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
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
- being forgetful
- change in walking and balance
- changes in patterns and rhythms of speech
- clumsiness or unsteadiness
- decrease in the frequency of urination
- decrease in urine volume
- difficulty in passing urine (dribbling)
- difficulty with speaking
- feeling unusually cold
- painful urination
- problems with speech or speaking
- seeing, hearing, or feeling things that are not there
- shakiness and unsteady walk
- shakiness in the legs, arms, hands, or feet
- slurred speech
- thoughts of killing oneself
- trembling or shaking of the hands or feet
- uncontrolled eye movements
- unsteadiness, trembling, or other problems with muscle control or coordination
- Aggressive or angry
- chest pain
- confusion as to time, place, or person
- dark-colored urine
- fast heartbeat
- fearfulness, suspiciousness, or other mental changes
- feeling that others are watching you or controlling your behavior
- feeling that others can hear your thoughts
- general feeling of illness
- holding false beliefs that cannot be changed by fact
- muscle spasm or jerking of all extremities
- muscle stiffness
- rapid, shallow breathing
- severe mood or mental changes
- shortness of breath
- sore throat
- stiff neck or back
- tightness in the chest
- troubled breathing
- trouble in concentration
- trouble in sleeping
- unusual behavior unusual excitement, nervousness, or restlessness
- unusual tiredness or weakness
- Actions that are out of control
- changes in behavior
- talking, feeling, and acting with excitement
- Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
Get emergency help immediately if any of the following symptoms of overdose occur while taking ziconotide:Symptoms of overdose
- Decreased awareness or responsiveness
- severe sleepiness
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
- Blurred vision
- crawling feelings
- dizziness or lightheadedness
- excessive muscle tone, tension, or tightness
- feeling of constant movement of self or surroundings
- lack or loss of strength
- loss of appetite
- loss of memory
- pain in the arms or legs
- problems with memory
- sensation of spinning
- sleepiness or unusual drowsiness
- weight loss
- Acid or sour stomach
- back pain
- bad, unusual, or unpleasant (after) taste
- bladder pain
- bloody or cloudy urine
- change in taste
- continuing ringing or buzzing or other unexplained noise in the ears
- difficulty seeing at night
- difficulty with moving
- double vision
- dry mouth
- dry skin
- frequent urge to urinate
- hearing loss
- increased sensitivity of the eyes to sunlight
- increased sensitivity to pain or touch
- loss of bladder control
- loss of taste
- lung disorder
- nerve pain
- pain in the joints
- pain or tenderness around the eyes and cheekbones
- pale skin
- pounding in the ears
- quick to react or overreact emotionally
- rapidly changing moods
- red, scaly, swollen, or peeling areas of the skin
- redness or pain at the catheter site
- runny nose
- severe muscle stiffness
- shortness of breath or troubled breathing
- slow or fast heartbeat
- stomach discomfort, upset, or pain
- stuffy nose
- swelling or redness in the joints
- tender, swollen glands in the neck
- tightness of the chest or wheezing
- trouble with swallowing
- unusual bleeding or bruising
- unusual tiredness or weakness
- voice changes
- warmth on the skin
- weakness or heaviness in the legs
- Burning sensation on the skin
- flaking and falling off of skin
- skin blisters
- sores on the skin
For Healthcare Professionals
Applies to ziconotide: intrathecal solution
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 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 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 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 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 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 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 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 side effects including anemia and ecchymosis have been reported in at least 2% of patients participating in the clinical trials.
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 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 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 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 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 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 side effects including urinary retention (9%) have been reported.
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