Ziconotide Side Effects

Some side effects of ziconotide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to ziconotide: intrathecal solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking ziconotide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• problems with memory, speech, walking, or thinking;

• feeling like you might pass out;

• double vision or other vision problems;

• new or worsening muscle pain, cramps, soreness, or weakness, and/or dark urine;

• unusual bleeding or signs of infection around the microinfusion entry or catheter exit sites;

• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, nausea, vomiting, and/or seizure (convulsions);

• extreme drowsiness or tired feeling, depressed mood;

• feeling paranoid, hostile, disoriented, or confused;

• strange sensations in your mouth;

• hallucinations, unusual thoughts or behavior, thoughts of hurting yourself; or

• feeling less alert, decreased consciousness (stupor or lack of response).

Less serious side effects of ziconotide may include:

• headache, joint pain;

• mild drowsiness or weakness;

• dizziness, spinning sensation;

• sleep problems, unusual dreams;

• stomach pain, diarrhea, constipation, loss of appetite;

• urinating less than usual; or

• loss of balance or coordination.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to ziconotide: intrathecal solution

Nervous system

Nervous system side effects including dizziness (up to 47%), confusion (18% to 33%), somnolence (up to 22%), memory impairment (7% to 22%), ataxia (up to 16%), abnormal gait (15%), speech disorder (9% to 14%), headache (13%), aphasia (8% to 12%), hypertonia (11%), nystagmus (8%), abnormal thinking (8%), amnesia (up to 8%), dysesthesia (7%), hallucinations (7%), nervousness (7%), paresthesia (7%), tremor (7%), dysarthria (7%), vertigo (up to 7%), and dysgeusia (5%) have been reported. Abnormal dreams, agitation, abnormal cerebrospinal fluid, depression, difficulty concentrating, dry mouth, emotional lability, hostility, hyperesthesia, incoordination, mental slowing, meningitis, neuralgia, paranoid reaction, decreased reflexes, stupor, and twitching have been reported in at least 2% of patients participating in the clinical trials. Cerebrovascular accident, grand mal convulsion, meningitis, myoclonus, and rhabdomyolysis have been reported in less than 2% of patients participating in the clinical trials.

A 42% incidence of confusion has been reported in patients 65 years of age and older. A 29% incidence of confusion has been reported in patients under 65 year of age.

Cognitive impairment may appear gradually after several weeks of treatment. The various cognitive effects of ziconotide are generally reversible within 2 weeks after drug discontinuation.

Gastrointestinal

Gastrointestinal side effects including nausea (up to 41%), diarrhea (up to 19%), vomiting (up to 16%), and anorexia (up to 10%) have been reported. Constipation, gastrointestinal disorder, nausea, nausea with vomiting, and dyspepsia have been reported in at least 2% of patients participating in the clinical trials.

Hepatic

Hepatic side effects have included serum creatine kinase (CK) levels above the upper limit of normal (40%). Eleven percent of patients had serum CK that were 3 or more times the upper limit of normal.

In cases where CK was fractionated, only the muscle isoenzyme (MM) was elevated.

General

General side effects including asthenia (up to 22%), headache (15%), abnormal gait (14%), pain (11%), rigors (7%), and fever (up to 7%) have been reported. Abdominal pain, accidental injury, back pain, catheter complication, cellulitis, chest pain, infection, malaise, neck pain, neck rigidity, and flu syndrome have been reported in at least 2% of patients participating in the clinical trials.

Psychiatric

Psychiatric side effects including confusional state (15%), hallucinations (12%), anxiety (8%), insomnia (6%), paranoid reactions (3%), hostility (2%), delirium (2%), psychosis (1%), and manic reactions (0.4%) have been reported.

Ocular

Ocular side effects including blurred vision (12%) and abnormal vision (10%) have been reported. Diplopia and photophobia have been reported in at least 2% of patients participating in the clinical trials.

Local

Local side effects have included catheter site pain, pump site pain, pump site complication, and pump site mass which have been reported in at least 2% of patients participating in the clinical trials.

Cardiovascular

Cardiovascular side effects including hypertension, hypotension, postural hypotension, syncope, tachycardia, and vasodilation have been reported in at least 2% of patients participating in the clinical trials. Atrial fibrillation and abnormal cardiograms have been reported in less than 2% of patients participating in the clinical trials.

Hematologic

Hematologic side effects including anemia and ecchymosis have been reported in at least 2% of patients participating in the clinical trials.

Metabolic

Metabolic side effects including increased creatinine phosphokinase, dehydration, edema, hypokalemia, peripheral edema, and weight loss have been reported in at least 2% of patients participating in the clinical trials.

Musculoskeletal

Musculoskeletal side effects including arthralgia, arthritis, leg cramps, myalgia, muscle spasm, limb pain, and myasthenia have been reported in at least 2% of patients participating in the clinical trials.

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.

Dermatologic

Dermatologic side effects including cutaneous surgical complication, dry skin, pruritus, rash, skin disorder, and sweating have been reported in at least 2% of patients participating in the clinical trials.

Other

Other side effects including vertigo have been reported in 7% of patients. Taste perversion and tinnitus have been reported in at least 2% of patients participating in the clinical trials. Sepsis and suicidal ideations have been reported in less than 2% of patients participating in the clinical trials.

Renal

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.

Genitourinary

Genitourinary side effects including urinary retention (9%) have been reported.

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