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
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 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 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 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 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 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 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 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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