Ziconotide side effects: what 2,432 FDA adverse event reports show
Drug class
N-type calcium channel antagonist
Label matched
Ziconotide Acetate (Prialt)
Who reports
2,432 reports · 48% serious · 118 with death outcome · 55% female
Used for
PRIALT (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.
What it is
PRIALT contains ziconotide, a synthetic equivalent of a naturally occurring conopeptide found in the piscivorous marine snail, Conus magus. Ziconotide is a 25 amino acid, polybasic peptide containing three disulfide bridges with a molecular weight of 2639 daltons and a molecular formula of C 102 H 172 N 36 O 32 S 7 .
Boxed warning
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.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 51 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hallucination, auditory | 133 | 72.7 61.5–85.8ROR 76.8 · χ² 9,255 / p <1e-300 | 71.3 EB05 61.7 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 56.0 | no trial data cached |
| Device issue | 313 | 31.0 28.0–34.4ROR 35.5 · χ² 9,074 / p <1e-300 | 30.9 EB05 28.1 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 57.1 | no trial data cached |
| Muscle spasticity | 35 | 24.4 17.6–33.9ROR 24.7 · χ² 760 / p 1e-167 | 24.1 EB05 18.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 26.4 | no trial data cached |
| Hallucination, visual | 53 | 21.8 16.7–28.5ROR 22.3 · χ² 1,031 / p 2e-226 | 21.6 EB05 17.2 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.9 | no trial data cached |
| Mental status changes | 66 | 20.5 16.2–26.0ROR 21.1 · χ² 1,205 / p 3e-264 | 20.4 EB05 16.6 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.8 | no trial data cached |
| Hallucination (hallucinations) | 168 | 19.4 16.7–22.4ROR 20.7 · χ² 2,912 / p <1e-300 | 19.3 EB05 17.0 · IC025 +3.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 21.0 | no trial data cached |
| Psychotic disorder | 65 | 19.0 15.0–24.2ROR 19.5 · χ² 1,090 / p 2e-239 | 18.9 EB05 15.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.9 | no trial data cached |
| Paranoia | 38 | 19.0 13.8–26.0ROR 19.2 · χ² 628 / p 8e-139 | 18.7 EB05 14.2 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.9 | no trial data cached |
| No therapeutic response | 20 | 14.0 9.0–21.6ROR 14.1 · χ² 228 / p 1e-51 | 13.3 EB05 8.6 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 18.8 | no trial data cached |
| Urinary retention | 53 | 13.7 10.5–17.9ROR 14.0 · χ² 614 / p 8e-136 | 13.5 EB05 10.7 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.1 · ♀ 30% (drug 55%) | no trial data cached |
| Delusion | 24 | 13.4 9.0–19.9ROR 13.5 · χ² 262 / p 3e-59 | 12.8 EB05 8.7 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 | no trial data cached |
| Withdrawal syndrome | 59 | 12.1 9.4–15.5ROR 12.3 · χ² 588 / p 3e-130 | 11.8 EB05 9.4 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 6.0 | no trial data cached |
| Aphasia (loss of speech) | 41 | 11.7 8.6–15.8ROR 11.9 · χ² 390 / p 4e-87 | 11.3 EB05 8.5 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 | no trial data cached |
| Confusional state (confusion) | 205 | 10.9 9.6–12.5ROR 11.8 · χ² 1,851 / p <1e-300 | 10.8 EB05 9.6 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 11.5 | no trial data cached |
| Sensory disturbance | 19 | 10.2 6.5–15.9ROR 10.2 · χ² 148 / p 2e-34 | 9.1 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Disorientation | 45 | 9.8 7.3–13.1ROR 9.9 · χ² 346 / p 1e-77 | 9.3 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 10.3 | no trial data cached |
| Mental impairment | 25 | 8.9 6.0–13.1ROR 9.0 · χ² 167 / p 1e-38 | 8.0 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Drug withdrawal syndrome | 91 | 8.9 7.2–10.8ROR 9.2 · χ² 628 / p 6e-139 | 8.6 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 | no trial data cached |
| Blood creatine phosphokinase increased | 30 | 8.9 6.2–12.6ROR 8.9 · χ² 201 / p 6e-46 | 8.1 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.8 | no trial data cached |
| Thinking abnormal | 19 | 8.8 5.6–13.7ROR 8.8 · χ² 123 / p 8e-29 | 7.7 EB05 5.0 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.3 | no trial data cached |
| Device failure | 15 | 8.5 5.2–14.1ROR 8.6 · χ² 92 / p 4e-22 | 7.2 EB05 4.5 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 15.2 | no trial data cached |
| Burning sensation | 67 | 8.2 6.5–10.4ROR 8.5 · χ² 420 / p 1e-93 | 7.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 | no trial data cached |
| Ataxia | 11 | 8.0 4.4–14.4ROR 8.0 · χ² 60 / p 4e-15 | 6.3 EB05 3.7 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Amnesia (memory loss) | 60 | 7.9 6.2–10.2ROR 8.1 · χ² 357 / p 7e-80 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Delirium | 31 | 7.7 5.5–11.0ROR 7.8 · χ² 175 / p 3e-40 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 9.5 | no trial data cached |
| Tinnitus (ringing in the ears) | 38 | 7.1 5.2–9.8ROR 7.2 · χ² 194 / p 2e-44 | 6.6 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Unresponsive to stimuli | 21 | 7.0 4.6–10.8ROR 7.1 · χ² 103 / p 2e-24 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Sedation | 21 | 6.9 4.5–10.6ROR 7.0 · χ² 101 / p 4e-24 | 6.1 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 | no trial data cached |
| Neuralgia | 19 | 6.8 4.3–10.6ROR 6.8 · χ² 88 / p 4e-21 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Coordination abnormal | 11 | 6.8 3.7–12.2ROR 6.8 · χ² 48 / p 2e-12 | 5.4 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Dysarthria (slurred speech) | 29 | 6.7 4.6–9.6ROR 6.7 · χ² 134 / p 3e-31 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 | no trial data cached |
| Paraesthesia oral | 11 | 6.6 3.7–11.9ROR 6.6 · χ² 47 / p 4e-12 | 5.3 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 | no trial data cached |
| Memory impairment | 104 | 6.5 5.4–7.9ROR 6.8 · χ² 484 / p 2e-107 | 6.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 7.1 | no trial data cached |
| Abnormal behaviour | 30 | 6.5 4.5–9.3ROR 6.6 · χ² 134 / p 3e-31 | 6.0 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Mood altered | 19 | 6.0 3.9–9.4ROR 6.1 · χ² 75 / p 3e-18 | 5.3 EB05 3.6 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 | no trial data cached |
| Back disorder | 11 | 5.8 3.2–10.5ROR 5.8 · χ² 39 / p 2e-10 | 4.8 EB05 2.9 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Agitation | 48 | 5.6 4.2–7.4ROR 5.7 · χ² 178 / p 6e-41 | 5.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 | no trial data cached |
| Feeling cold | 17 | 5.3 3.3–8.4ROR 5.3 · χ² 54 / p 8e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Abasia | 15 | 5.2 3.1–8.6ROR 5.2 · χ² 46 / p 5e-12 | 4.5 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Therapeutic response decreased | 36 | 5.1 3.7–7.1ROR 5.2 · χ² 117 / p 2e-27 | 4.8 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Pain | 362 | 5.1 4.6–5.6ROR 5.8 · χ² 1,215 / p 1e-266 | 5.0 EB05 4.6 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.3 | no trial data cached |
| Device issue | 313 | 31.0 28.0–34.4ROR 35.5 · χ² 9,074 / p <1e-300 | 30.9 EB05 28.1 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 57.1 | no trial data cached |
| Confusional state (confusion) | 205 | 10.9 9.6–12.5ROR 11.8 · χ² 1,851 / p <1e-300 | 10.8 EB05 9.6 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 11.5 | no trial data cached |
| Hallucination (hallucinations) | 168 | 19.4 16.7–22.4ROR 20.7 · χ² 2,912 / p <1e-300 | 19.3 EB05 17.0 · IC025 +3.9 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 21.0 | no trial data cached |
| Hallucination, auditory | 133 | 72.7 61.5–85.8ROR 76.8 · χ² 9,255 / p <1e-300 | 71.3 EB05 61.7 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 56.0 | no trial data cached |
| Memory impairment | 104 | 6.5 5.4–7.9ROR 6.8 · χ² 484 / p 2e-107 | 6.4 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 7.1 | no trial data cached |
| Somnolence (drowsiness) | 95 | 4.1 3.3–5.0ROR 4.2 · χ² 219 / p 6e-50 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.0 | no trial data cached |
| Drug withdrawal syndrome | 91 | 8.9 7.2–10.8ROR 9.2 · χ² 628 / p 6e-139 | 8.6 EB05 7.2 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.3 | no trial data cached |
| Hypoaesthesia (numbness) | 83 | 4.8 3.9–5.9ROR 4.9 · χ² 246 / p 1e-55 | 4.7 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.5 | no trial data cached |
| Muscle spasms | 79 | 3.7 3.0–4.6ROR 3.8 · χ² 155 / p 7e-36 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Overdose | 73 | 2.9 2.3–3.6ROR 3.0 · χ² 90 / p 1e-21 | 2.9 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 | no trial data cached |
| Burning sensation | 67 | 8.2 6.5–10.4ROR 8.5 · χ² 420 / p 1e-93 | 7.9 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 | no trial data cached |
| Mental status changes | 66 | 20.5 16.2–26.0ROR 21.1 · χ² 1,205 / p 3e-264 | 20.4 EB05 16.6 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.8 | no trial data cached |
| Psychotic disorder | 65 | 19.0 15.0–24.2ROR 19.5 · χ² 1,090 / p 2e-239 | 18.9 EB05 15.3 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.9 | no trial data cached |
| Amnesia (memory loss) | 60 | 7.9 6.2–10.2ROR 8.1 · χ² 357 / p 7e-80 | 7.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Muscle spasticity — n=35, PRR 24.4
- Delusion — n=24, PRR 13.4
- Tinnitus — n=38, PRR 7.1
- Unresponsive to stimuli — n=21, PRR 7.0
- Abnormal behaviour — n=30, PRR 6.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ziconotide?
In FDA FAERS, the most frequently co-reported reaction terms for Ziconotide are pain, confusional state, hallucination, hallucination, auditory, memory impairment, somnolence. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ziconotide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: 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.
Do FAERS signals prove that Ziconotide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID b025d8ed-937d-4597-9ad1-0b2f6e0ee5b1, effective 20250531; matched on
openfda.generic_name.exact:"ZICONOTIDE ACETATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 91 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.