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Fentora Side Effects

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Common Fentora Side Effects


The most commonly reported Fentora side effects (click to view or check a box to report):

Pain (31)
Nausea (26)
Off Label Use (25)
Death (24)
Somnolence (23)
Vomiting (18)
Accidental Exposure (16)
Incorrect Dose Administered (16)
Stomatitis (13)
Tremor (12)
Application Site Irritation (12)
Dental Caries (12)
Accidental Overdose (11)
Overdose (11)
Dizziness (11)
Dysgeusia (10)
Malaise (9)
Unresponsive To Stimuli (9)
Product Quality Issue (8)
Diarrhoea (8)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Fentora Side Effects Reported to FDA



Fentora Side Effect Report#9980948
This is a report of a 57-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Fentora (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentora treatment in female patients, resulting in Death side effect.
Fentora Side Effect Report#9928012
This report suggests a potential Fentora Death side effect(s) that can have serious consequences. A 47-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Fentora (dosage: NA) starting NS. After starting Fentora the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Fentora demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Fentora Side Effect Report#9868262
Gun Shot Wound, Spinal Fracture, Spinal Cord Injury, Paralysis, Osteonecrosis, Thrombosis, Adverse Event, Osteoarthritis, Gastrointestinal Stoma Complication
This Gun Shot Wound problem was reported by a consumer or non-health professional from US. A 32-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breakthrough pain. On 201011 this consumer started treatment with Fentora (dosage: NA). The following drugs were being taken at the same time: NA. When using Fentora, the patient experienced the following unwanted symptoms/side effects: Gun Shot Wound, Spinal Fracture, Spinal Cord Injury, Paralysis, Osteonecrosis, Thrombosis, Adverse Event, Osteoarthritis, Gastrointestinal Stoma ComplicationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gun Shot Wound, may become evident only after a product is in use by the general population.
Fentora Side Effect Report#9853710
Central Nervous System Lesion, Hepatic Encephalopathy, Malaise, Hepatic Failure
This Central Nervous System Lesion side effect was reported by a health professional from US. A 47-year-old female patient (weight:NA) experienced the following symptoms/conditions: breakthrough pain.The patient was prescribed Fentora (drug dosage: NA), which was initiated on
Sep 04, 2013. Concurrently used drugs:
  • Ms Contin
  • Hydrocodone
  • Lorazepam
  • Lomotil
  • Remeron
.After starting to take Fentora the consumer reported adverse symptoms, such as: Central Nervous System Lesion, Hepatic Encephalopathy, Malaise, Hepatic FailureThese side effects may potentially be related to Fentora. The patient was hospitalized.
Fentora Side Effect Report#9851111
Respiratory Failure, Encephalopathy
This is a report of a 61-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: breakthrough pain, who was treated with Fentora (dosage: NA, start time: NS), combined with:
  • Oxycontin (20 Milligram Daily;)
  • Oxycodone
  • Lorazepam
  • Lorazepam
  • Levothyroxine (100 Microgram Daily;)
  • Vitamin D3
  • Flonase
  • Triamcinolone
and developed a serious reaction and side effect(s): Respiratory Failure, Encephalopathy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentora treatment in female patients, resulting in Respiratory Failure side effect. The patient was hospitalized.
Fentora Side Effect Report#9842957
Breast Cancer Metastatic, Bone Cancer, Fracture, Femur Fracture, Mass, Investigation, Osteoarthritis, Fall
This report suggests a potential Fentora Breast Cancer Metastatic side effect(s) that can have serious consequences. A 45-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: metastatic pain and used Fentora (dosage: NA) starting
Sep 26, 2012. After starting Fentora the patient began experiencing various side effects, including: Breast Cancer Metastatic, Bone Cancer, Fracture, Femur Fracture, Mass, Investigation, Osteoarthritis, FallAdditional drugs used concurrently:
  • Oxycontin (240 Milligram Daily;)
  • Synthroid
  • Synthroid
  • Robaxin
  • Dilaudid
  • Lasix
The patient was hospitalized. Although Fentora demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Breast Cancer Metastatic, may still occur.
Fentora Side Effect Report#9814404
Dental Caries, Toothache, Tooth Fracture, Off Label Use
This Dental Caries problem was reported by a consumer or non-health professional from US. A 23-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: breakthrough pain. On 201202 this consumer started treatment with Fentora (dosage: NA). The following drugs were being taken at the same time: NA. When using Fentora, the patient experienced the following unwanted symptoms/side effects: Dental Caries, Toothache, Tooth Fracture, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dental Caries, may become evident only after a product is in use by the general population.
Fentora Side Effect Report#9807827
Lung Neoplasm Malignant, Sepsis
This Death side effect was reported by a consumer or non-health professional from US. A 67-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fentora (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fentora the consumer reported adverse symptoms, such as: Lung Neoplasm Malignant, SepsisThese side effects may potentially be related to Fentora. The patient was hospitalized.
Fentora Side Effect Report#9804475
Chemical Burn Of Gastrointestinal Tract, Stomatitis, Malaise, Off Label Use, Product Physical Issue
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Fentora (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Chemical Burn Of Gastrointestinal Tract, Stomatitis, Malaise, Off Label Use, Product Physical Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentora treatment in female patients, resulting in Chemical Burn Of Gastrointestinal Tract side effect.
Fentora Side Effect Report#9783098
Malaise, Pain, Gait Disturbance
This report suggests a potential Fentora Malaise side effect(s) that can have serious consequences. A male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: breakthrough pain and used Fentora (dosage: NA) starting 201206. After starting Fentora the patient began experiencing various side effects, including: Malaise, Pain, Gait DisturbanceAdditional drugs used concurrently:
  • Fentanyl
  • Lipitor
  • Xanax
  • Tricor
  • Aloxi
  • Coumadin
  • Glyburide
Although Fentora demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malaise, may still occur.
Fentora Side Effect Report#9708919
This Death problem was reported by a consumer or non-health professional from US. A 64-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Fentora (dosage: NA). The following drugs were being taken at the same time: NA. When using Fentora, the patient experienced the following unwanted symptoms/side effects:Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Fentora Side Effect Report#9699794
Back Pain, Mobility Decreased, Fatigue, Off Label Use
This Back Pain side effect was reported by a consumer or non-health professional from US. A 40-year-old male patient (weight:NA) experienced the following symptoms/conditions: back pain,hypertension,immunosuppression.The patient was prescribed Fentora (drug dosage: NA), which was initiated on 2009. Concurrently used drugs:
  • Atacand
  • Cyclosporine
  • Myfortic
  • Coreg
  • Dronabinol
  • Clonidine
  • Testosterone
  • Fentanyl
.After starting to take Fentora the consumer reported adverse symptoms, such as: Back Pain, Mobility Decreased, Fatigue, Off Label UseThese side effects may potentially be related to Fentora.
Fentora Side Effect Report#9678337
Adverse Event, Investigation
This is a report of a 41-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: breakthrough pain, who was treated with Fentora (dosage: NA, start time: NS), combined with:
  • Fentanyl (100 Mcg)
  • Roxanol
and developed a serious reaction and side effect(s): Adverse Event, Investigation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentora treatment in female patients, resulting in Death side effect. The patient was hospitalized.
Fentora Side Effect Report#9655942
Pain, Off Label Use
This report suggests a potential Fentora Pain side effect(s) that can have serious consequences. A 38-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Fentora (dosage: NA) starting NS. After starting Fentora the patient began experiencing various side effects, including: Pain, Off Label UseAdditional drugs used concurrently: NA. Although Fentora demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain, may still occur.
Fentora Side Effect Report#9649150
Pain, Off Label Use, Fall, Movement Disorder, Impaired Work Ability
This Pain problem was reported by a consumer or non-health professional from US. A 35-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On 201212 this consumer started treatment with Fentora (dosage: 200 And 400 Mcg). The following drugs were being taken at the same time: NA. When using Fentora, the patient experienced the following unwanted symptoms/side effects: Pain, Off Label Use, Fall, Movement Disorder, Impaired Work AbilityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pain, may become evident only after a product is in use by the general population.
Fentora Side Effect Report#9643418
Spinal Cord Disorder, Spinal Column Stenosis, Sciatica, Off Label Use, Blood Glucose Abnormal
This Spinal Cord Disorder side effect was reported by a consumer or non-health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: breakthrough pain.The patient was prescribed Fentora (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Actiq
  • Fentanyl
.After starting to take Fentora the consumer reported adverse symptoms, such as: Spinal Cord Disorder, Spinal Column Stenosis, Sciatica, Off Label Use, Blood Glucose AbnormalThese side effects may potentially be related to Fentora.
Fentora Side Effect Report#9606949
Adverse Event
This is a report of a 67-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Fentora (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Adverse Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentora treatment in female patients, resulting in Death side effect.
Fentora Side Effect Report#9587411
This report suggests a potential Fentora Death side effect(s) that can have serious consequences. A 49-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Fentora (dosage: NA) starting NS. After starting Fentora the patient began experiencing various side effects, including:Additional drugs used concurrently: NA. Although Fentora demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Death, may still occur.
Fentora Side Effect Report#9565807
Therapeutic Response Unexpected, Off Label Use
This Therapeutic Response Unexpected problem was reported by a consumer or non-health professional from US. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On 201307 this consumer started treatment with Fentora (dosage: NA). The following drugs were being taken at the same time:
  • Percocet
  • Exalgo
  • Ambien
When using Fentora, the patient experienced the following unwanted symptoms/side effects: Therapeutic Response Unexpected, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Therapeutic Response Unexpected, may become evident only after a product is in use by the general population.
Fentora Side Effect Report#9565300
Oophorectomy
This Oophorectomy side effect was reported by a pharmacist from US. A 39-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fentora (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fentora the consumer reported adverse symptoms, such as: OophorectomyThese side effects may potentially be related to Fentora.
Fentora Side Effect Report#9529783
Somnolence, Pain
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: breakthrough pain, who was treated with Fentora (dosage: NA, start time: NS), combined with:
  • Oxycontin
  • Cymbalta
and developed a serious reaction and side effect(s): Somnolence, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentora treatment in male patients, resulting in Somnolence side effect.
Fentora Side Effect Report#9492404
Electrolyte Imbalance, Malaise, Pain, Nausea, Product Quality Issue, Adverse Event
This report suggests a potential Fentora Electrolyte Imbalance side effect(s) that can have serious consequences. A 47-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Fentora (dosage: NA) starting 201307. After starting Fentora the patient began experiencing various side effects, including: Electrolyte Imbalance, Malaise, Pain, Nausea, Product Quality Issue, Adverse EventAdditional drugs used concurrently:
  • Actiq
  • Fentanyl (37.5 Microgram Daily;)
  • Prilosec
  • Wellbutrin
  • Hydrochlorothiazide
  • Seroquel (At Bedtime)
  • Zofran (16 Milligram Daily;)
The patient was hospitalized. Although Fentora demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Electrolyte Imbalance, may still occur.
Fentora Side Effect Report#9401154
Pancreatic Carcinoma
This Pancreatic Carcinoma problem was reported by a consumer or non-health professional from US. A 52-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: breakthrough pain. On NS this consumer started treatment with Fentora (dosage: NA). The following drugs were being taken at the same time: NA. When using Fentora, the patient experienced the following unwanted symptoms/side effects: Pancreatic CarcinomaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pancreatic Carcinoma, may become evident only after a product is in use by the general population.
Fentora Side Effect Report#9398860
Pain, Off Label Use
This Pain side effect was reported by a consumer or non-health professional from US. A female patient (weight:NA) experienced the following symptoms/conditions: trigeminal neuralgia,pain.The patient was prescribed Fentora (drug dosage: NA), which was initiated on 2010. Concurrently used drugs:
  • Avinza
  • Vicodin
  • Wellbutrin
  • Seroquel
  • Savella
.After starting to take Fentora the consumer reported adverse symptoms, such as: Pain, Off Label UseThese side effects may potentially be related to Fentora.
Fentora Side Effect Report#9382848
Confusional State
This is a report of a 66-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: squamous cell carcinoma, who was treated with Fentora (dosage: NA, start time:
Mar 20, 2013), combined with:
  • Coumadin
  • Ultram
  • Tessalon Pearls
  • Carbitaxel
  • Paxitaxel
  • Fentanyl Patch
  • Decadron
  • Zofran
and developed a serious reaction and side effect(s): Confusional State after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentora treatment in female patients, resulting in Death side effect.


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The appearance of Fentora on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Fentora Side Effects for Women?

Women Side EffectsReports
Pain 21
Nausea 18
Off Label Use 18
Death 17
Accidental Exposure 14
Somnolence 14
Dizziness 10
Stomatitis 10
Vomiting 10
Dental Caries 9

What are common Fentora Side Effects for Men?

Men Side EffectsReports
Pain 10
Somnolence 9
Nausea 8
Vomiting 8
Death 7
Incorrect Dose Administered 7
Off Label Use 7
Condition Aggravated 6
Abdominal Pain 5
Application Site Irritation 5

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Fentora reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Fentora Side Effects

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    How Effective is Fentora for You?

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    Fentora Safety Alerts, Active Ingredients, Usage Information

    Fentora Dosage, Warnings, Usage.

    Side Effects reported to FDA: 321

    Fentora safety alerts: 2007

    Reported deaths: 87

    Reported hospitalizations: 51

    Fentora (fentanyl buccal tablet)

    Audience: Pain management specialists, other healthcare professionals

    [UPDATED 09/26/2007] FDA issued a Public Health Advisory and a Healthcare Professional Sheet to alert healthcare professionals and consumers regarding concerns over the use of Fentora (fentanyl buccal) tablets after recent reports of deaths and other adverse events. The deaths reported were the result of improper selection of patients, dosing, or improper product substitution.

    FDA warned physicians and other healthcare professionals that it is critical to follow product labeling when administering Fentora. FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines. It is critical that Fentora not be used in patients who are not opioid tolerant.

    Patients also must be under a doctorâ??s care and close supervision while taking Fentora and the dose should be carefully adjusted to control breakthrough pain adequately.

    In addition, FDA is concerned about the improper substitution of Fentora, a quick acting pain drug, for other pain medicines. Fentora is not the same as other fentanyl products and cannot be substituted for Actiq, another fentanyl product used to treat breakthrough cancer pain. Because Fentora delivers more fentanyl to the blood than Actiq, substituting Fentora for Actiq using the same dose can result in a fatal overdose.

    [Posted 09/13/2007] Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora. Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Serious adverse events, including deaths, have occurred in patients treated with Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of Fentora to reduce the risk of respiratory depression.

    [September 26, 2007 - Public Health Advisory - FDA]
    [September 26, 2007 - Healthcare Information Sheet - FDA]
    [September 10, 2007 - Dear Doctor Letter - Cephalon]
    [September 10, 2007 - Dear Healthcare Professional Letter - Cephalon]
    [March 2007 - Label with Medication Guide - Cephalon]

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