Prescription medicine
Ziconotide Brand names: Prialt
Ziconotide (Prialt) is a prescription medicine with an FDA approval on record since 2004. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ziconotide FDA label on DailyMed (effective May 31, 2025, TerSera Therapeutics LLC); the NDA 21060 record on Drugs@FDA; every ziconotide label on DailyMed.
Highlights of the record
FDA label of May 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
NEUROPSYCHIATRIC ADVERSE REACTIONS.
PRIALT is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue PRIALT therapy in the event of serious neurological or psychiatric signs or symptoms. WARNING: NEUROPSYCHIATRIC ADVERSE REACTIONS See full prescribing information for complete boxed warning Severe psychiatric symptoms and neurological impairment may occur during treatment with PRIALT. Do not treat patients with a pre-existing history of psychosis with PRIALT
Used for
From the label: indications and usagePRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.
Forms and strengths
- 20ml
- 5ml
Injection (solution).
On the market
- Earliest approval on file
- December 28, 2004 Prialt, Esteve; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 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
- 2,432 through July 30, 2026
What is ziconotide used for?
From the label: indications and usagePRIALT (ziconotide) solution, intrathecal infusion is indicated for the management of severe chronic pain in adult patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine. PRIALT (ziconotide) solution, intrathecal infusion is an N-type calcium channel antagonist indicated for the management of severe chronic pain in patients for whom intrathecal therapy is warranted, and who are intolerant of or refractory to other treatment, such as systemic analgesics, adjunctive therapies, or intrathecal morphine.
Conditions named in the indications of ziconotide's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: N-type Calcium Channel Antagonist.
Source: FDA drug label (PRIALT), NDA021060 (Esteve), as published by TerSera Therapeutics LLC, effective May 31, 2025 (SPL set b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1), via openFDA; the full label on DailyMed
Is there a generic for ziconotide (Prialt)?
No generic ziconotide is approved (Drugs@FDA, October 8, 2026).
- 2004 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for ziconotide?
The FDA Adverse Event Reporting System holds 2,432 reports that list ziconotide among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 118 are coded as a death and 560 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Ziconotide side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other