Summary
Commonly reported side effects of ziconotide include: abnormal gait, aphasia, asthenia, dizziness, memory impairment, speech disturbance, ataxia, hypertonia, visual disturbance, and anorexia. Other side effects include: hallucination, nystagmus disorder, urinary retention, vertigo, abnormality in thinking, dysesthesia, fever, and paresthesia. Continue reading for a comprehensive list of adverse effects.
Applies to ziconotide: parenteral injection.
Warning
- Risk of severe psychiatric symptoms and neurological impairment.1 Do not use in patients with a history of psychosis.1 (See Nervous System Effects under Cautions.)
- Monitor for cognitive impairment, hallucinations, and changes in mood or consciousness.1
- Ziconotide therapy can be interrupted or discontinued abruptly without withdrawal effects.1
Side effects include:
Dizziness, nausea, confusion, headache, somnolence, nystagmus, asthenia, pain.
Serious adverse events and drug discontinuance due to adverse effects occur less frequently when the dosage is increased slowly over 21 days than when a faster dose titration schedule is used.
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
