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Actiq Adverse Events Reported to the FDA Over Time

How are Actiq adverse event reports trending over time?

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

Most Common Actiq Adverse Events Reported to the FDA

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

Drug Prescribing Error
157 (3.4%)
Drug Dependence
149 (3.23%)
Accidental Drug Intake By Child
143 (3.1%)
Dental Caries
123 (2.66%)
Somnolence
106 (2.29%)
Off Label Use
97 (2.1%)
Pain
84 (1.82%)
Drug Withdrawal Syndrome
82 (1.77%)
Tooth Loss
82 (1.77%)
Overdose
81 (1.75%)
Vomiting
72 (1.56%)
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Death
61 (1.32%)
Nausea
59 (1.28%)
Drug Toxicity
53 (1.15%)
Depression
49 (1.06%)
Drug Ineffective
47 (1.02%)
Lethargy
46 (1%)
Convulsion
38 (.82%)
Tooth Disorder
37 (.8%)
Anxiety
34 (.74%)
Malaise
34 (.74%)
Intentional Drug Misuse
33 (.71%)
Dependence
32 (.69%)
Medication Error
32 (.69%)
Accidental Exposure
30 (.65%)
Loss Of Consciousness
29 (.63%)
Suicidal Ideation
28 (.61%)
Drug Abuse
27 (.58%)
Malignant Neoplasm Progression
27 (.58%)
Tooth Fracture
27 (.58%)
Accidental Overdose
26 (.56%)
Coma
26 (.56%)
Constipation
26 (.56%)
Fatigue
26 (.56%)
Insomnia
26 (.56%)
Weight Decreased
26 (.56%)
Withdrawal Syndrome
26 (.56%)
Headache
25 (.54%)
Hyperhidrosis
25 (.54%)
Dry Mouth
23 (.5%)
Dyspnoea
23 (.5%)
Incorrect Dose Administered
23 (.5%)
Suicide Attempt
23 (.5%)
Tremor
23 (.5%)
Fall
22 (.48%)
Diarrhoea
21 (.45%)
Dysarthria
21 (.45%)
Confusional State
20 (.43%)
Cardiac Arrest
19 (.41%)
Dizziness
19 (.41%)
Drug Abuser
18 (.39%)
Hypotension
18 (.39%)
Treatment Noncompliance
18 (.39%)
Amnesia
17 (.37%)
Respiratory Depression
17 (.37%)
Unevaluable Event
17 (.37%)
Tachycardia
16 (.35%)
Ataxia
15 (.32%)
Hallucination
15 (.32%)
Inappropriate Schedule Of Drug Admi...
15 (.32%)
Mental Status Changes
15 (.32%)
Dehydration
14 (.3%)
Multiple Drug Overdose Accidental
14 (.3%)
Neoplasm Malignant
14 (.3%)
Toothache
14 (.3%)
Abnormal Behaviour
13 (.28%)
Thinking Abnormal
13 (.28%)
Drug Effect Decreased
12 (.26%)
Memory Impairment
12 (.26%)
Mental Disorder Due To A General Me...
12 (.26%)
Oral Pain
12 (.26%)
Pyrexia
12 (.26%)
Screaming
12 (.26%)
Sedation
12 (.26%)
Substance Abuse
12 (.26%)
Tooth Abscess
12 (.26%)
Cardiac Disorder
11 (.24%)
Chills
11 (.24%)
Inadequate Analgesia
11 (.24%)
Pneumonia
11 (.24%)
Tooth Extraction
11 (.24%)
Vision Blurred
11 (.24%)
Asthenia
10 (.22%)
Deep Vein Thrombosis
10 (.22%)
Depressed Level Of Consciousness
10 (.22%)
Feeling Abnormal
10 (.22%)
Heart Rate Increased
10 (.22%)
Hypertension
10 (.22%)
Irritability
10 (.22%)
Miosis
10 (.22%)
Multiple Drug Overdose
10 (.22%)
Respiratory Failure
10 (.22%)
Abdominal Pain
9 (.19%)
Agitation
9 (.19%)
Completed Suicide
9 (.19%)
Crying
9 (.19%)
Drug Administration Error
9 (.19%)
Drug Tolerance
9 (.19%)
Gingival Erosion
9 (.19%)
Mental Disorder
9 (.19%)
Pulmonary Oedema
9 (.19%)

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This graph shows the top adverse events submitted to the FDA for Actiq, 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 Actiq 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 Actiq

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

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This graph shows the top categories of adverse events submitted to the FDA for Actiq, 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 Actiq 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 Actiq According to Those Reporting Adverse Events

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

Pain
272
Back Pain
147
Cancer Pain
98
Breakthrough Pain
68
Migraine
43
Drug Use For Unknown Indication
36
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Neck Pain
35
Fibromyalgia
32
Abdominal Pain
32
Arthralgia
24
Headache
21
Neuralgia
20
Pain In Extremity
19
Complex Regional Pain Syndrome
18
Product Used For Unknown Indication
12
Systemic Lupus Erythematosus
11
Proctalgia
10
Crohns Disease
10
Bone Pain
9
Pain Management
9
Arthropathy
7
Trigeminal Neuralgia
7
Rheumatoid Arthritis
7
Musculoskeletal Pain
7
Procedural Pain
6
Neoplasm Malignant
6
Arthritis
6
Neuropathy Peripheral
5
Intervertebral Disc Degeneration
5
Tumour Pain
5
Neuropathy
5
Ankylosing Spondylitis
5
Nerve Injury
5
Liver Carcinoma Ruptured
4
Spinal Cord Injury
4
Pelvic Pain
4
Sciatica
4
Abdominal Pain Upper
4
Analgesia
3
Facial Neuralgia
3
Osteoarthritis
3
Breast Cancer
3
Paraplegia
3
Post Laminectomy Syndrome
3
Intervertebral Disc Protrusion
3
Surgery
3
Paralysis
3
Osteoporosis
3
Cluster Headache
3
Muscular Dystrophy
3
Breast Cancer Metastatic
2

Drug Labels

LabelLabelerEffective
ActiqCephalon, Inc.28-DEC-11

Actiq Case Reports

What Actiq 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 Actiq. 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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