Prescription medicine
Sodium nitroprusside Brand names: Nipride
Sodium nitroprusside (Nipride) is a prescription medicine with an FDA approval on record since 1974. FDA's NDC Directory lists it from 12 generic labelers.
- Generic listed
- Boxed warning
Check it at the source: the sodium nitroprusside FDA label on DailyMed (effective August 10, 2026, Micro Labs Limited); the NDA 17546 record on Drugs@FDA; every sodium nitroprusside label on DailyMed.
Highlights of the record
FDA label of August 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Sodium nitroprusside injection is not suitable for direct injection. The solution must be further diluted in sterile 5% dextrose injection before infusion. Sodium nitroprusside can cause precipitous decreases in blood pressure (see DOSAGE AND ADMINISTRATION ). In patients not properly monitored, these decreases can lead to irreversible is chemic injuries or death. Sodium nitroprusside should be used only when available equipment and personnel allow blood pressure to be continuously monitored. Except when used briefly or at low (< 2 mcg/kg/min) infusion rates, sodium nitroprusside gives rise to important quantities of cyanide ion, which can reach toxic, potentially lethal levels (see WARNINGS ). The usual dose rate is 0.5 to 10 mcg/kg/min, but infusion at the maximum dose rate should never last more than 10 minutes. If blood pressure has not been adequately controlled after 10 minutes of infusion at the maximum rate, administration of sodium nitroprusside should be terminated immediately. Although acid-base balance and venous oxygen concentration should be monitored and may indicate cyanide toxicity, these laboratory tests provide imperfect guidance.
Used for
From the label: indications and usageSodium nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises.
Forms and strengths
- 0.2 mg/ml
- 0.5 mg/ml
- 25 mg/ml
- 50 mg/2ml
Injection; injection (solution); injection (solution) (concentrate).
On the market
- Earliest approval on file
- May 10, 1974 Nipride, Roche; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 24 first June 9, 1986; 11 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 13 of which 12 under generic applications, 1 under brand applications, repackagers included
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
- 382 through July 30, 2026
What is sodium nitroprusside used for?
From the label: indications and usageSodium nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside injection is also indicated for the treatment of acute congestive heart failure.
Conditions named in the indications of sodium nitroprusside's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Vasodilator.
Source: FDA drug label (SODIUM NITROPRUSSIDE), Micro Labs Limited, effective August 10, 2026 (SPL set 5a599880-c133-44ef-a9f2-bd1b681563be), via openFDA; the full label on DailyMed
Is there a generic for sodium nitroprusside (Nipride)?
The FDA approved the first generic sodium nitroprusside on June 9, 1986. 24 generic applications are approved; 11 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists sodium nitroprusside from 12 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1974 earliest approval on file
- 1986 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the sodium nitroprusside label say about other medicines?
The sodium nitroprusside label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name sodium nitroprusside. 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 |
|---|---|---|
| Methylene blue | warnings and precautions | When methemoglobinemia is diagnosed, the treatment of choice is 1-2 mg/kg of methylene blue, administered intravenously over several minutes. |
| Riociguat | contraindications | Acute heart failure associated with reduced peripheral vascular resistance. Concomitant use with sildenafil, tadalafil, vardenifil, or riociguat. |
| Sildenafil | contraindications | Acute heart failure associated with reduced peripheral vascular resistance. Concomitant use with sildenafil, tadalafil, vardenifil, or riociguat. |
| Sodium thiosulfate | warnings | Cyanide Toxicity: As described in CLINICAL PHARMACOLOGY above, sodium nitroprusside infusions at rates above 2 mcg/kg/min generate cyanide ion (CN¯) faster than the body can normally dispose of it. … |
| Tadalafil | contraindications | Acute heart failure associated with reduced peripheral vascular resistance. Concomitant use with sildenafil, tadalafil, vardenifil, or riociguat. |
Other labels that name sodium nitroprusside
Source: FDA drug label (SODIUM NITROPRUSSIDE), Micro Labs Limited, effective August 10, 2026 (SPL set 5a599880-c133-44ef-a9f2-bd1b681563be), via openFDA; the full label on DailyMed
What do FAERS reports show for sodium nitroprusside?
The FDA Adverse Event Reporting System holds 382 reports that list sodium nitroprusside among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 84 are coded as a death and 173 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 else is labeled for the same conditions as sodium nitroprusside?
3 other medicines are given the same way (intravenous) and in the same FDA class as sodium nitroprusside or labeled mainly for the same use (heart failure), the same class first. Heart failure lists all 37 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Milrinone | Heart failure | 13 labelers | n/a | No current entry |
| Furosemide | Heart failure | 13 labelers | $0.490 per mL 20 mg/2 mL vial | In shortage |
| Chlorothiazide | Heart failure | 5 labelers | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as sodium nitroprusside
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to sodium nitroprusside
- 3 medicines for the same use
- Other vasodilators
- the pharmacologic class, with prices and generics
- Sodium nitroprusside side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other