What the label lists and what reports show
Ziconotide side effects
Ziconotide's FDA label: “The most frequently reported adverse reactions (≥ 25%) in clinical trials were dizziness, nausea, confusional state, nystagmus.” FAERS holds 2,432 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is device issue (313 reports).
- No generic listed
- Boxed warning
Check it at the source: the ziconotide FDA label on DailyMed (effective May 31, 2025, TerSera Therapeutics LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most frequently reported adverse reactions (≥ 25%) in clinical trials were dizziness, nausea, confusional state, nystagmus.
Table 1. Incidence of Adverse Reactions in Slow Titration Placebo-Controlled Trial by Percent (Events That Occurred in ≥ 5% of Patients and More Commonly with PRIALT than with Placebo)
| Reaction | PRIALT N=112 | Placebo N=108 |
|---|---|---|
| Any AE | 93 | 82 |
| Vertigo | 7 | 0 |
| Vision Blurred | 12 | 3 |
| Diarrhea | 18 | 15 |
| Nausea | 40 | 29 |
| Vomiting | 16 | 14 |
| Asthenia | 18 | 6 |
| Gait Abnormal | 14 | 2 |
| Pyrexia | 5 | 3 |
| Rigors | 7 | 5 |
| Sinusitis | 5 | 2 |
| Anorexia | 6 | 2 |
| Muscle Spasms | 6 | 4 |
| Pain in Limb | 5 | 2 |
| Amnesia | 8 | 0 |
| Ataxia | 14 | 1 |
| Dizziness | 46 | 13 |
| Dysarthria | 7 | 0 |
| Dysgeusia | 5 | 5 |
| Headache | 13 | 11 |
| Memory Impairment | 7 | 1 |
| Nystagmus | 8 | 0 |
| Somnolence | 17 | 10 |
| Tremor | 7 | 3 |
| Anxiety | 8 | 3 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most frequently reported adverse reactions (≥ 25%) in clinical trials were dizziness, nausea, confusional state, nystagmus. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact TerSera Therapeutics at 1-844-344-4035 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates in clinical practice. A total of 1254 adult patients received PRIALT as a continuous infusion in acute and severe chronic pain trials with an exposure of 662 patient-years. The mean duration of treatment was 193 days with 173 patients (14%) treated for at least 1 year. The average final dose was 17.6 mcg/day (0.73 mcg/hr). The most frequently reported adverse reactions (≥ 25%) in clinical trials were dizziness, nausea, confusional state and nystagmus. Slower titration of PRIALT may result in fewer serious adverse reactions and discontinuation of PRIALT for adverse reactions [ see Clinical Studies ( 14 ) and Dosage and Administration ( 2 ) ]. Adverse reactions during the slow titration placebo-controlled trial that occurred in 5% or greater of patients and more commonly with PRIALT than with placebo are summarized in Table 1 . Table 1.
Source: FDA drug label, 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
What do FAERS reports show?
2,432 reports list ziconotide among the medicines taken, 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. Of the 21 reactions below, 12 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ziconotide: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions