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Nucynta (Tapentadol) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Nucynta (Tapentadol) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (255)
Death (22)
Life Threatening Events (29)
Disability (5)

Reports by Reaction Type

Hallucination (21)Drug Ineffective (20)Dizziness (20)Dyspnoea (20)Nausea (19)Confusional State (17)Feeling Abnormal (17)Depression (16)Withdrawal Syndrome (16)Anxiety (14)Insomnia (14)Wrong Technique in Drug Usage Process (12)

Below are a few examples of reports where side effects / adverse reactions may be related to Nucynta (Tapentadol). For a complete list or a specific selection of reports, please use the links above.

Possible Nucynta side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male, weighing 117.0 kg (257.5 pounds)

Reactions: Back Pain, Gout, Limb Injury, Bruxism, Memory Impairment, Hypoaesthesia, Hypertension

Drug(s) suspected as cause:
Nucynta



Possible Nucynta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female

Reactions: Blood Pressure Increased, Irritability, Palpitations, Insomnia, Panic Disorder, Feeling Abnormal

Drug(s) suspected as cause:
Nucynta



Possible Nucynta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: female, weighing 96.2 kg (211.6 pounds)

Reactions: Product Quality Issue, Hot Flush, Pain, Depression, Withdrawal Syndrome

Drug(s) suspected as cause:
Nucynta

Other drugs received by patient: Aspirin; Unknown Medication; Ocuvite NOS; Fluticasone Propionate; Prilosec; Vitamins NOS; Calcium; Xanax; Hydrochlorothiazide; Cinnamon; Celebrex; Turmeric; Lasix; Metoprolol Succinate Extended Release; Prilosec; Pravastatin



Possible Nucynta side effects in male

Reported by a physician from United States on 2012-08-24

Patient: male, weighing 81.6 kg (179.6 pounds)

Reactions: Chest Discomfort

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Nucynta

Other drugs received by patient: Clonidine Hydrochloride



Possible Nucynta side effects in female

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

Patient: female, weighing 86.2 kg (189.6 pounds)

Reactions: Pneumonia, Empyema

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nucynta

Other drugs received by patient: Lyrica; Citalopram Hydrobromide; Clonazepam



Possible Nucynta side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: 38 year old female

Reactions: Abdominal Pain, Pallor, Cerebrovascular Accident, Ileus Paralytic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nucynta

Other drugs received by patient: Zanaflex; Vitamin D



Possible Nucynta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Herpes Zoster

Drug(s) suspected as cause:
Nucynta



Possible Nucynta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female, weighing 61.7 kg (135.7 pounds)

Reactions: Syncope, Hypotension, Feeling Abnormal, Asthenia, Shock

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nucynta

Other drugs received by patient: Levetiracetam; AN Unknown Medication



Possible Nucynta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female

Reactions: Blood Pressure Increased, Irritability, Palpitations, Insomnia, Feeling Abnormal, Panic Disorder

Drug(s) suspected as cause:
Nucynta



Possible Nucynta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female

Reactions: Procedural Pain, Nausea, Inadequate Analgesia, Cyst, Headache, Drug Abuse, Hyperhidrosis, Withdrawal Syndrome, Feeling of Body Temperature Change, Back Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nucynta
    Administration route: Oral

Nucynta
    Administration route: Oral
    Start date: 2012-08-01

Nucynta
    Administration route: Oral
    Indication: Back Pain
    End date: 2012-08-01



Possible Nucynta side effects in 38 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: 38 year old female

Reactions: Abdominal Pain, Cerebrovascular Accident, Pallor, Ileus Paralytic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Nucynta

Other drugs received by patient: Vitamin D; Zanaflex



Possible Nucynta side effects in

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient:

Reactions: Incorrect Route of Drug Administration, Vein Pain, Pain, Vasodilatation, Drug Abuse

Drug(s) suspected as cause:
Nucynta



Possible Nucynta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-13

Patient: female, weighing 72.6 kg (159.7 pounds)

Reactions: Initial Insomnia, Abnormal Loss of Weight, Paraesthesia

Drug(s) suspected as cause:
Nucynta
    Dosage: as needed
    Administration route: Oral
    Indication: Pain
    Start date: 2012-07-23
    End date: 2012-08-03

Xarelto
    Administration route: Oral
    Indication: HIP Arthroplasty
    Start date: 2012-07-23

Xarelto
    Administration route: Oral
    Indication: Thrombosis Prophylaxis
    Start date: 2012-07-23

Other drugs received by patient: Synthroid; Keppra; Lansoprazole; Dexamethasone



Possible Nucynta side effects in

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient:

Reactions: Mania, Drug Ineffective, Insomnia, Disorientation, Feeling Abnormal

Drug(s) suspected as cause:
Nucynta



Possible Nucynta side effects in 23 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 23 year old female, weighing 60.3 kg (132.7 pounds)

Reactions: Partial Seizures, Nausea, Dizziness

Drug(s) suspected as cause:
Nucynta



Possible Nucynta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: female, weighing 106.1 kg (233.5 pounds)

Reactions: Malaise, Hot Flush, Vomiting Projectile, Disturbance in Attention, Dizziness, Feeling Cold, Tremor

Drug(s) suspected as cause:
Nucynta

Other drugs received by patient: Levothyroxine Sodium



Possible Nucynta side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-06

Patient:

Reactions: Drug Ineffective, Substance Abuse

Drug(s) suspected as cause:
Nucynta
    Dosage: once
    Indication: Product Used FOR Unknown Indication

Oxycodone HCL
    Dosage: once in a day
    Indication: Product Used FOR Unknown Indication

Oxymorphone Hydrochloride
    Dosage: once in a day
    Indication: Product Used FOR Unknown Indication



Possible Nucynta side effects in

Reported by a physician from United States on 2012-08-03

Patient:

Reactions: Serotonin Syndrome

Drug(s) suspected as cause:
Nucynta



Possible Nucynta side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female, weighing 72.6 kg (159.7 pounds)

Reactions: Spinal Fusion Surgery, Urinary Tract Infection, Hallucination, Delusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Morphine Sulfate
    Indication: Procedural Pain
    Start date: 2012-06-14
    End date: 2012-06-15

Nucynta
    Dosage: 3 times daily
    Administration route: Oral
    Start date: 2012-06-15
    End date: 2012-06-19

Nucynta
    Dosage: 3 times daily
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2012-06-15
    End date: 2012-06-19

Nucynta
    Dosage: twice daily
    Administration route: Oral
    Start date: 2012-03-01
    End date: 2012-06-19

Nucynta
    Dosage: twice daily
    Administration route: Oral
    Start date: 2012-03-01
    End date: 2012-06-19

Nucynta
    Dosage: twice daily
    Administration route: Oral
    Start date: 2012-07-06

Nucynta
    Dosage: twice daily
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-07-06

Oxycodone HCL and Acetaminophen
    Dosage: 5/325mg daily as needed
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-15
    End date: 2012-06-19

Percocet
    Dosage: 7.5/325 7.5mg once daily at night
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-17
    End date: 2012-06-19

Vicodin
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-15
    End date: 2012-06-17

Other drugs received by patient: Topiramate; Xanax; Celexa



Possible Nucynta side effects in

Reported by a physician from United States on 2012-07-27

Patient:

Reactions: Serotonin Syndrome

Drug(s) suspected as cause:
Nucynta



Possible Nucynta side effects in 77 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-25

Patient: 77 year old female

Reactions: Dysuria, Urinary Retention

Drug(s) suspected as cause:
Nucynta



Possible Nucynta side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-24

Patient: female, weighing 89.4 kg (196.6 pounds)

Reactions: Drug Effect Decreased, Tendon Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dilaudid
    Dosage: as needed
    Administration route: Oral
    Indication: Pain
    Start date: 2011-10-01
    End date: 2012-01-01

Nucynta
    Administration route: Oral
    Indication: Pain

Nucynta
    Dosage: every 6 hours
    Administration route: Oral
    Start date: 2011-06-01

Other drugs received by patient: Lovastatin; Lisinopril; Metformin Hydrochloride; Toprol-XL



Possible Nucynta side effects in 40 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-20

Patient: 40 year old female

Reactions: Peripheral Coldness, Urine Output Decreased, Alanine Aminotransferase Increased, Tachycardia, Troponin Increased, Hyperhidrosis, Somnolence, Generalised Oedema, Cyanosis, Aspartate Aminotransferase Increased, Suicide Attempt, Multiple Drug Overdose, Blood Creatinine Increased, Stevens-Johnson Syndrome

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Anticonvulsant
    Indication: Product Used FOR Unknown Indication

Beta Blockers, NOS
    Indication: Product Used FOR Unknown Indication

Gastrointestinal Agent
    Indication: Product Used FOR Unknown Indication

Nucynta
    Dosage: 17 nucynta 100 mg
    Indication: Product Used FOR Unknown Indication

Proton Pump Inhibitors
    Indication: Product Used FOR Unknown Indication

Ropinirole
    Indication: Product Used FOR Unknown Indication

Thyroid Preparations
    Indication: Product Used FOR Unknown Indication

Tramadol HCL
    Dosage: 60 tramadol 37.5 mg,
    Indication: Product Used FOR Unknown Indication



Possible Nucynta side effects in 19 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-19

Patient: 19 year old male, weighing 198.0 kg (435.5 pounds)

Reactions: Sudden Death, Drug Interaction, Respiratory Depression, Toxicity To Various Agents

Adverse event resulted in: death

Drug(s) suspected as cause:
Nucynta

Other drugs received by patient possibly interacting with the suspect drug:
Diazepam
    Indication: Product Used FOR Unknown Indication



Possible Nucynta side effects in female

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

Patient: female, weighing 72.6 kg (159.7 pounds)

Reactions: Spinal Fusion Surgery, Urinary Tract Infection, Hallucination, Delusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Morphine
    Indication: Procedural Pain
    Start date: 2012-06-14
    End date: 2012-06-15

Nucynta
    Dosage: twice daily
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-07-06

Nucynta
    Dosage: twice daily
    Administration route: Oral
    Start date: 2012-07-06

Nucynta
    Dosage: 3 times daily
    Administration route: Oral
    Start date: 2012-06-15
    End date: 2012-06-19

Nucynta
    Dosage: twice daily
    Administration route: Oral
    Start date: 2012-03-01
    End date: 2012-06-19

Nucynta
    Dosage: 3 times daily
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2012-06-15
    End date: 2012-06-19

Nucynta
    Dosage: twice daily
    Administration route: Oral
    Start date: 2012-03-01
    End date: 2012-06-19

Oxycodone HCL and Acetaminophen
    Dosage: 5/325mg daily as needed
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-15
    End date: 2012-06-19

Percocet
    Dosage: 7.5/325 7.5mg once daily at night
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-17
    End date: 2012-06-19

Vicodin
    Administration route: Oral
    Indication: Procedural Pain
    Start date: 2012-06-15
    End date: 2012-06-17

Other drugs received by patient: Topiramate; Celexa; Xanax



Possible Nucynta side effects in female

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

Patient: female, weighing 111.1 kg (244.5 pounds)

Reactions: Meniscus Lesion, Pain, Therapeutic Response Unexpected, Nervousness

Drug(s) suspected as cause:
Nucynta
    Dosage: 100 mg every 6 hours
    Administration route: Oral
    Start date: 2012-05-01

Nucynta
    Dosage: 75 mg every 6 hours
    Administration route: Oral
    Indication: Spinal Pain
    Start date: 2010-01-01
    End date: 2012-05-01

Nucynta
    Dosage: 75 mg every 6 hours
    Administration route: Oral
    Indication: Neck Pain
    Start date: 2010-01-01
    End date: 2012-05-01

Nucynta
    Dosage: 100 mg every 6 hours
    Administration route: Oral
    Start date: 2012-05-01

Nucynta
    Dosage: 100 mg every 6 hours
    Administration route: Oral
    Indication: Back Pain
    Start date: 2012-05-01

Nucynta
    Dosage: 75 mg every 6 hours
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2012-05-01



Possible Nucynta side effects in 43 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13

Patient: 43 year old female

Reactions: Hypoventilation, Breath Sounds Abnormal, Unresponsive To Stimuli, Tachycardia, Multiple Drug Overdose, Toxicity To Various Agents, Somnolence, Lethargy

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Atenolol
    Indication: Product Used FOR Unknown Indication

Benzodiazepine NOS
    Indication: Product Used FOR Unknown Indication

Beta Blocker Agent
    Indication: Product Used FOR Unknown Indication

Dilaudid

Dilaudid
    Indication: Product Used FOR Unknown Indication

Nucynta
    Indication: Product Used FOR Unknown Indication

Nucynta ER
    Indication: Product Used FOR Unknown Indication

Opiates
    Indication: Product Used FOR Unknown Indication

Propranolol HCL
    Indication: Product Used FOR Unknown Indication



Possible Nucynta side effects in 73 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-13

Patient: 73 year old female

Reactions: Coma, Respiratory Depression, Toxicity To Various Agents, Hypoxia, Acute Lung Injury, Bradycardia, Myocardial Infarction, Apnoea

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Nucynta



Possible Nucynta side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: female, weighing 52.2 kg (114.8 pounds)

Reactions: Fatigue, Drug Ineffective, Withdrawal Syndrome, Thyroid Neoplasm, Feeling Abnormal, Autoimmune Thyroiditis

Drug(s) suspected as cause:
Nucynta
    Dosage: 3 times per day
    Administration route: Oral
    Indication: Back Pain
    End date: 2012-01-01

Nucynta
    Dosage: once a day
    Administration route: Oral
    Start date: 2012-06-27

Nucynta
    Dosage: 50mg or 75mg
    Administration route: Oral

Nucynta
    Dosage: once a day
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-06-27

Nucynta
    Dosage: once daily
    Administration route: Oral
    Start date: 2012-01-01
    End date: 2012-01-01

Oxycodone HCL and Acetaminophen
    Dosage: 10mg/325mg
    Indication: Back Pain
    Start date: 2012-01-01



Possible Nucynta side effects in female

Reported by a physician from United States on 2012-07-06

Patient: female

Reactions: Death, Overdose

Adverse event resulted in: death

Drug(s) suspected as cause:
Duragesic-100
    Indication: Product Used FOR Unknown Indication

Nucynta
    Indication: Product Used FOR Unknown Indication

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