DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Prialt (Ziconotide) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prialt (Ziconotide) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (56)
Death (4)
Life Threatening Events (2)
Disability (2)

Reports by Reaction Type

Hallucination (6)Thrombocytopenia (6)Agitation (5)Weight Decreased (5)Burning Sensation (5)Psychotic Disorder (5)Abdominal Pain (4)Confusional State (4)Abortion Spontaneous (4)Overdose (4)Hypersomnia (4)Maternal Exposure During Pregnancy (4)

Below are a few examples of reports where side effects / adverse reactions may be related to Prialt (Ziconotide). For a complete list or a specific selection of reports, please use the links above.

Possible Prialt side effects in 77 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02

Patient: 77 year old male, weighing 102.3 kg (225.1 pounds)

Reactions: Left Ventricular Hypertrophy, Device Related Infection, Cardiac Failure Congestive

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prialt
    Dosage: 0.087 ug, once/hour, intrathecal, 0.09 ug, once/hour, intrathecal, 0.06 ug, once/hour, intrathecal
    Indication: Intervertebral Disc Degeneration
    Start date: 2012-07-02
    End date: 2012-07-11

Prialt
    Dosage: 0.087 ug, once/hour, intrathecal, 0.09 ug, once/hour, intrathecal, 0.06 ug, once/hour, intrathecal
    Indication: Intervertebral Disc Degeneration
    Start date: 2012-07-11
    End date: 2012-07-18

Prialt
    Dosage: 0.087 ug, once/hour, intrathecal, 0.09 ug, once/hour, intrathecal, 0.06 ug, once/hour, intrathecal
    Indication: Intervertebral Disc Degeneration
    Start date: 2012-06-20
    End date: 2012-07-02

Other drugs received by patient: Clonidine; Vitamin B12; Bethanechol Cloride (Bethanechol Chloride); Albuterol; Ambien; Percocet; Aspirin Children (Acetylsalicylic Acid); Ferrous Gluconate (Ferrous Gluconate); Coreg; Flunisolide Acetate (Flunisolide Acetate); Spiriva; Vitamin B6; Metfformin Hydrochloride; Advair HFA; Doxazosin Mesylate; Neurontin; Omeprazole



Possible Prialt side effects in 25 year old female

Reported by a physician from United States on 2012-07-27

Patient: 25 year old female

Reactions: Maternal Exposure During Pregnancy, Benign Hydatidiform Mole, Abortion Spontaneous

Drug(s) suspected as cause:
Prialt



Possible Prialt side effects in 25 year old female

Reported by a physician from United States on 2012-07-27

Patient: 25 year old female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Prialt



Possible Prialt side effects in female

Reported by a physician from United States on 2012-07-13

Patient: female, weighing 100.0 kg (220.0 pounds)

Reactions: Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bupivacaine HCL
    Dosage: unk, mg, once/hour, intrathecal

Fentanyl
    Dosage: unk ug, once/hour, intrathecal

Prialt
    Dosage: 0.2 ug, once/hour, intrathecal
    Indication: Diabetic Neuropathy
    Start date: 2011-07-01
    End date: 2012-05-22



Possible Prialt side effects in 53 year old female

Reported by a physician from United States on 2012-07-11

Patient: 53 year old female

Reactions: Muscle Spasticity

Drug(s) suspected as cause:
Baclofen
    Dosage: ug, once/hour, intrathecal

Prialt
    Dosage: ug, once/hour, intrathecal



Possible Prialt side effects in 37 year old male

Reported by a consumer/non-health professional from United States on 2012-07-10

Patient: 37 year old male, weighing 99.8 kg (219.5 pounds)

Reactions: Brain Injury, Anxiety, Mental Impairment, Psychotic Disorder, Paranoia, Dehydration, Mental Status Changes, Memory Impairment, Hallucination

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prialt



Possible Prialt side effects in 44 year old male

Reported by a physician from France on 2012-07-09

Patient: 44 year old male

Reactions: Vomiting, Nausea, Drug Hypersensitivity, Drug Intolerance, Vertigo

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prialt

Other drugs received by patient: Mirtazapine; Acetaminophen; Monocrixo (Tramadol Hydrochloride)



Possible Prialt side effects in 58 year old male

Reported by a physician from Germany on 2012-07-09

Patient: 58 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: Pancreatitis Acute, Pancreatitis Relapsing

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prialt



Possible Prialt side effects in 61 year old male

Reported by a physician from United States on 2012-07-09

Patient: 61 year old male, weighing 91.0 kg (200.2 pounds)

Reactions: Back Pain, Confusional State, Pneumonia, Mental Status Changes, Fall, Fatigue, Sepsis, Asthenia, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clonidine
    Dosage: unk ug, once/hour, intrathecal

Prialt
    Dosage: 0.04-0.0625 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2011-11-01
    End date: 2012-06-01

Prialt
    Dosage: 0.04-0.0625 ug, once/hour, intrathecal
    Indication: Back Pain
    Start date: 2011-11-01
    End date: 2012-06-01

Sufentanil Citrate
    Dosage: unk g, once/hour, intrathecal

Other drugs received by patient: Roxicodone; Trazdone; Novolog; Neurontin; Amitriptyline Hydrochloride; Enalapril Maleate; Atenolol; Lantus



Possible Prialt side effects in 43 year old male

Reported by a physician from France on 2012-07-09

Patient: 43 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Agitation, Persecutory Delusion, Paranoia, Skin Exfoliation, Drug Withdrawal Syndrome, Delirium, Tremor, Anxiety, Burning Sensation, Nephrolithiasis, Overdose, Visual Impairment, Asthenia, Hallucination

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Prialt
    Dosage: 0.05 ug, once/hour, intrathecal ; 0.03 ug, once/hour, intrathecal ; 0.2 g, once/hour, intrathecal
    Indication: Neuralgia
    Start date: 2011-05-18
    End date: 2011-06-01

Prialt
    Dosage: 0.05 ug, once/hour, intrathecal ; 0.03 ug, once/hour, intrathecal ; 0.2 g, once/hour, intrathecal
    Indication: Neuralgia
    Start date: 2011-06-01
    End date: 2012-01-26

Prialt
    Dosage: 0.05 ug, once/hour, intrathecal ; 0.03 ug, once/hour, intrathecal ; 0.2 g, once/hour, intrathecal
    Indication: Neuralgia
    Start date: 2012-01-26

Other drugs received by patient: Tegretol



Possible Prialt side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: female

Reactions: Thinking Abnormal, Sleep Disorder, Catatonia, Hallucination, Amnesia, Loss of Consciousness

Drug(s) suspected as cause:
Morphine Sulfate
    Dosage: 0.54 mg, once/hour, intrathecal

Prialt
    Dosage: 0.01 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2009-04-07
    End date: 2009-05-01

Prialt
    Dosage: 0.01 ug, once/hour, intrathecal
    Indication: Spinal Fusion Surgery
    Start date: 2009-04-07
    End date: 2009-05-01



Possible Prialt side effects in 50 year old male

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: 50 year old male

Reactions: Drug Hypersensitivity, Headache, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prialt



Possible Prialt side effects in 29 year old male

Reported by a physician from Austria on 2012-06-27

Patient: 29 year old male, weighing 56.0 kg (123.2 pounds)

Reactions: Weight Decreased, Abdominal Pain, Alcohol Abuse, General Physical Health Deterioration, Gastritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen
    Dosage: 41.67 ug, once/hour, intrathecal, 45.84 ug, once/hour, 41.67 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2010-03-31
    End date: 2010-05-03

Baclofen
    Dosage: 41.67 ug, once/hour, intrathecal, 45.84 ug, once/hour, 41.67 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2010-05-03

Baclofen
    Dosage: 41.67 ug, once/hour, intrathecal, 45.84 ug, once/hour, 41.67 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2009-09-17
    End date: 2010-03-31

Prialt
    Dosage: see image
    Indication: Pain
    Start date: 2007-07-05

Prialt
    Dosage: see image
    Indication: Pain
    Start date: 2009-09-17
    End date: 2010-03-31

Prialt
    Dosage: see image
    Indication: Pain
    Start date: 2010-05-03

Prialt
    Dosage: see image
    Indication: Pain
    Start date: 2010-03-31
    End date: 2010-05-03

Other drugs received by patient: Boniva; Amitriptyline HCL; Gewacalm (Diazepam); Mirtazapine; Seroquel XR; Cymbalta



Possible Prialt side effects in female

Reported by a physician from United States on 2012-06-25

Patient: female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Prialt



Possible Prialt side effects in female

Reported by a physician from United States on 2012-06-25

Patient: female

Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous

Drug(s) suspected as cause:
Prialt



Possible Prialt side effects in 62 year old male

Reported by a physician from France on 2012-06-14

Patient: 62 year old male, weighing 65.0 kg (143.0 pounds)

Reactions: Weight Decreased, Dysphagia, Oral Pain, Balance Disorder, Nystagmus, Allodynia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Morphine Sulfate
    Dosage: 0.03 mg, once/hour, intrathecal

Prialt
    Dosage: see image
    Start date: 2012-01-01

Prialt
    Dosage: see image
    Start date: 2012-03-01

Prialt
    Dosage: see image
    Start date: 2012-03-01
    End date: 2012-03-01

Prialt
    Dosage: see image
    End date: 2012-05-07

Prialt
    Dosage: see image
    Start date: 2012-05-07
    End date: 2012-05-14

Other drugs received by patient: Perindopril Erbumine; Oxycontin; Avodart; Tranxene; Cymbalta; Amitriptyline HCL; Lyrica; Aspirin; Glucophage



Possible Prialt side effects in 29 year old male

Reported by a physician from Austria on 2012-05-25

Patient: 29 year old male, weighing 56.0 kg (123.2 pounds)

Reactions: Weight Decreased, Abdominal Pain, General Physical Health Deterioration, Gastritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen
    Dosage: 41.67;45.84; ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2009-09-17
    End date: 2010-03-31

Baclofen
    Dosage: 41.67;45.84; ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2010-03-31
    End date: 2010-05-03

Baclofen
    Dosage: 41.67;45.84; ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2010-05-03

Prialt
    Dosage: 0.21;0.23;0.25 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2009-09-17
    End date: 2010-03-31

Prialt
    Dosage: 0.21;0.23;0.25 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2010-03-31
    End date: 2010-05-03

Prialt
    Dosage: 0.21;0.23;0.25 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2010-05-03

Prialt
    Dosage: 0.21;0.23;0.25 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2007-07-05

Other drugs received by patient: Boniva; Amitriptyline HCL; Gewacalm (Diazepam); Seroquel XR; Cymbalta; Mirtazapine



Possible Prialt side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-17

Patient: female

Reactions: Fluid Retention

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Bupivacaine HCL
    Dosage: ukn mg, once/hour, intrathecal

Fentanyl
    Dosage: unk ug, once/hour, intrathecal

Prialt
    Dosage: 0.2 ug, once/hour, intrathecal
    Indication: Diabetic Neuropathy
    Start date: 2011-07-01



Possible Prialt side effects in 43 year old male

Reported by a physician from France on 2012-05-17

Patient: 43 year old male, weighing 81.0 kg (178.2 pounds)

Reactions: Agitation, Persecutory Delusion, Delirium, Mania, Anxiety, Burning Sensation, Overdose, Dysuria, Perineal Pain, Hallucination

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Prialt



Possible Prialt side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-01

Patient: female

Reactions: Abdominal Discomfort, Burning Sensation, Syncope, Glossodynia, Pain, Gastrointestinal Hypomotility, Headache, Deep Vein Thrombosis

Drug(s) suspected as cause:
Bupivacaine HCL
    Dosage: unk mg, once/hour, intrathecal

Fentanyl
    Dosage: unk ug, once/hour, intrathecal

Morphine
    Dosage: unk mg, once/hour, intrathecal

Prialt
    Dosage: unk ug, once/hour, intrathecal



Possible Prialt side effects in 37 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-26

Patient: 37 year old female, weighing 102.0 kg (224.4 pounds)

Reactions: Confusional State, Skin Burning Sensation, Crying

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prialt



Possible Prialt side effects in 29 year old male

Reported by a physician from Austria on 2012-04-26

Patient: 29 year old male, weighing 56.0 kg (123.2 pounds)

Reactions: Abdominal Pain, Weight Decreased, General Physical Health Deterioration, Gastritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Baclofen
    Dosage: 41.67 ug, once/hour, intrathecal 45.84 once/hour, intrathecal
    Indication: Pain
    Start date: 2009-09-17
    End date: 2010-03-31

Baclofen
    Dosage: 41.67 ug, once/hour, intrathecal 45.84 once/hour, intrathecal
    Indication: Pain
    Start date: 2010-03-31
    End date: 2010-05-03

Baclofen
    Dosage: 41.67 ug, once/hour, intrathecal 45.84 once/hour, intrathecal
    Indication: Pain
    Start date: 2010-05-03

Prialt
    Dosage: 0.21 ug, once/hour, intrathecal 0.23 ug, once/hour, intrathecal 0.25 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2007-07-05

Prialt
    Dosage: 0.21 ug, once/hour, intrathecal 0.23 ug, once/hour, intrathecal 0.25 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2010-05-03

Prialt
    Dosage: 0.21 ug, once/hour, intrathecal 0.23 ug, once/hour, intrathecal 0.25 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2010-03-31
    End date: 2010-05-03

Prialt
    Dosage: 0.21 ug, once/hour, intrathecal 0.23 ug, once/hour, intrathecal 0.25 ug, once/hour, intrathecal
    Indication: Pain
    Start date: 2009-09-17
    End date: 2010-03-31

Other drugs received by patient: Amitriptyline HCL; Boniva; Mirtazapine; Gewacalm (Diazepam); Cymbalta



Possible Prialt side effects in male

Reported by a physician from United States on 2012-04-25

Patient: male

Reactions: Hypoventilation, Unresponsive To Stimuli, Hypercapnia, Lethargy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Prialt

Other drugs received by patient: Haldol



Possible Prialt side effects in 83 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-18

Patient: 83 year old female

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Morphine
    Dosage: once/hour, intrathecal
    Indication: Pain

Prialt
    Dosage: unk ug, once/hour, intrathecal; unk mcg, once/hour, intrathecal
    Indication: Pain



Possible Prialt side effects in 47 year old female

Reported by a physician from United States on 2012-04-11

Patient: 47 year old female

Reactions: Confusional State, Vomiting, Nausea, Anaemia, Dehydration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fentanyl
    Dosage: unk ug, once/hour, intrathecal

Prialt
    Dosage: 0.3 ug, once/hour, intrathecal 0.018 ug, once/hour, intrathecal
    Start date: 2012-03-22
    End date: 2012-03-27

Prialt
    Dosage: 0.3 ug, once/hour, intrathecal 0.018 ug, once/hour, intrathecal
    Start date: 2012-03-27



Possible Prialt side effects in 44 year old male

Reported by a physician from United States on 2012-03-23

Patient: 44 year old male

Reactions: Agitation, Hallucination, Auditory, Mental Status Changes, Aggression, Balance Disorder, Hallucination, Visual, DRY Mouth, Screaming, Asthenia, Crying

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prialt
    Dosage: 0.125 ug, once/hour, intrathecal, 0.048 ug/hour, intrathecal
    Indication: Complex Regional Pain Syndrome
    Start date: 2012-02-20
    End date: 2012-02-28

Prialt
    Dosage: 0.125 ug, once/hour, intrathecal, 0.048 ug/hour, intrathecal
    Indication: Pain
    Start date: 2012-02-20
    End date: 2012-02-28

Prialt
    Dosage: 0.125 ug, once/hour, intrathecal, 0.048 ug/hour, intrathecal
    Indication: Complex Regional Pain Syndrome
    Start date: 2012-01-01
    End date: 2012-02-20

Prialt
    Dosage: 0.125 ug, once/hour, intrathecal, 0.048 ug/hour, intrathecal
    Indication: Pain
    Start date: 2012-01-01
    End date: 2012-02-20

Other drugs received by patient: Opana (Oxymorphone Hydrochloride) Hydrocodone W / Acetaminophen (Hydroco



Possible Prialt side effects in 50 year old female

Reported by a physician from Germany on 2012-03-23

Patient: 50 year old female, weighing 80.0 kg (176.0 pounds)

Reactions: Agitation, Fear of Death, Hallucination, Auditory, Pain, Feeling Cold, Palpitations, Blood Pressure Inadequately Controlled, Screaming, Merycism, Depression, Persecutory Delusion, Chest Discomfort, Restlessness, Urinary Tract Infection, Radicular Syndrome, Hypertensive Crisis, Psychotic Disorder, Panic Attack, Micturition Disorder, Hallucination, Visual, Insomnia, Suicide Attempt, Mental Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prialt
    Dosage: see image
    Indication: Pain
    Start date: 2011-04-14
    End date: 2011-05-02

Prialt
    Dosage: see image
    Indication: Pain
    Start date: 2011-05-16
    End date: 2011-06-17

Prialt
    Dosage: see image
    Indication: Pain
    Start date: 2011-05-02
    End date: 2011-05-06

Prialt
    Dosage: see image
    Indication: Pain
    Start date: 2011-05-06
    End date: 2011-05-16

Other drugs received by patient: Palexia (Tapentadol Hydrochloride); Antipsychotics



Possible Prialt side effects in 40 year old male

Reported by a physician from United States on 2012-03-20

Patient: 40 year old male

Reactions: Mental Impairment, Psychotic Disorder, Disorientation, Pyrexia, Muscle Spasticity

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prialt

Other drugs received by patient: Drug Used IN Diabetes



Possible Prialt side effects in 66 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-13

Patient: 66 year old male, weighing 76.2 kg (167.6 pounds)

Reactions: Photosensitivity Reaction, Eye Irritation, Eye Swelling, DRY Eye

Drug(s) suspected as cause:
Dilaudid
    Dosage: once/hour, intrathecal

Prialt
    Dosage: 0.02 ug, once/hour, intrathecal
    Indication: Lumbar Radiculopathy
    Start date: 2011-12-28
    End date: 2012-02-13

Prialt
    Dosage: 0.02 ug, once/hour, intrathecal
    Indication: Post Laminectomy Syndrome
    Start date: 2011-12-28
    End date: 2012-02-13

Other drugs received by patient: Humalog; Synthroid; Lidoderm; Prednisone TAB; Ambien CR; Voltaren; Cytomel; Nexium; Meclizine; Lipitor; Amrix; Depo-Testosterone



Possible Prialt side effects in 44 year old male

Reported by a pharmacist from United States on 2012-03-06

Patient: 44 year old male

Reactions: Screaming, Crying, Aggression

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prialt

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2012