Prialt Side Effects

Generic name: ziconotide

Medically reviewed by Drugs.com. Last updated on May 22, 2024.

Note: This document provides detailed information about Prialt Side Effects associated with ziconotide. Some dosage forms listed on this page may not apply specifically to the brand name Prialt.

Applies to ziconotide: intrathecal solution.

Precautions

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you or your caregiver notice any of these adverse effects, tell your doctor right away.

Serious infection or meningitis can occur if the catheter of this medicine becomes disconnected. It is very important that you follow your doctor's instructions about the care of the catheter and the use of the infusion pump.

If you or your caregiver notice any signs of meningitis such as confusion, drowsiness, fever, headache, nausea or vomiting, seizures, or stiff neck, call your doctor right away.

This medicine may cause some people to become dizzy, drowsy, confused, disoriented, clumsy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before you take any of the medicines listed above while you are using this medicine.

Tell your doctor right away if you have unexplained muscle pain or weakness, loss of strength or energy, and with or without a darkened urine. Your doctor may need to reduce the dose of your medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Prialt

Along with its needed effects, ziconotide (the active ingredient contained in Prialt) 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:

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

Other side effects of Prialt

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:

For healthcare professionals

Applies to ziconotide: intrathecal solution.

General adverse events

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

• 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]

Rhabdomyolysis occurred in less than 2% of patients and was assessed by clinical investigators as related to drug therapy^[Ref]

Immunologic

• Frequency not reported: Sepsis

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

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

• Common (1% to 10%): Peripheral edema, hypotension, orthostatic hypotension
• Frequency not reported: Atrial fibrillation^[Ref]

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]

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

See also:

Further information

Prialt side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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