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FENTANYL CITRATE

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Fentanyl Citrate Adverse Events Reported to the FDA Over Time

How are Fentanyl Citrate adverse event reports trending over time?

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

Most Common Fentanyl Citrate Adverse Events Reported to the FDA

What are the most common Fentanyl Citrate adverse events reported to the FDA?

Wrong Technique In Drug Usage Proce...
9721 (5.32%)
Product Quality Issue
5240 (2.87%)
Drug Ineffective
4677 (2.56%)
Pain
3586 (1.96%)
Inappropriate Schedule Of Drug Admi...
3184 (1.74%)
Nausea
2897 (1.59%)
Vomiting
2309 (1.26%)
Withdrawal Syndrome
2219 (1.21%)
Overdose
2211 (1.21%)
Somnolence
2184 (1.2%)
Hyperhidrosis
2140 (1.17%)
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Drug Administered At Inappropriate ...
1944 (1.06%)
Drug Prescribing Error
1879 (1.03%)
Dizziness
1674 (.92%)
Drug Effect Decreased
1593 (.87%)
Dyspnoea
1549 (.85%)
Inadequate Analgesia
1520 (.83%)
Fall
1388 (.76%)
Death
1360 (.74%)
Feeling Abnormal
1359 (.74%)
Drug Withdrawal Syndrome
1318 (.72%)
Malaise
1316 (.72%)
Insomnia
1303 (.71%)
Drug Toxicity
1283 (.7%)
Drug Dose Omission
1276 (.7%)
Confusional State
1251 (.68%)
Weight Decreased
1227 (.67%)
Incorrect Drug Administration Durat...
1178 (.64%)
Headache
1176 (.64%)
Loss Of Consciousness
1166 (.64%)
Treatment Noncompliance
1120 (.61%)
Depression
1080 (.59%)
Therapeutic Response Decreased
1076 (.59%)
Anxiety
1036 (.57%)
Constipation
998 (.55%)
Back Pain
992 (.54%)
Fatigue
982 (.54%)
Tremor
915 (.5%)
Hypertension
903 (.49%)
Drug Interaction
896 (.49%)
Application Site Erythema
894 (.49%)
Intentional Drug Misuse
838 (.46%)
Application Site Pruritus
837 (.46%)
Medication Error
819 (.45%)
Application Site Rash
807 (.44%)
Asthenia
805 (.44%)
Convulsion
778 (.43%)
Respiratory Arrest
744 (.41%)
Pneumonia
723 (.4%)
Hypotension
720 (.39%)
Drug Administration Error
714 (.39%)
Muscle Spasms
676 (.37%)
Cardiac Arrest
646 (.35%)
Coma
646 (.35%)
Diarrhoea
637 (.35%)
Incorrect Dose Administered
631 (.35%)
Respiratory Depression
626 (.34%)
Pain In Extremity
603 (.33%)
Pruritus
592 (.32%)
Breakthrough Pain
585 (.32%)
Application Site Irritation
579 (.32%)
Chest Pain
579 (.32%)
Pyrexia
563 (.31%)
Hallucination
556 (.3%)
Dehydration
545 (.3%)
Application Site Reaction
527 (.29%)
Amnesia
495 (.27%)
Depressed Level Of Consciousness
473 (.26%)
Weight Increased
469 (.26%)
Agitation
467 (.26%)
Drug Effect Increased
463 (.25%)
Cardio-respiratory Arrest
456 (.25%)
Delirium
456 (.25%)
Oedema Peripheral
456 (.25%)
Disorientation
450 (.25%)
Rash
444 (.24%)
Unresponsive To Stimuli
444 (.24%)
Off Label Use
434 (.24%)
Abdominal Pain
432 (.24%)
Arthralgia
431 (.24%)
Dermatitis Contact
431 (.24%)
Chills
427 (.23%)
Completed Suicide
426 (.23%)
Decreased Appetite
425 (.23%)
Sedation
422 (.23%)
Lethargy
413 (.23%)
Blood Pressure Increased
409 (.22%)
Cerebrovascular Accident
405 (.22%)
Accidental Overdose
400 (.22%)
Hospitalisation
399 (.22%)
Device Leakage
397 (.22%)
Condition Aggravated
395 (.22%)
Myocardial Infarction
395 (.22%)
Hypersomnia
382 (.21%)
Gait Disturbance
377 (.21%)
Suicidal Ideation
376 (.21%)
Road Traffic Accident
368 (.2%)
Nervousness
364 (.2%)
Narcotic Intoxication
361 (.2%)
Blood Cholesterol Increased
357 (.2%)
Drug Abuse
356 (.19%)

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

What are the most common Fentanyl Citrate adverse events reported to the FDA?

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

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

Pain
13515
Back Pain
5355
Drug Use For Unknown Indication
4630
Product Used For Unknown Indication
3704
Cancer Pain
2169
Fibromyalgia
970
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Arthralgia
836
Anaesthesia
774
Pain Management
650
Pain In Extremity
637
Neck Pain
593
Induction Of Anaesthesia
450
Analgesic Therapy
416
Arthritis
416
Neuralgia
363
General Anaesthesia
355
Sedation
342
Bone Pain
328
Neuropathy Peripheral
324
Osteoarthritis
305
Intervertebral Disc Degeneration
301
Rheumatoid Arthritis
290
Abdominal Pain
276
Ill-defined Disorder
273
Intervertebral Disc Protrusion
267
Procedural Pain
256
Musculoskeletal Pain
246
Breakthrough Pain
228
Migraine
217
Complex Regional Pain Syndrome
202
Headache
195
Spinal Column Stenosis
183
Surgery
148
Intentional Misuse
141
Analgesia
140
Intentional Drug Misuse
136
Sciatica
126
Analgesic Effect
122
Back Disorder
116
Osteoporosis
114
Systemic Lupus Erythematosus
110
Maintenance Of Anaesthesia
99
Nerve Injury
94
Abdominal Pain Upper
90
Epidural Anaesthesia
89
Multiple Sclerosis
88
Anaesthesia Procedure
83
Intervertebral Disc Disorder
81
Sedative Therapy
80
Radicular Pain
78
Postoperative Analgesia
73

Drug Labels

LabelLabelerEffective
Fentanyl CitrateBaxter Healthcare Corporation15-JUL-10
Fentanyl CitratePhysicians Total Care, Inc.17-MAR-11
Transmucosal Fentanyl CitrateH.J. Harkins Company, Inc.06-SEP-11
Fentanyl CitrateWest-ward Pharmaceutical Corp.09-DEC-11
Fentanyl CitrateCIMA Laboratories, Inc.28-DEC-11
ActiqCephalon, Inc.28-DEC-11
Fentanyl CitrateHospira, Inc.25-JAN-12
Fentanyl CitrateMallinckrodt Inc.23-FEB-12
Fentanyl CitratePar Pharmaceutical Inc.24-FEB-12
Fentanyl Citrate, Bupivacaine HclCantrell Drug Company16-AUG-12
Fentanyl CitrateCantrell Drug Company29-AUG-12
Fentanyl CitrateCantrell Drug Company06-SEP-12
Fentanyl Citrate, Bupivacaine HclCantrell Drug Company02-OCT-12
Fentanyl Citrate, Bupivacaine HclCantrell Drug Company02-OCT-12
Fentanyl CitrateCantrell Drug Company09-OCT-12
Fentanyl CitrateCantrell Drug Company09-OCT-12
Fentanyl CitrateCantrell Drug Company19-OCT-12
Fentanyl CitrateCantrell Drug Company29-OCT-12
Fentanyl CitrateCantrell Drug Company18-NOV-12
Fentanyl CitrateCantrell Drug Company18-NOV-12
Fentanyl CitrateTeva Pharmaceuticals USA Inc27-DEC-12
Fentanyl CitrateCantrell Drug Company27-DEC-12
Fentanyl CitrateCantrell Drug Company09-JAN-13
Fentanyl CitrateCantrell Drug Company30-JAN-13
Fentanyl CitrateCantrell Drug Company15-FEB-13
Fentanyl CitrateHospira, Inc.26-FEB-13
Fentanyl CitrateCantrell Drug Company14-MAR-13
Fentanyl Citrate, Bupivacaine HclCantrell Drug Company25-MAR-13
Fentanyl CitrateCantrell Drug Company05-APR-13
Fentanyl CitrateCantrell Drug Company23-APR-13

Fentanyl Citrate Case Reports

What Fentanyl Citrate 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 Fentanyl Citrate. 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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