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Prialt Adverse Events Reported to the FDA Over Time

How are Prialt adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Prialt, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Prialt is flagged as the suspect drug causing the adverse event.

Most Common Prialt Adverse Events Reported to the FDA

What are the most common Prialt adverse events reported to the FDA?

Pain
102 (3.01%)
Confusional State
93 (2.75%)
Dizziness
60 (1.77%)
Nausea
60 (1.77%)
Headache
51 (1.51%)
Psychotic Disorder
40 (1.18%)
Memory Impairment
39 (1.15%)
Oedema Peripheral
39 (1.15%)
Fall
36 (1.06%)
Hallucination
36 (1.06%)
Asthenia
34 (1%)
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Hallucination, Auditory
34 (1%)
Vomiting
34 (1%)
Insomnia
31 (.92%)
Muscle Spasms
31 (.92%)
Anxiety
30 (.89%)
Dysgeusia
30 (.89%)
Pain In Extremity
29 (.86%)
Somnolence
29 (.86%)
Depression
28 (.83%)
Burning Sensation
26 (.77%)
Condition Aggravated
26 (.77%)
Diarrhoea
25 (.74%)
Balance Disorder
23 (.68%)
Disorientation
23 (.68%)
Fatigue
23 (.68%)
Amnesia
22 (.65%)
Back Pain
22 (.65%)
Urinary Retention
22 (.65%)
Gait Disturbance
21 (.62%)
Pneumonia
21 (.62%)
Agitation
20 (.59%)
Blood Creatine Phosphokinase Increa...
20 (.59%)
Hypoaesthesia
20 (.59%)
Speech Disorder
20 (.59%)
Vision Blurred
20 (.59%)
Aphasia
19 (.56%)
Dyspnoea
19 (.56%)
Tremor
19 (.56%)
Decreased Appetite
18 (.53%)
Mental Impairment
18 (.53%)
Pyrexia
18 (.53%)
Urinary Tract Infection
18 (.53%)
Weight Decreased
18 (.53%)
Abnormal Behaviour
17 (.5%)
Aggression
17 (.5%)
Feeling Cold
17 (.5%)
Hyperhidrosis
17 (.5%)
Overdose
17 (.5%)
Arthralgia
16 (.47%)
Dehydration
16 (.47%)
Hallucination, Visual
16 (.47%)
Chills
15 (.44%)
Delirium
15 (.44%)
Drug Ineffective
15 (.44%)
Drug Withdrawal Syndrome
15 (.44%)
Feeling Abnormal
15 (.44%)
Mental Status Changes
15 (.44%)
Paraesthesia
15 (.44%)
Suicidal Ideation
15 (.44%)
Chest Pain
14 (.41%)
Disturbance In Attention
14 (.41%)
Respiratory Failure
14 (.41%)
Hypotension
13 (.38%)
Muscular Weakness
13 (.38%)
Myalgia
13 (.38%)
Paraesthesia Oral
13 (.38%)
Rhabdomyolysis
13 (.38%)
Anorexia
12 (.35%)
Catheter Related Complication
12 (.35%)
Loss Of Consciousness
12 (.35%)
Myocardial Infarction
12 (.35%)
Coordination Abnormal
11 (.32%)
Dry Mouth
11 (.32%)
Hyperaesthesia
11 (.32%)
Hypersomnia
11 (.32%)
Nervousness
11 (.32%)
Paranoia
11 (.32%)
Sensory Disturbance
11 (.32%)
Tinnitus
11 (.32%)
Vertigo
11 (.32%)
Anaemia
10 (.3%)
Coma
10 (.3%)
Lethargy
10 (.3%)
Malaise
10 (.3%)
Musculoskeletal Stiffness
10 (.3%)
Pruritus
10 (.3%)
Pulmonary Embolism
10 (.3%)
Abdominal Pain
9 (.27%)
Convulsion
9 (.27%)
Death
9 (.27%)
Dysarthria
9 (.27%)
Dysphagia
9 (.27%)
Faecal Incontinence
9 (.27%)
Mood Altered
9 (.27%)
Neck Pain
9 (.27%)
Rash
9 (.27%)
Road Traffic Accident
9 (.27%)
Suicide Attempt
9 (.27%)
Urinary Incontinence
9 (.27%)
Depressed Level Of Consciousness
8 (.24%)

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This graph shows the top adverse events submitted to the FDA for Prialt, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Prialt is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Prialt

What are the most common Prialt adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Prialt, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Prialt is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Prialt According to Those Reporting Adverse Events

Why are people taking Prialt, according to those reporting adverse events to the FDA?

Pain
249
Back Pain
74
Drug Use For Unknown Indication
55
Post Laminectomy Syndrome
42
Neuralgia
28
Complex Regional Pain Syndrome
26
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Cancer Pain
14
Neuropathy Peripheral
12
Pain In Extremity
12
Arachnoiditis
8
Spinal Cord Injury
6
Procedural Pain
5
Diabetic Neuropathy
4
Product Used For Unknown Indication
4
Intervertebral Disc Degeneration
4
Fibromyalgia
4
Myelitis
4
Surgery
3
Nerve Injury
3
Spinal Laminectomy
3
Pancreatitis
2
Metastatic Pain
2
Surgical Failure
2
Muscle Spasms
2
Neuropathy
2
Muscle Spasticity
2
Lumbar Radiculopathy
2
Bone Pain
2
Tumour Pain
2
Trigeminal Neuralgia
2
Radicular Pain
2
Syringomyelia
2
Post Procedural Pain
1
Inadequate Analgesia
1
Radiculopathy
1
Central Pain Syndrome
1
Breast Cancer Metastatic
1
Femoral Nerve Injury
1
Multiple Sclerosis
1
Spinal Fusion Acquired
1
Neck Pain
1
Spinal Compression Fracture
1
Joint Arthroplasty
1
Spinal Disorder
1
Coccydynia
1
Accidental Exposure
1
Pain Management
1
Arthropathy
1
Lung Neoplasm Malignant
1
Headache
1
Pelvic Pain
1

Drug Labels

LabelLabelerEffective
PrialtJazz Pharmaceuticals, Inc.31-JAN-13

Prialt Case Reports

What Prialt safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Prialt. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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