"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Prialt Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Prialt (ziconotide) is a non-narcotic pain reliever used to treat severe chronic pain in people who cannot use or do not respond to standard pain-relieving medications. Common side effects of Prialt include dizziness, spinning sensation, drowsiness, nausea, headache, weakness, joint pain, sleep problems, unusual dreams, stomach pain, diarrhea, constipation, loss of appetite, urinating less than usual, or loss of balance or coordination.
The dose of Prialt is determined by a physician and it is administered in a clinical setting. Prialt may interact with other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), or diuretics (water pills). Tell your doctor all medications you use. Prialt should be used only when prescribed during pregnancy. It is unknown if this medication passes into breast milk, and it is unlikely to harm a nursing infant. Consult your doctor before breastfeeding.
Our Prialt (ziconotide) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Prialt in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: 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 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. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Prialt (Ziconotide)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Prialt Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: decreased alertness (unresponsiveness), confusion, memory problems, mental/mood changes (e.g., anxiety, depression, hallucinations, thoughts of suicide), new or worsening muscle pain/soreness, numbness/tingling, trouble speaking/swallowing, difficult/unsteady walking, trouble urinating, dark urine, vision changes.
A very serious infection (meningitis) may occur if the site of your infusion or the solution going into your spinal cord becomes contaminated. Symptoms of meningitis include mental changes (e.g., extreme drowsiness, confusion), high fever, seizures, severe headache, stiff neck, nausea, and vomiting. Seek immediate medical attention if any of these unlikely but very serious side effects occur.
A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Prialt (Ziconotide)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Prialt FDA Prescribing Information: Side Effects
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates in clinical practice.
A total of 1254 adult patients received PRIALT as a continuous infusion in acute and severe chronic pain trials with an exposure of 662 patient-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 reactions ( ≥ 25%) in clinical trials were dizziness, nausea, confusional state and nystagmus. Slower titration of PRIALT may result in fewer serious adverse reactions and discontinuation of PRIALT for adverse reactions [see Clinical Studies and DOSAGE AND ADMINISTRATION].
Adverse reactions during the slow titration placebo-controlled trial that occurred in 5% or greater of patients and more commonly with PRIALT than with placebo are summarized in Table 1.
Table 1: Incidence of Adverse Reactions in Slow
Titration Placebo-Controlled Trial by Percent (Events That Occurred in ≥ 5%
of Patients and More Commonly with PRIALT than with Placebo)
|MedDRA System Organ Class
MedDRA Preferred term
|Percentage of Patients|
|Ear and Labyrinth Disorders|
|General Disorders and Administration Site Conditions|
|Infections and Infestations|
|Metabolism and Nutrition Disorders|
|Musculoskeletal and Connective Tissue Disorders|
|Pain in Limb||5||2|
|Nervous System Disorders|
|Renal and Urinary Disorders|
|Skin and Subcutaneous Disorders|
Other Adverse Reactions Observed During Clinical Studies Of PRIALT
The following adverse reactions assessed as related to PRIALT have been reported in 2% or greater of patients participating in the clinical studies:
EYE DISORDERS: diplopia, visual disturbance
GASTROINTESTINAL DISORDERS: abdominal pain, constipation, dry mouth, nausea aggravated
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: fall, fatigue, lethargy, edema peripheral
INVESTIGATIONS: blood creatine phosphokinase increased
METABOLISM AND NUTRITION DISORDERS: appetite decreased
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS: muscle cramp, muscle weakness, myalgia, pain in limb
NERVOUS SYSTEM DISORDERS: aphasia, areflexia, balance impaired, burning sensation, coordination abnormal, disturbance in attention, dizziness postural, dysarthria, dysgeusia, hypoaesthesia, mental impairment, paraesthesia, sedation, speech disorder
PSYCHIATRIC DISORDERS: agitation, anxiety, cognitive disorder, confusional state, depression, depression aggravated, disorientation, hallucination, hallucination auditory, hallucination visual, insomnia, irritability, mood disorder, nervousness, paranoia
RENAL AND URINARY DISORDERS: dysuria, urinary hesitation
VASCULAR DISORDERS: hypotension, orthostatic hypotension.
The following medically important adverse reactions occurred in less than 2% of patients 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, clonic convulsion and grand mal convulsion. Fatal aspiration pneumonia and suicide attempt were reported in less than 1% of patients.
The following adverse events have been reported during post-approval use of PRIALT. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Hypersensitivity reactions including angioedema, serious skin reactions including bullous dermatitis, skin ulcers, skin exfoliation, and burning skin sensation.
Read the entire FDA prescribing information for Prialt (Ziconotide)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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