Prialt Side Effects

Generic Name: ziconotide

Please note - some side effects for Prialt may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Prialt - for the Consumer

Prialt

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Prialt:

Abnormal walking; back pain; bad taste in mouth; burning, aching, tingling sensation on the skin; constipation; diarrhea; dizziness; dry skin; feeling of a whirling motion; incoordination; increased cough; loss of appetite; muscle tension; pain; pain at insertion site; rapid, jerky eye movements; ringing in the ears; runny nose; skin irritation; sleepiness; sore throat; stomach pain; sweating; vision changes.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thinking; anxiety; change in mental state (eg, lack of energy, confusion, disorientation); change in mood or perception (eg, hallucinations; unusual sensations in the mouth; paranoia; hostility; delirium; manic reactions; psychosis); chest pain; dark urine; depression; fainting; fever; flu-like symptoms; headache; inability to empty the bladder; memory problems or memory loss; muscle cramps; muscle or joint pain; nausea; nervousness; pounding in the chest; seizures; speech problems; stiff neck; stupor; suicidal thoughts or behaviors; unresponsiveness; urination problems; vomiting; weakness.

Prialt Side Effects - for the Professional

Prialt

The safety of IT Prialt administered as a continuous infusion has been evaluated in 1254 patients participating in acute and severe chronic pain trials. The duration of treatment has ranged from a one-hour IT infusion to treatment lasting for more than 7.5 years. The mean duration of treatment was 193 days with 173 patients (14%) treated for at least 1 year. The average final dose was 17.6 mcg/day (0.73 mcg/hr).

The most frequently reported adverse events (≥25%) in the 1254 patients (662  patient years) in clinical trials were dizziness, nausea, confusional state and nystagmus. Serious adverse events and discontinuation of Prialt for adverse events are less frequent when the drug is slowly titrated over 21 days than with a faster titration schedule.

Table 2 summarizes the treatment-emergent adverse events with a frequency of 5% or greater in the Prialt-treated group from the one placebo-controlled trial using the slow titration schedule in patients with severe chronic pain. All events reported during the initial placebo-controlled period of the studies (21 days in the slow titration schedule) are tabulated, regardless of relationship to Prialt.

The following adverse events assessed as related to Prialt have been reported in 2% or greater of patients participating in the clinical studies (MedDRA preferred terms, by system organ class):

EAR AND LABYRINTH DISORDERS: vertigo; EYE DISORDERS: diplopia, vision blurred, visual disturbance NOS; GASTROINTESTINAL DISORDERS: abdominal pain NOS, constipation, diarrhea NOS, dry mouth, nausea, nausea aggravated, vomiting NOS; GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: asthenia, fall, fatigue, gait abnormal, lethargy, edema peripheral, pain NOS, pyrexia, rigors; INVESTIGATIONS: blood creatine phosphokinase increased; METABOLISM AND NUTRITION DISORDERS: anorexia, appetite decreased NOS; MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS: muscle cramp, muscle spasms, muscle weakness NOS, myalgia, pain in limb; NERVOUS SYSTEM DISORDERS: amnesia, aphasia, areflexia, ataxia, balance impaired NOS, burning sensation NOS, coordination abnormal NOS, disturbance in attention, dizziness, dizziness postural, dysarthria, dysgeusia, headache, hypoaesthesia, memory impairment, mental impairment NOS, nystagmus NOS, paraesthesia, sedation, somnolence, speech disorder, tremor; PSYCHIATRIC DISORDERS: agitation, anxiety, cognitive disorder NOS, confusional state, depression, depression aggravated, disorientation, hallucination NOS, hallucination auditory, hallucination visual, insomnia, irritability, mood disorder NOS, nervousness, paranoia; RENAL AND URINARY DISORDERS: dysuria, urinary hesitation, urinary retention; SKIN AND SUBCUTANEOUS TISSUE DISORDERS: pruritus, sweating increased; VASCULAR DISORDERS: hypotension NOS, orthostatic hypotension.

At less than 2%, the following medically important events were assessed by the clinical investigators as related to Prialt: acute renal failure, atrial fibrillation, cerebrovascular accident, sepsis, meningitis, psychotic disorder, suicidal ideation, respiratory distress, rhabdomyolysis, electrocardiogram abnormal, stupor, loss of consciousness, incoherent, clonic convulsion and grand mal convulsion. Rare instances of fatal pneumonia aspiration and suicide attempt were reported (<1%).

Side Effects by Body System

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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