Prescription medicine
Sodium nitrite
Sodium nitrite is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the sodium nitrite FDA label on DailyMed (effective October 6, 2025, Hope Pharmaceuticals); the NDA 203922 record on Drugs@FDA; every sodium nitrite label on DailyMed.
Highlights of the record
FDA label of October 6, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
LIFE THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION.
Sodium nitrite can cause serious adverse reactions and death in humans, even at doses less than twice the recommended therapeutic dose. Sodium nitrite causes hypotension and methemoglobin formation, which diminishes oxygen carrying capacity. Hypotension and methemoglobin formation can occur concurrently or separately. Because of these risks, sodium nitrite should be used to treat acute life-threatening cyanide poisoning and be used with caution in patients where the diagnosis of cyanide poisoning is uncertain. Patients should be closely monitored to ensure adequate perfusion and oxygenation during treatment with sodium nitrite. Alternative therapeutic approaches should be considered in patients known to have diminished oxygen or cardiovascular reserve (e.g., smoke inhalation victims, pre-existing anemia, cardiac or respiratory compromise), and those at higher risk of developing methemoglobinemia (e.g., congenital methemoglobin reductase deficiency) as they are at greater risk for potentially life-threatening adverse events related to the use of sodium nitrite. [see Warnings and Precautions (5.1 and 5.2) ] WARNING: LIFE-THREATENING HYPOTENSION AND METHEMOGLOBIN FORMATION See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageSodium 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.
Forms and strengths
- 30 mg/ml
Injection (solution).
On the market
- Earliest approval on file
- February 14, 2012 Sodium Nitrite, Hope Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 24, 2031 Sodium Nitrite injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 56 through July 30, 2026
What is sodium nitrite used for?
From the label: indications and usageSodium 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. Sodium Nitrite Injection, an antidote, is indicated for sequential use with sodium thiosulfate for treatment of acute cyanide poisoning that is judged to be serious or life-threatening. ( 1 ) Use with caution if the diagnosis of cyanide poisoning is uncertain.
Source: FDA drug label (Sodium Nitrite), Hope Pharmaceuticals, effective October 6, 2025 (SPL set 52f01c6e-172a-47a9-98a6-9eab7651a032), via openFDA; the full label on DailyMed
Is there a generic for sodium nitrite?
No generic sodium nitrite is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Sodium Nitrite injection: the compound patent runs to December 24, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sodium nitrite label say about other medicines?
The sodium nitrite label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Nitric oxide | warnings and precautions | Use sodium nitrite with caution in the presence of concomitant antihypertensive medications, diuretics or volume depletion due to diuretics, or drugs known to increase vascular nitric oxide, such as PDE5 inhibitors. |
Source: FDA drug label (Sodium Nitrite), Hope Pharmaceuticals, effective October 6, 2025 (SPL set 52f01c6e-172a-47a9-98a6-9eab7651a032), via openFDA; the full label on DailyMed
What do FAERS reports show for sodium nitrite?
The FDA Adverse Event Reporting System holds 56 reports that list sodium nitrite among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 38 are coded as a death and 23 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Sodium nitrite side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other