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Fentora Adverse Events Reported to the FDA Over Time

How are Fentora adverse event reports trending over time?

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

Most Common Fentora Adverse Events Reported to the FDA

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

Wrong Technique In Drug Usage Proce...
4375 (4.43%)
Drug Ineffective
2481 (2.51%)
Product Quality Issue
2315 (2.34%)
Pain
1862 (1.88%)
Nausea
1510 (1.53%)
Overdose
1280 (1.29%)
Somnolence
1273 (1.29%)
Drug Prescribing Error
1261 (1.28%)
Inappropriate Schedule Of Drug Admi...
1208 (1.22%)
Vomiting
1163 (1.18%)
Hyperhidrosis
1034 (1.05%)
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Withdrawal Syndrome
1028 (1.04%)
Drug Effect Decreased
934 (.94%)
Drug Administered At Inappropriate ...
917 (.93%)
Drug Withdrawal Syndrome
910 (.92%)
Inadequate Analgesia
902 (.91%)
Dizziness
897 (.91%)
Dyspnoea
860 (.87%)
Drug Toxicity
742 (.75%)
Feeling Abnormal
702 (.71%)
Loss Of Consciousness
700 (.71%)
Fall
667 (.67%)
Insomnia
667 (.67%)
Malaise
664 (.67%)
Confusional State
661 (.67%)
Death
634 (.64%)
Weight Decreased
619 (.63%)
Respiratory Arrest
615 (.62%)
Intentional Drug Misuse
592 (.6%)
Drug Interaction
580 (.59%)
Treatment Noncompliance
569 (.58%)
Headache
560 (.57%)
Cardiac Arrest
548 (.55%)
Back Pain
539 (.55%)
Fatigue
539 (.55%)
Constipation
533 (.54%)
Application Site Erythema
519 (.52%)
Drug Dose Omission
519 (.52%)
Hypotension
513 (.52%)
Tremor
511 (.52%)
Application Site Pruritus
494 (.5%)
Incorrect Drug Administration Durat...
492 (.5%)
Anxiety
468 (.47%)
Convulsion
456 (.46%)
Hypertension
445 (.45%)
Application Site Rash
443 (.45%)
Therapeutic Response Decreased
421 (.43%)
Asthenia
408 (.41%)
Depression
408 (.41%)
Medication Error
387 (.39%)
Cardio-respiratory Arrest
382 (.39%)
Completed Suicide
370 (.37%)
Unresponsive To Stimuli
370 (.37%)
Incorrect Dose Administered
366 (.37%)
Respiratory Depression
366 (.37%)
Drug Administration Error
364 (.37%)
Pneumonia
354 (.36%)
Delirium
348 (.35%)
Muscle Spasms
342 (.35%)
Drug Effect Increased
329 (.33%)
Diarrhoea
328 (.33%)
Depressed Level Of Consciousness
327 (.33%)
Chest Pain
312 (.32%)
Application Site Irritation
311 (.31%)
Hallucination
311 (.31%)
Pruritus
300 (.3%)
Pyrexia
299 (.3%)
Dehydration
290 (.29%)
Agitation
284 (.29%)
Coma
282 (.29%)
Oxygen Saturation Decreased
277 (.28%)
Condition Aggravated
274 (.28%)
Pain In Extremity
273 (.28%)
Abdominal Pain
266 (.27%)
Decreased Appetite
266 (.27%)
Drug Abuse
264 (.27%)
Amnesia
262 (.27%)
Chills
258 (.26%)
Rash
252 (.25%)
Serotonin Syndrome
252 (.25%)
Incorrect Route Of Drug Administrat...
250 (.25%)
Oedema Peripheral
247 (.25%)
Accidental Overdose
245 (.25%)
Lethargy
243 (.25%)
Sedation
243 (.25%)
Gait Disturbance
240 (.24%)
Disorientation
227 (.23%)
Weight Increased
227 (.23%)
Tachycardia
222 (.22%)
Application Site Pain
221 (.22%)
Arthralgia
221 (.22%)
Blood Pressure Decreased
221 (.22%)
Bradycardia
221 (.22%)
Application Site Reaction
220 (.22%)
Device Leakage
214 (.22%)
Narcotic Intoxication
214 (.22%)
Heart Rate Increased
211 (.21%)
Blood Pressure Increased
209 (.21%)
Off Label Use
206 (.21%)
Nervousness
200 (.2%)
Application Site Vesicles
199 (.2%)

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

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

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

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

Pain
6843
Back Pain
3142
Drug Use For Unknown Indication
2480
Product Used For Unknown Indication
2350
Cancer Pain
1284
Anaesthesia
771
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Fibromyalgia
577
Arthralgia
499
Induction Of Anaesthesia
449
Pain In Extremity
431
Neck Pain
385
General Anaesthesia
355
Sedation
342
Analgesic Therapy
302
Arthritis
279
Neuropathy Peripheral
222
Breakthrough Pain
211
Pain Management
210
Neuralgia
203
Abdominal Pain
195
Rheumatoid Arthritis
185
Intervertebral Disc Degeneration
178
Procedural Pain
173
Osteoarthritis
169
Migraine
152
Bone Pain
147
Intervertebral Disc Protrusion
147
Musculoskeletal Pain
142
Complex Regional Pain Syndrome
137
Ill-defined Disorder
131
Spinal Column Stenosis
120
Surgery
118
Headache
116
Analgesia
104
Maintenance Of Anaesthesia
99
Epidural Anaesthesia
89
Analgesic Effect
86
Intentional Drug Misuse
84
Anaesthesia Procedure
83
Sedative Therapy
80
Osteoporosis
76
Systemic Lupus Erythematosus
70
Spinal Anaesthesia
68
Sciatica
68
Back Disorder
67
Postoperative Analgesia
65
Multiple Sclerosis
58
Abdominal Pain Upper
55
Drug Abuse
53
Multiple Myeloma
52
Crohns Disease
50

Drug Labels

LabelLabelerEffective
FentoraCephalon, Inc.21-FEB-13

Fentora Case Reports

What Fentora 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 Fentora. 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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