Prialt

Last updated on RxList: 12/4/2020
Prialt Side Effects Center

What Is Prialt?

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.

What Are Side Effects of Prialt?

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

Dosage for Prialt

The dose of Prialt is determined by a physician and it is administered in a clinical setting.

What Drugs, Substances, or Supplements Interact with Prialt?

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 During Pregnancy and Breastfeeding

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.

Additional Information

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.

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Prialt Consumer Information

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

Ziconotide can affect your central nervous system and you may feel less alert. A person caring for you should seek emergency medical attention if you are hard to wake up.

Call your doctor at once if you have:

  • new or worsening muscle pain, soreness, or weakness, and/or dark urine;
  • a light-headed feeling (like you might pass out);
  • strange sensations in your mouth;
  • skin sores, itching, blisters, breakdown of the outer layer of skin;
  • confusion (especially in older adults);
  • problems with memory or thought;
  • unusual changes in mood or behavior--anger, aggression, paranoia, hallucinations, racing thoughts, risk-taking behavior;
  • symptoms of depression--feelings of low self-worth, loss of interest in things you once enjoyed, new sleep problems, thoughts about hurting yourself; or
  • symptoms of meningitis--fever, headache, neck stiffness, increased sensitivity to light, nausea, vomiting, confusion, or drowsiness.

Common side effects may include:

  • dizziness;
  • confusion;
  • nausea; or
  • unusual or involuntary eye movements.

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.

Read the entire detailed patient monograph for Prialt (Ziconotide)

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Prialt Professional 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 ClassMed DRA Preferred termPRIALT
N=112
Placebo
N=108
Percentage of Patients
Any AE9382
Ear and Labyrinth Disorders
Vertigo70
Eye Disorders
Vision Blurred123
Gastrointestinal Disorders
Diarrhea1815
Nausea4029
Vomiting1614
General Disorders and Administration Site Conditions
Asthenia186
Gait Abnormal142
Pyrexia53
Rigors75
Infections and Infestations
Sinusitis52
Metabolism and Nutrition Disorders
Anorexia62
Musculoskeletal and Connective Tissue Disorders
Muscle Spasms64
Pain in Limb52
Nervous System Disorders
Amnesia80
Ataxia141
Dizziness4613
Dysarthria70
Dysgeusia55
Headache1311
Memory Impairment71
Nystagmus80
Somnolence1710
Tremor73
Psychiatric Disorders
Anxiety83
Confusional State155
Insomnia69
Renal and Urinary Disorders
Urinary Retention90
Skin and Subcutaneous Disorders
Pruritis77
Sweating Increased56

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.

Postmarketing Experience

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)

© Prialt Patient Information is supplied by Cerner Multum, Inc. and Prialt Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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