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Fentanyl (Fentanyl) - Product Quality Issue - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Product Quality Issue (194)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fentanyl where reactions include product quality issue. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 194   Next >>

Possible Fentanyl side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: male, weighing 90.7 kg (199.6 pounds)

Reactions: Drug Dose Omission, Wrong Technique in Drug Usage Process, Sciatica, Pain, Fall, Abdominal Discomfort, Malaise, Neuropathy Peripheral, Peroneal Nerve Palsy, Abnormal Loss of Weight, Formication, Muscle Spasms, Decreased Appetite, Inappropriate Schedule of Drug Administration, Back Pain, Product Quality Issue, Drug Effect Decreased, Vomiting, Nausea, Hypoaesthesia, Anxiety, Incorrect Drug Administration Duration

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Duragesic-100
    Indication: Pain
    Start date: 2009-01-01

Duragesic-100
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-01-01

Duragesic-100
    Start date: 2011-07-01
    End date: 2012-06-01

Duragesic-100
    Start date: 2012-06-01

Fentanyl
    Start date: 2010-01-01

Fentanyl
    Indication: Surgery
    Start date: 2008-09-01
    End date: 2008-10-01

Fentanyl
    Start date: 2008-10-01

Fentanyl Citrate
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-09-01

Fentanyl-100
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-09-01

Oxycodone HCL
    Administration route: Oral
    Indication: Breakthrough Pain
    Start date: 2009-01-01
    End date: 2010-01-01

Other drugs received by patient: Flexeril; Lyrica; Effexor; Clonazepam; Aleve; Effexor



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Product Quality Issue, Dermatitis Contact, Wrong Technique in Drug Usage Process, Hyperhidrosis, Drug Prescribing Error, Neoplasm

Drug(s) suspected as cause:
Duragesic-100
    Dosage: 2000/2001
    Indication: Complex Regional Pain Syndrome

Duragesic-100

Fentanyl
    Indication: Complex Regional Pain Syndrome



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female, weighing 61.2 kg (134.7 pounds)

Reactions: Product Quality Issue, Wrong Technique in Drug Usage Process

Drug(s) suspected as cause:
Fentanyl

Other drugs received by patient: Allegra; Proxicam; Oxycodone HCL; Levoxyl; Protonix



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: female, weighing 86.2 kg (189.6 pounds)

Reactions: Product Quality Issue, Wrong Technique in Drug Usage Process

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: female, weighing 86.2 kg (189.6 pounds)

Reactions: Wrong Technique in Drug Usage Process, Drug Ineffective, Paralysis, Fall, Arthropathy, Balance Disorder, Irritable Bowel Syndrome, Oesophageal Haemorrhage, Carpal Tunnel Syndrome, Transient Ischaemic Attack, Heart Rate Abnormal, Product Quality Issue, Amnesia, Cerebrovascular Accident, Blood Glucose Decreased, Application Site Urticaria, Oesophageal Disorder, Gait Disturbance

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Fentanyl

Fentanyl

Fentanyl
    Start date: 2007-01-01

Fentanyl
    Indication: Pain
    End date: 2011-02-01

Fentanyl

Fentanyl
    Start date: 2009-01-01

Fentanyl-100
    Dosage: ndc# 0781-7243-55
    Indication: Pain
    Start date: 2011-02-01

Other drugs received by patient: Methadone Hydrochloride; Soma; Methadone Hydrochloride; Oxycodone HCL and Acetaminophen



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: female

Reactions: Product Quality Issue, Inappropriate Schedule of Drug Administration, Pain, Hyperhidrosis

Drug(s) suspected as cause:
Fentanyl
    Dosage: 100 ug/hr and 50 ug/hr (ndc-0781-7242-55)
    Indication: Cancer Pain
    Start date: 2012-04-01

Fentanyl
    Dosage: 100 ug/hr and 25 ug/hr
    Start date: 2011-01-01
    End date: 2012-04-01

Sertraline Hydrochloride
    Administration route: Oral
    Indication: Neuropathy Peripheral
    End date: 2012-01-01

Other drugs received by patient: Omeprazole; Amlodipine; Senna Plus; Calcium; Lidoderm; Mutivitamins; Morphine Sulfate; Prednisone TAB; Folic Acid



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: female

Reactions: Product Quality Issue, Drug Ineffective, Poor Quality Drug Administered

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: male, weighing 90.7 kg (199.6 pounds)

Reactions: Product Quality Issue, Inappropriate Schedule of Drug Administration, Back Pain, Wrong Technique in Drug Usage Process, Pain, Sciatica, Hypoaesthesia, Fall, Abdominal Discomfort, Neuropathy Peripheral, Malaise, Peroneal Nerve Palsy, Formication, Muscle Spasms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Duragesic-100
    Start date: 2011-07-01
    End date: 2012-06-01

Duragesic-100
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-01

Fentanyl
    Indication: Surgery
    Start date: 2008-09-01
    End date: 2008-10-01

Fentanyl
    Start date: 2010-01-01

Fentanyl
    Start date: 2008-10-01

Fentanyl Citrate
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-09-01

Fentanyl-100
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-09-01

Oxycodone HCL
    Administration route: Oral
    Indication: Breakthrough Pain
    Start date: 2009-01-01
    End date: 2010-01-01

Other drugs received by patient: Effexor; Aleve; Flexeril; Effexor; Lyrica; Clonazepam



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Drug Administration Error, Inadequate Analgesia

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: male

Reactions: Product Quality Issue, Inadequate Analgesia

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in 66 year old female

Reported by a individual with unspecified qualification from United States on 2012-07-17

Patient: 66 year old female, weighing 52.2 kg (114.8 pounds)

Reactions: Product Substitution Issue, Product Quality Issue, Pruritus, Inadequate Analgesia, Product Adhesion Issue, Product Physical Issue, Erythema

Drug(s) suspected as cause:
Fentanyl
    Dosage: 100mcg/hr change every 48 hr transdermal
    Indication: Pain
    Start date: 2012-06-16
    End date: 2012-07-16

Fentanyl
    Dosage: 25mcg/hr change every 48 hr transdermal
    Indication: Pain
    Start date: 2012-06-16
    End date: 2012-07-16



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Hot Flush, Diarrhoea, Chills, Drug Administration Error, Rash, Hyperhidrosis, Abdominal Pain Upper

Drug(s) suspected as cause:
Fentanyl
    Dosage: 100 ug/hr
    Indication: Pain
    Start date: 2012-04-01

Fentanyl
    Dosage: 100 ug/hr
    Start date: 2012-04-01



Possible Fentanyl side effects in

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient:

Reactions: Product Quality Issue, Application Site Erosion

Drug(s) suspected as cause:
Fentanyl

Other drugs received by patient: Effexor; Amlodipine; Lopressor; Tricor; Metformin Hydrochloride; Lamictal



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Inadequate Analgesia

Drug(s) suspected as cause:
Fentanyl
    Dosage: 25 ug/hr, unk
    Indication: Migraine

Fentanyl
    Indication: Neck Injury

Fentanyl
    Dosage: 25 ug/hr one patch every 48 hours
    Indication: Pain
    Start date: 2012-03-01

Other drugs received by patient: Cyclobenazprine; Rythmol; Vitamin E / 00110501 /; Atenolol



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Drug Administration Error, Drug Withdrawal Syndrome

Drug(s) suspected as cause:
Fentanyl

Other drugs received by patient: Lyrica; Atacand; Mobic; Cymbalta; Lipitor



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Drug Administration Error, Inadequate Analgesia

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in female

Reported by a pharmacist from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Application Site Rash

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Drug Administration Error

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: male

Reactions: Product Quality Issue, Inadequate Analgesia, Drug Administration Error

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Drug Administration Error

Drug(s) suspected as cause:
Fentanyl

Other drugs received by patient: Oxycodone HCL



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Drug Administration Error

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in female

Reported by a pharmacist from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Application Site Erythema, Application Site Irritation

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: male, weighing 113.4 kg (249.4 pounds)

Reactions: Product Quality Issue, Dysgeusia, Inadequate Analgesia

Drug(s) suspected as cause:
Fentanyl

Other drugs received by patient: Elevil; Soma



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Nausea, Pain, Inadequate Analgesia, Drug Withdrawal Syndrome

Drug(s) suspected as cause:
Fentanyl

Other drugs received by patient: Morphine



Possible Fentanyl side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: male

Reactions: Product Quality Issue, Drug Administration Error

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient:

Reactions: Product Quality Issue, Drug Administration Error

Drug(s) suspected as cause:
Fentanyl



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Inadequate Analgesia, Hyperhidrosis

Drug(s) suspected as cause:
Fentanyl

Other drugs received by patient: Analgesia



Possible Fentanyl side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Drug Administration Error, Inadequate Analgesia

Drug(s) suspected as cause:
Fentanyl

Other drugs received by patient: Oxycodone HCL; Lyrica; Muscle Relaxer



Possible Fentanyl side effects in female

Reported by a pharmacist from United States on 2012-07-17

Patient: female

Reactions: Product Quality Issue, Inadequate Analgesia, Tremor

Drug(s) suspected as cause:
Fentanyl

Other drugs received by patient: Hydrocodone; Citalopram Hydrobromide



Possible Fentanyl side effects in

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient:

Reactions: Irritability, Product Quality Issue, Musculoskeletal Stiffness, Drug Withdrawal Syndrome, Cold Sweat, Tremor

Drug(s) suspected as cause:
Fentanyl



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