the prevention of sodium nitrite-induced hypoxia by binding to HIF-1 and NF-κB.
  Scientific reports · 2026 · Akinloye DI, Moses CA, Alum EU, et al.
  PMID 41501348DOI 10.1038/s41598-026-35307-w

The 10 most recently updated of 66 ClinicalTrials.gov registrations naming Sodium Nitrite as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Effect of Sublingually Generated S-nitroso-N-acetylcysteine on Systemic Blood Pressure.
  Completed · Early phase 1 · Interventional · 14 enrolled · University of Alabama at Birmingham
  NCT05798481updated 2025-11-26
• Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty
  Withdrawn · Phase 1 · Interventional · 0 enrolled · University of Alabama at Birmingham
  NCT05893160updated 2025-06-24
• Topical Sodium Nitrite in Sickle Cell Disease and Leg Ulcers
  Terminated · Phase 2 · Interventional · 18 enrolled · caterina P minniti
  NCT02863068updated 2025-05-07
• Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
  Suspended · Phase 3 · Interventional · 6,400 enrolled · University of Birmingham
  NCT04386070updated 2025-02-20
• Assessment of KM-001 - Safety, Tolerability, and Efficacy in Patients With PPPK1 or PC
  Completed · Phase 1 · Interventional · 18 enrolled · Orvida Pharma (formerly Kamari Pharma)
  NCT05956314updated 2025-01-15
• Study Designed to Evaluate Safety and Efficacy of 1% Topical Formulation of KM-001 on Type 1 Punctate Palmoplantar Keratoderma or Pachyonychia Congenita Diseases
  Completed · Phase 1 · Interventional · 14 enrolled · Orvida Pharma (formerly Kamari Pharma)
  NCT05435638updated 2025-01-07
• Nitrites, Skeletal Muscle Mitochondrial Bioenergetics, and Physical Activity in Old Age
  Completed · Phase 2 · Interventional · 64 enrolled · Gladwin, Mark, MD
  NCT04405180updated 2024-10-10
• Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis
  Terminated · Phase 1 · Phase 2 · Interventional · 4 enrolled · Schmidhofer, Mark, MD
  NCT02694393updated 2024-06-24
• Oral Nitrite in Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction
  Completed · Phase 2 · Interventional · 33 enrolled · University of Pittsburgh
  NCT03015402updated 2024-06-07
• PREvent Viral Exposure and Transmission Study: a COVID-19 (SARS-CoV-2) PEP Study (PREVENT)
  Withdrawn · Phase 2 · Phase 3 · Interventional · 0 enrolled · Thirty Respiratory Limited
  NCT04842331updated 2024-01-12

CPIC-curated drug–gene pairs for Sodium Nitrite. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• G6PDCPIC CFDA label: Actionable PGx
  G6PD

Frequently asked questions

How does Sodium Nitrite work?

Exposure to a high dose of cyanide can result in death within minutes due to the inhibition of cytochrome oxidase resulting in arrest of cellular respiration. Specifically, cyanide binds rapidly with cytochrome a3, a component of the cytochrome c oxidase complex in mitochondria.

What is Sodium Nitrite used for?

According to FDA labeling, Sodium Nitrite carries indications including: Sodium Nitrite Injection, an antidote, is indicated for sequential use with sodium thiosulfate for the treatment of acute cyanide poisoning that is judged to be serious or life-threatening. When the diagnosis of cyanide poisoning is uncertain, the potentially life-threatening risks associated with Sodium Nitrite Injection should be carefully weighed against the potential benefits, especially if the patient is not in extremis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Sodium Nitrite?

Sodium Nitrite is classified as Antidotes.

What are the contraindications for Sodium Nitrite?

Sodium Nitrite labeling lists contraindications including: None None.. Always consult the full prescribing information and a clinician.