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Ziconotide Side Effects

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

  • Anxiety
  • being forgetful
  • change in walking and balance
  • changes in patterns and rhythms of speech
  • clumsiness or unsteadiness
  • confusion
  • decrease in the frequency of urination
  • decrease in urine volume
  • delusions
  • dementia
  • 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
  • shivering
  • 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

Less Common

  • Aggressive or angry
  • chest pain
  • chills
  • confusion as to time, place, or person
  • convulsions
  • cough
  • dark-colored urine
  • dizziness
  • drowsiness
  • fainting
  • 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
  • fever
  • general feeling of illness
  • holding false beliefs that cannot be changed by fact
  • lightheadedness
  • muscle spasm or jerking of all extremities
  • muscle stiffness
  • rapid, shallow breathing
  • severe mood or mental changes
  • shortness of breath
  • sneezing
  • 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
  • wheezing

Rare

  • Actions that are out of control
  • changes in behavior
  • irritability
  • talking, feeling, and acting with excitement

Incidence Not Known

  • 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
  • diarrhea
  • dizziness
  • dizziness or lightheadedness
  • excessive muscle tone, tension, or tightness
  • feeling of constant movement of self or surroundings
  • headache
  • itching
  • lack or loss of strength
  • loss of appetite
  • loss of memory
  • nausea
  • pain in the arms or legs
  • problems with memory
  • sensation of spinning
  • sleepiness or unusual drowsiness
  • vomiting
  • weight loss

Less Common

  • Acid or sour stomach
  • back pain
  • bad, unusual, or unpleasant (after) taste
  • belching
  • bladder pain
  • bloody or cloudy urine
  • bruising
  • change in taste
  • congestion
  • constipation
  • continuing ringing or buzzing or other unexplained noise in the ears
  • crying
  • dehydration
  • depersonalization
  • depression
  • difficulty seeing at night
  • difficulty with moving
  • double vision
  • dry mouth
  • dry skin
  • dysphoria
  • euphoria
  • fainting
  • frequent urge to urinate
  • hearing loss
  • heartburn
  • hoarseness
  • increased sensitivity of the eyes to sunlight
  • increased sensitivity to pain or touch
  • indigestion
  • 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
  • sleeplessness
  • slow or fast heartbeat
  • stomach discomfort, upset, or pain
  • stuffy nose
  • sweating
  • 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

Incidence Not Known

  • 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

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

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

Frequency not reported: Sepsis

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 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]

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]

Other

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

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

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.[Ref]

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

Genitourinary

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

References

1. "Product Information. Prialt (ziconotide)." Elan Pharmaceutical/Athena Neurosciences Inc, South San Francisco, CA.

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.

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