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Ziconotide Side Effects

Medically reviewed by Drugs.com. Last updated on May 22, 2023.

Applies to ziconotide: intrathecal solution.

Warning

Intrathecal route (Solution)

Ziconotide is contraindicated in patients with a preexisting history of psychosis. Severe psychiatric symptoms and neurological impairment may occur during treatment with ziconotide. Monitor all patients frequently for evidence of cognitive impairment, hallucinations, or changes in mood or consciousness. Discontinue ziconotide therapy in the event of serious neurological or psychiatric signs or symptoms.

Serious side effects of Ziconotide

Along with its needed effects, ziconotide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ziconotide:

More common

Less common

Rare

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking ziconotide:

Symptoms of overdose

Other side effects of Ziconotide

Some side effects of ziconotide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Incidence not known

For Healthcare Professionals

Applies to ziconotide: intrathecal solution.

General

The most common reported adverse reactions have included dizziness, nausea, confusional state, and nystagmus.[Ref]

Psychiatric

Very common (10% or more): Confusional state (15%)

Common (1% to 10%): Amnesia, memory impairment, anxiety, insomnia, agitation, cognitive disorder, depression, depression aggravated, disorientation, hallucination, hallucination auditory, hallucination visual, irritability, mood disorder, nervousness, paranoia

Uncommon (0.1% to 1%): Suicide attempt

Frequency not reported: Psychotic disorder, suicidal ideation[Ref]

Psychotic disorder and suicide ideation occurred in less than 2% of patients; suicide attempt was reported in less than 1% of patients; these events were assessed by clinical investigators as related to drug therapy.[Ref]

Nervous system

Very common (10% or more): Dizziness, (40%), ataxia (14%), headache (13%), somnolence (17%)

Common (1% to 10%): dysarthria, dysgeusia, nystagmus, tremor, aphasia, areflexia, balance impaired, burning sensation, coordination abnormal, disturbance in attention, dizziness postural, hypnoanesthesia, mental impairment, paresthesia, sedation, speech disorder

Frequency not reported: Cerebrovascular accident, meningitis, stupor, loss of consciousness, clonic convulsion and grandmal convulsion[Ref]

Cerebrovascular accident, meningitis, stupor, loss of consciousness, clonic convulsion and grandmal convulsion occurred in less than 2% of patients; these events were assessed by clinical investigators as related to drug therapy.[Ref]

Musculoskeletal

Rhabdomyolysis occurred in less than 2% of patients and was assessed by clinical investigators as related to drug therapy[Ref]

Very common (10% or more): Abnormal gait (14%)

Common (1% to 10%): Muscle spasms, pain in limb, increased blood creatine phosphokinase, muscle cramp, muscle weakness, myalgia

Frequency not reported: Rhabdomyolysis[Ref]

Immunologic

Frequency not reported: Sepsis

Sepsis occurred in less than 2% of patients and was assessed by clinical investigators as related to drug therapy.

Gastrointestinal

Very common (10% or more): Nausea (40%), diarrhea (18%), vomiting (16%)

Common (1% to 10%): Abdominal pain, constipation, dry mouth, nausea aggravated[Ref]

Dermatologic

Common (1% to 10%): Pruritus, increased sweating

Postmarketing reports: Hypersensitivity reactions including angioedema, serious skin reactions including bullous dermatitis, skin ulcers, skin exfoliation, and burning skin sensation[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions including angioedema, serious skin reactions including bullous dermatitis, skin ulcers, skin exfoliation, and burning skin sensation

Ocular

Common (1% to 10%): Blurred vision, diplopia, visual disturbance[Ref]

Cardiovascular

Atrial fibrillation and abnormal electrocardiogram were reported in less than 2% of patient; these events were assessed by clinical investigators as related to drug therapy.[Ref]

Common (1% to 10%): Peripheral edema, hypotension, orthostatic hypotension

Frequency not reported: Atrial fibrillation[Ref]

Metabolic

Common (1% to 10%): Anorexia, decreased appetite[Ref]

Respiratory

Respiratory side effects including bronchitis, increased cough, dyspnea, lung disorder, pharyngitis, pneumonia, rhinitis, and sinusitis have been reported in at least 2% of patients participating in the clinical trials. Respiratory distress has been reported in less than 2% of patients participating in the clinical trials. Fatal aspiration pneumonia has been reported in less than 1% of patients participating in clinical trials.[Ref]

Respiratory distress occurred in less than 2% of patients; Fatal aspiration pneumonia was reported in less than 1% of patients; these were assessed by clinical investigators as related to drug therapy.[Ref]

Other

Very common (10% or more): Asthenia (18%)

Common (1% to 10%): Vertigo, pyrexia, rigors, fall, fatigue, lethargy[Ref]

Renal

Acute renal failure occurred in less than 2% of patients and was assessed by clinical investigators as related to drug therapy.[Ref]

Renal side effects including urinary retention (9%) have been reported. Urinary incontinence, urinary tract infection, and impaired urination have been reported in at least 2% of patients participating in the clinical trials. Acute kidney failure has been reported in less than 2% of patients participating in the clinical trials.[Ref]

Genitourinary

Common (1% to 10%): Urinary retention, dysuria, urinary hesitation

References

1. Product Information. Prialt (ziconotide). Elan Pharmaceutical/Athena Neurosciences Inc. 2005.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.