Skip to content

Ziconotide

Published: July 26, 2026Updated: July 26, 2026

Ziconotide is a non-opioid analgesic used to treat severe chronic pain in patients who require intrathecal (spinal) therapy and have not responded to other treatments. It is a synthetic peptide derived from cone snail venom that works by blocking calcium channels on pain-sensing nerves in the spinal cord, reducing the transmission of pain signals.

Quick summary

Ziconotide is an intrathecal non-opioid pain medication that blocks N-type calcium channels to manage severe chronic pain when other treatments have failed.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy
BOXED WARNING

This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.

Key facts at a glance

ATC
N02BG08
RxNorm
68503
Generic
Ziconotide
Class
atc-n02
Brands
Prialt
Availability
rx
Lactation
unknown
Routes
—
Forms
injection
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
500mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (standard)tablet
Usual dose
250mg twice daily
Maximum
consult physician
Frequency
every 12 hours
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
400mg daily
Maximum
consult physician
Frequency
once daily
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Doses significantly above therapeutic range (typically >10 mcg/day) may cause serious neurological and psychiatric toxicity
Chronic overdose: Prolonged exposure to doses above recommended therapeutic range may lead to cumulative CNS effects including severe cognitive impairment and neurological dysfunction
Immediate actions
Discontinue intrathecal infusion immediately, supportive care, monitoring of respiratory and cardiac function, consider intrathecal catheter removal if appropriate
Antidote
No specific antidote exists(Treatment is supportive and symptomatic; no antidote has demonstrated proven effectiveness for ziconotide overdose)
Poison Control: 1-800-222-1222

Special Populations

9 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if potential benefits justify potential risks to fetus; avoid in pregnancy unless absolutely necessary

Monitor

regular fetal monitoring and ultrasound assessments

Use with caution and monitor for adverse effects.

⚠

pregnancy

second trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if potential benefits justify potential risks to fetus

Monitor

regular fetal monitoring

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

avoid if possible

Key Recommendations

use only if potential benefits justify potential risks; consider timing of delivery

Monitor

regular fetal monitoring and assessment of fetal wellbeing

Use with caution and monitor for adverse effects.

?

lactation

breastfeeding
unknown
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

breastfeeding not recommended during ziconotide therapy; either discontinue drug or discontinue breastfeeding

Monitor

monitor infant for adverse effects

⚠

geriatric

elderly over 65
caution
FDA Category
N
Dose Adjustment

start at lower end of dosing range

Key Recommendations

use with caution; increased sensitivity to CNS effects; start with lowest effective dose and titrate slowly

Monitor

closely monitor for cognitive effects, confusion, and sedation

Use with caution and monitor for adverse effects.

✗

pediatric_age

children under 18
unsafe
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

not recommended for use in pediatric patients; safety and efficacy not established in patients under 18 years

Monitor

not applicable

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

renal_impairment

severe renal impairment
caution
FDA Category
N
Dose Adjustment

no specific dose adjustment required

Key Recommendations

use with caution; drug is primarily cleared by proteolytic cleavage not renal excretion; however monitor closely for adverse effects

Monitor

monitor renal function and watch for accumulation of adverse effects

Use with caution and monitor for adverse effects.

⚠

hepatic_impairment

moderate hepatic impairment
caution
FDA Category
N
Dose Adjustment

no specific dose adjustment required

Key Recommendations

use with caution; limited data in hepatic impairment; monitor closely for adverse effects

Monitor

monitor liver function tests and for signs of toxicity

Use with caution and monitor for adverse effects.

✗

alcohol_users

active alcohol use
unsafe
FDA Category
N
Dose Adjustment

avoid concomitant use

Key Recommendations

avoid alcohol consumption during ziconotide therapy; alcohol may enhance CNS depressant effects

Monitor

monitor for increased sedation, respiratory depression, and cognitive impairment

Use of this medication in this population requires careful consideration of risks and benefits.

Statistics and clinical data

prescribingFDA
2023

FDA approval year

Value:2004

FDA approval for chronic severe pain management

drug_classFDA
2023

Drug class

Value:N-type calcium channel blocker

Pharmacological classification

administrationFDA
2023

Route of administration

Value:Intrathecal injection

Method of delivery into cerebrospinal fluid

mechanismFDA
2023

Mechanism of action

Value:Blocks N-type calcium channels in spinal cord

Primary pharmacodynamic action

Severe chronic pain requiring intrathecal therapy, particularly when patients have not responded to or cannot tolerate other analgesics including systemic opioids.

Binds selectively to N-type voltage-sensitive calcium channels located on primary nociceptive (A-δ and C) afferent nerve fibers in the superficial layers (Rexed laminae I and II) of the dorsal horn in the spinal cord, blocking calcium influx and inhibiting neurotransmitter release to reduce pain signal transmission.

Administered via intrathecal injection directly into the cerebrospinal fluid. Requires careful dose titration due to narrow therapeutic window. Common adverse effects include dizziness, confusion, and hallucinations. Not an opioid and does not produce physical dependence, but psychiatric symptoms may occur requiring close monitoring.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

WellAlly may earn a referral fee from linked resources at no extra cost to you. Editorial content is never influenced by commercial relationships.

This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy