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Fentanyl Side Effects

PatientsVille

Common Fentanyl Side Effects


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

Pain (853)
Product Quality Issue (775)
Nausea (616)
Overdose (562)
Hyperhidrosis (453)
Vomiting (451)
Somnolence (436)
Product Adhesion Issue (418)
Death (415)
Dizziness (405)
Dyspnoea (382)
Inadequate Analgesia (345)
Loss Of Consciousness (306)
Withdrawal Syndrome (294)
Feeling Abnormal (288)
Application Site Erythema (277)
Toxicity To Various Agents (274)
Fall (273)
Confusional State (259)
Insomnia (257)

➢ 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.

Fentanyl Side Effects Reported to FDA



Fentanyl Side Effect Report#9999246
Myoclonus, Product Substitution Issue
This is a report of a 46-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain management, who was treated with Fentanyl Transdermal Patch 75 Mcg/h Watson (dosage: One Patch?one Patch Every 72?applied As Medicated Patch To Skin, start time:
Feb 01, 2014), combined with: NA. and developed a serious reaction and side effect(s): Myoclonus, Product Substitution Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentanyl Transdermal Patch 75 Mcg/h Watson treatment in female patients, resulting in Myoclonus side effect.
Fentanyl Side Effect Report#9993567
Pain
This report suggests a potential Fentanyl Pain side effect(s) that can have serious consequences. A 59-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Fentanyl (dosage: NA) starting NS. After starting Fentanyl the patient began experiencing various side effects, including: PainAdditional drugs used concurrently: NA. Although Fentanyl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain, may still occur.
Fentanyl Side Effect Report#9983331
Overdose, Gait Disturbance, Confusional State, Hypersomnia
This Overdose problem was reported by a consumer or non-health professional from US. A 56-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On
Feb 20, 2014 this consumer started treatment with Fentanyl Transdermal System (dosage: Changes Q 72hr). The following drugs were being taken at the same time: NA. When using Fentanyl Transdermal System, the patient experienced the following unwanted symptoms/side effects: Overdose, Gait Disturbance, Confusional State, HypersomniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Overdose, may become evident only after a product is in use by the general population.
Fentanyl Side Effect Report#9981353
Overdose
This Overdose side effect was reported by a health professional from US. A 20-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fentanyl Citrate (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fentanyl Citrate the consumer reported adverse symptoms, such as: OverdoseThese side effects may potentially be related to Fentanyl Citrate.
Fentanyl Side Effect Report#9981352
Overdose
This is a report of a 19-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Fentanyl Citrate (dosage: Unk, start time: NS), combined with:
  • Ethanol (Unk)
  • Diazepam (Unk)
  • Marijuana (Unk)
and developed a serious reaction and side effect(s): Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentanyl Citrate treatment in female patients, resulting in Overdose side effect.
Fentanyl Side Effect Report#9981350
Overdose
This report suggests a potential Fentanyl Citrate Overdose side effect(s) that can have serious consequences. A 46-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Fentanyl Citrate (dosage: Unk) starting NS. After starting Fentanyl Citrate the patient began experiencing various side effects, including: OverdoseAdditional drugs used concurrently:
  • Diazepam (Unk)
  • Hydrocodone (Unk)
Although Fentanyl Citrate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Overdose, may still occur.
Fentanyl Side Effect Report#9976057
Parotitis, Parotid Gland Enlargement
This Parotitis problem was reported by a health professional from BR. A 30-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Fentanyl (dosage: 100 Ug, Unk). The following drugs were being taken at the same time:
  • Lidocaine (10 Ml, Unk)
  • Lidocaine (10 Ml, Unk)
  • Cefazolin (2 G, Unk)
  • Dimenhydrinate (30 Mg, Unk)
  • Tenoxicam (40 Mg, Unk)
When using Fentanyl, the patient experienced the following unwanted symptoms/side effects: Parotitis, Parotid Gland EnlargementThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Parotitis, may become evident only after a product is in use by the general population.
Fentanyl Side Effect Report#9975877
Overdose
This Overdose side effect was reported by a health professional from US. A 49-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fentanyl Citrate (drug dosage: Unk), which was initiated on NS. Concurrently used drugs:
  • Morphine (Unk)
  • Roxicodone (Unk)
  • Ethanol (Unk)
  • Trazodone (Unk)
.After starting to take Fentanyl Citrate the consumer reported adverse symptoms, such as: OverdoseThese side effects may potentially be related to Fentanyl Citrate.
Fentanyl Side Effect Report#9975875
Overdose
This is a report of a 56-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Fentanyl Citrate (dosage: Unk, start time: NS), combined with:
  • Methadose (Unk)
  • Ethanol (Unk)
and developed a serious reaction and side effect(s): Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentanyl Citrate treatment in male patients, resulting in Overdose side effect.
Fentanyl Side Effect Report#9975865
Overdose
This report suggests a potential Fentanyl Citrate Overdose side effect(s) that can have serious consequences. A 55-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Fentanyl Citrate (dosage: Unk) starting NS. After starting Fentanyl Citrate the patient began experiencing various side effects, including: OverdoseAdditional drugs used concurrently:
  • Roxicodone (Unk)
  • Methamphetamine (Unk)
  • Amphetamine (Unk)
Although Fentanyl Citrate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Overdose, may still occur.
Fentanyl Side Effect Report#9972928
Anxiety, Sensation Of Foreign Body, Insomnia
This Anxiety problem was reported by a consumer or non-health professional from US. A 88-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On 201312 this consumer started treatment with Fentanyl-50 (watson Laboratories) (dosage: 1 Df, Every 3 Days). The following drugs were being taken at the same time: NA. When using Fentanyl-50 (watson Laboratories), the patient experienced the following unwanted symptoms/side effects: Anxiety, Sensation Of Foreign Body, InsomniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anxiety, may become evident only after a product is in use by the general population.
Fentanyl Side Effect Report#9958685
Respiratory Arrest
This Respiratory Arrest side effect was reported by a health professional from US. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: dental implantation.The patient was prescribed Fentanyl (drug dosage: NA), which was initiated on
Jan 31, 2014. Concurrently used drugs:
  • Midazolam
  • Ketamine
  • Penicillin (penicillin)
  • Propofol (propofol)
  • Decadron (decadron)
  • Lidocaine With Epinephrine
  • Marcaine With Epinephrine
.After starting to take Fentanyl the consumer reported adverse symptoms, such as: Respiratory ArrestThese side effects may potentially be related to Fentanyl.
Fentanyl Side Effect Report#9938076
Necrotising Fasciitis
This is a report of a 26-year-old female patient (weight: NA) from AU, suffering from the following health symptoms/conditions: NA, who was treated with Fentanyl (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Necrotising Fasciitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentanyl treatment in female patients, resulting in Necrotising Fasciitis side effect.
Fentanyl Side Effect Report#9931714
Delirium, Personality Disorder, Cognitive Disorder, Hyperaesthesia, Abdominal Pain, Anxiety
This report suggests a potential Fentanyl Tts Delirium side effect(s) that can have serious consequences. A 60-year-old male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: abdominal pain and used Fentanyl Tts (dosage: NA) starting NS. After starting Fentanyl Tts the patient began experiencing various side effects, including: Delirium, Personality Disorder, Cognitive Disorder, Hyperaesthesia, Abdominal Pain, AnxietyAdditional drugs used concurrently: NA.The patient was hospitalized. Although Fentanyl Tts demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Delirium, may still occur.
Fentanyl Side Effect Report#9925758
Toxicity To Various Agents
This Toxicity To Various Agents 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: NA. On NS this consumer started treatment with Fentanyl (dosage: NA). The following drugs were being taken at the same time:
  • Alprazolam
When using Fentanyl, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Fentanyl Side Effect Report#9925751
Toxicity To Various Agents
This Toxicity To Various Agents side effect was reported by a consumer or non-health professional from US. A 52-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fentanyl (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Diphenhydramine
.After starting to take Fentanyl the consumer reported adverse symptoms, such as: Toxicity To Various AgentsThese side effects may potentially be related to Fentanyl.
Fentanyl Side Effect Report#9925085
Hospitalisation, Abnormal Behaviour, Lethargy, Dysphagia, Hypokinesia, Heart Rate Decreased, Somnolence
This is a report of a 69-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Fentanyl (dosage: 75 Ug, Unk, start time:
Jul 23, 2013), combined with: NA. and developed a serious reaction and side effect(s): Hospitalisation, Abnormal Behaviour, Lethargy, Dysphagia, Hypokinesia, Heart Rate Decreased, Somnolence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentanyl treatment in female patients, resulting in Death side effect. The patient was hospitalized.
Fentanyl Side Effect Report#9918196
Depressed Level Of Consciousness, Coma, Respiratory Arrest
This report suggests a potential Fentanyl Depressed Level Of Consciousness side effect(s) that can have serious consequences. A 26-year-old female patient (weight: NA) from TR was diagnosed with the following symptoms/conditions: NA and used Fentanyl (dosage: 4 X 10mg Patches, 100 Micro/h [sic] Release Rate) starting NS. After starting Fentanyl the patient began experiencing various side effects, including: Depressed Level Of Consciousness, Coma, Respiratory ArrestAdditional drugs used concurrently: NA.The patient was hospitalized. Although Fentanyl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Depressed Level Of Consciousness, may still occur.
Fentanyl Side Effect Report#9917744
Memory Impairment, Dizziness, Headache, Somnolence, Confusional State
This Memory Impairment problem was reported by a consumer or non-health professional from US. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: complex regional pain syndrome. On 201401 this consumer started treatment with Fentanyl-50 (watson Laboratories) (dosage: 1 Patch Every 3 Days). The following drugs were being taken at the same time: NA. When using Fentanyl-50 (watson Laboratories), the patient experienced the following unwanted symptoms/side effects: Memory Impairment, Dizziness, Headache, Somnolence, Confusional StateAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Memory Impairment, may become evident only after a product is in use by the general population.
Fentanyl Side Effect Report#9916508
Loss Of Consciousness, Respiratory Arrest, Sinus Tachycardia, Overdose
This Loss Of Consciousness side effect was reported by a health professional from TR. A 26-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fentanyl (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fentanyl the consumer reported adverse symptoms, such as: Loss Of Consciousness, Respiratory Arrest, Sinus Tachycardia, OverdoseThese side effects may potentially be related to Fentanyl. The patient was hospitalized.
Fentanyl Side Effect Report#9916315
Impaired Work Ability
This is a report of a 62-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: spinal pain, who was treated with Fentanyl Transdermal System (dosage: 1 Patch, Every 3 Days, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Impaired Work Ability after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentanyl Transdermal System treatment in female patients, resulting in Impaired Work Ability side effect.
Fentanyl Side Effect Report#9916102
Unresponsive To Stimuli, Incorrect Dose Administered
This report suggests a potential Fentanyl Unresponsive To Stimuli side effect(s) that can have serious consequences. A 2-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Fentanyl (dosage: NA) starting NS. After starting Fentanyl the patient began experiencing various side effects, including: Unresponsive To Stimuli, Incorrect Dose AdministeredAdditional drugs used concurrently: NA. Although Fentanyl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Unresponsive To Stimuli, may still occur.
Fentanyl Side Effect Report#9914118
Pulmonary Congestion, Pulmonary Oedema, Cardiomegaly, Left Ventricular Hypertrophy, Hypertensive Cardiomyopathy, Coronary Artery Stenosis, Arteriosclerosis Coronary Artery, Pneumonia, Contusion
This Pulmonary Congestion problem was reported by a health professional from US. A 36-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Fentanyl (dosage: NA). The following drugs were being taken at the same time:
  • Hydrocodone
When using Fentanyl, the patient experienced the following unwanted symptoms/side effects: Pulmonary Congestion, Pulmonary Oedema, Cardiomegaly, Left Ventricular Hypertrophy, Hypertensive Cardiomyopathy, Coronary Artery Stenosis, Arteriosclerosis Coronary Artery, Pneumonia, ContusionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pulmonary Congestion, may become evident only after a product is in use by the general population.
Fentanyl Side Effect Report#9914109
Hypoxic-ischaemic Encephalopathy, Toxicity To Various Agents
This Hypoxic-ischaemic Encephalopathy side effect was reported by a consumer or non-health professional from US. A 44-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Fentanyl (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Fentanyl the consumer reported adverse symptoms, such as: Hypoxic-ischaemic Encephalopathy, Toxicity To Various AgentsThese side effects may potentially be related to Fentanyl.
Fentanyl Side Effect Report#9913937
Toxicity To Various Agents
This is a report of a 42-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Fentanyl (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Toxicity To Various Agents after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Fentanyl treatment in female patients, resulting in Toxicity To Various Agents side effect.


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The appearance of Fentanyl 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 Fentanyl Side Effects for Women?

Women Side EffectsReports
Pain 553
Product Quality Issue 508
Nausea 418
Overdose 313
Vomiting 290
Product Adhesion Issue 285
Hyperhidrosis 272
Dizziness 268
Somnolence 252
Dyspnoea 238

What are common Fentanyl Side Effects for Men?

Men Side EffectsReports
Pain 299
Product Quality Issue 264
Overdose 244
Death 207
Nausea 196
Somnolence 184
Hyperhidrosis 181
Vomiting 160
Dyspnoea 143
Loss Of Consciousness 139

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.

    Fentanyl 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 Fentanyl Side Effects

    Did You Have a Fentanyl Side Effect?

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    How Effective is Fentanyl for You?

    Exceeded Expectations
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    Fentanyl Safety Alerts, Active Ingredients, Usage Information

    NDC0093-6900
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameFentanyl
    NameFentanyl
    Dosage FormPATCH, EXTENDED RELEASE
    RouteTRANSDERMAL
    On market since20081222
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)FENTANYL
    Strength(s)25
    Unit(s)ug/h
    Pharma ClassFull Opioid Agonists [MoA],Opioid Agonist [EPC]

    Fentanyl Dosage, Warnings, Usage.

    Side Effects reported to FDA: 9439

    Fentanyl safety alerts: 2014 2010 2008 2007 2005 2004

    Reported deaths: 1070

    Reported hospitalizations: 1022

    Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified

    [Posted 10/22/2010]

     

    UPDATED 11/05/2010. Consumers encouraged to return any product in their possession from the October 2010 recall.

    AUDIENCE: Pharmacist, Anesthesia

    ISSUE: FDA notified healthcare professionals and patients that laboratory testing identified a patch that released its active ingredient faster than the approved specification. An accelerated release of Fentanyl can lead to adverse events for at-risk patients, including excessive sedation, respiratory depression, hypoventilation (slow breathing), and apnea (temporary suspension of breathing). 

    BACKGROUND: Fentanyl Transdermal System is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around-the-clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids. The product is manufactured for Actavis by Corium International in the United States.

    RECOMMENDATION: Wholesalers and retailers are being asked to return the product they have on hand or in stock. See the Press Release for recalled product lots. The Control/Lot number appears on the bottom of the product box and on the black and white side of each individual patch packaging, in the lower left corner.
     
    Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [11/04/2010 - Press Release - Actavis, Inc.]
    [10/21/2010 - Press Release - Actavis, Inc.]

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