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Nucynta Side Effects

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Common Nucynta Side Effects


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

Dizziness (51)
Nausea (49)
Hallucination (44)
Confusional State (44)
Dyspnoea (40)
Headache (35)
Loss Of Consciousness (34)
Depression (30)
Serotonin Syndrome (30)
Palpitations (28)
Tremor (27)
Vomiting (26)
Hypotension (26)
Overdose (26)
Feeling Abnormal (25)
Toxicity To Various Agents (24)
Insomnia (23)
Hypertension (22)
Convulsion (22)
Blood Pressure Increased (21)

➢ 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.

Nucynta Side Effects Reported to FDA



Nucynta Side Effect Report#9628882
Suicide Attempt, Altered State Of Consciousness, Miosis, Confusional State, Extra Dose Administered
This is a report of a 74-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Nucynta Er (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Suicide Attempt, Altered State Of Consciousness, Miosis, Confusional State, Extra Dose Administered after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nucynta Er treatment in female patients, resulting in Suicide Attempt side effect. The patient was hospitalized.
Nucynta Side Effect Report#9626325
Toxicity To Various Agents, Overdose
This report suggests a potential Nucynta Toxicity To Various Agents side effect(s) that can have serious consequences. A 17-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: headache and used Nucynta (dosage: NA) starting
Apr 10, 2013. After starting Nucynta the patient began experiencing various side effects, including: Toxicity To Various Agents, OverdoseAdditional drugs used concurrently: NA. Although Nucynta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Toxicity To Various Agents, may still occur.
Nucynta Side Effect Report#9625690
Tooth Loss, Gingivitis
This Tooth Loss problem was reported by a physician from CA. A 37-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain. On
Apr 16, 2012 this consumer started treatment with Nucynta Cr (dosage: Twice Daily). The following drugs were being taken at the same time:
  • Cymbalta (Per Day)
  • Cymbalta (Per Day)
  • Toradol
  • Wellbutrin Xl
  • Amitriptyline
  • Zopiclone
When using Nucynta Cr, the patient experienced the following unwanted symptoms/side effects: Tooth Loss, GingivitisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Tooth Loss, may become evident only after a product is in use by the general population.
Nucynta Side Effect Report#9625687
Intentional Overdose, Hypertension, Suicide Attempt, Serotonin Syndrome, Depressed Level Of Consciousness, Respiratory Depression, Lethargy, Miosis, Nystagmus
This Intentional Overdose side effect was reported by a health professional from US. A 18-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nucynta Er (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Acetaminophen
.After starting to take Nucynta Er the consumer reported adverse symptoms, such as: Intentional Overdose, Hypertension, Suicide Attempt, Serotonin Syndrome, Depressed Level Of Consciousness, Respiratory Depression, Lethargy, Miosis, NystagmusThese side effects may potentially be related to Nucynta Er. The patient was hospitalized.
Nucynta Side Effect Report#9614377
Overdose, Suicide Attempt, Unresponsive To Stimuli, Convulsion, Mydriasis, Blood Glucose Increased, Blood Lactic Acid Increased, Sinus Tachycardia, Stridor
This is a report of a 14-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Nucynta Er (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Overdose, Suicide Attempt, Unresponsive To Stimuli, Convulsion, Mydriasis, Blood Glucose Increased, Blood Lactic Acid Increased, Sinus Tachycardia, Stridor after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nucynta Er treatment in female patients, resulting in Overdose side effect. The patient was hospitalized.
Nucynta Side Effect Report#9614375
Respiratory Disorder, Heart Rate Increased, Hypopnoea, Dyspnoea, Chest Pain, Depression, Hypertension, Feeling Abnormal
This report suggests a potential Nucynta Er Respiratory Disorder side effect(s) that can have serious consequences. A 58-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Nucynta Er (dosage: Two Per Day) starting 201309. After starting Nucynta Er the patient began experiencing various side effects, including: Respiratory Disorder, Heart Rate Increased, Hypopnoea, Dyspnoea, Chest Pain, Depression, Hypertension, Feeling AbnormalAdditional drugs used concurrently: NA. Although Nucynta Er demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Respiratory Disorder, may still occur.
Nucynta Side Effect Report#9614374
Unresponsive To Stimuli, Respiratory Depression, Depressed Level Of Consciousness, Hypotension, Tachycardia, Convulsion, Bradycardia, Pneumonia, Toxicity To Various Agents
This Unresponsive To Stimuli problem was reported by a health professional from US. A 28-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Nucynta Er (dosage: NA). The following drugs were being taken at the same time:
  • Oxycodone
When using Nucynta Er, the patient experienced the following unwanted symptoms/side effects: Unresponsive To Stimuli, Respiratory Depression, Depressed Level Of Consciousness, Hypotension, Tachycardia, Convulsion, Bradycardia, Pneumonia, Toxicity To Various AgentsThe 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 Unresponsive To Stimuli, may become evident only after a product is in use by the general population.
Nucynta Side Effect Report#9613114
Suicide Attempt, Toxicity To Various Agents, Apnoea, Unresponsive To Stimuli, Respiratory Rate Decreased, Intentional Overdose, Alanine Aminotransferase Increased
This Suicide Attempt side effect was reported by a health professional from US. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nucynta (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Acetaminophen
  • Acetaminophen
  • Benzodiazepine Nos
  • Oxycodone
  • Antipsychotics
.After starting to take Nucynta the consumer reported adverse symptoms, such as: Suicide Attempt, Toxicity To Various Agents, Apnoea, Unresponsive To Stimuli, Respiratory Rate Decreased, Intentional Overdose, Alanine Aminotransferase IncreasedThese side effects may potentially be related to Nucynta. The patient was hospitalized.
Nucynta Side Effect Report#9570993
Bruxism, Tooth Fracture, Dyskinesia
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: back pain, who was treated with Nucynta (dosage: Once A Day, start time: 2011), combined with: NA. and developed a serious reaction and side effect(s): Bruxism, Tooth Fracture, Dyskinesia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nucynta treatment in female patients, resulting in Bruxism side effect.
Nucynta Side Effect Report#9565041
Renal Abscess
This report suggests a potential Nucynta Ir Renal Abscess side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Nucynta Ir (dosage: 75 Mg ^q6 As Needed^) starting
Jul 03, 2013. After starting Nucynta Ir the patient began experiencing various side effects, including: Renal AbscessAdditional drugs used concurrently:
  • Nucynta Er (Twice A Day)
  • Fentanyl Citrate
  • Fentanyl (Three Times A Day)
Although Nucynta Ir demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Abscess, may still occur.
Nucynta Side Effect Report#9543360
Renal Failure, Cardiac Failure Congestive, Hepatic Failure, Pneumonia, Weight Decreased
This Renal Failure problem was reported by a consumer or non-health professional from US. A 56-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pain. On 201208 this consumer started treatment with Nucynta Er (dosage: Twice Daily). The following drugs were being taken at the same time: NA. When using Nucynta Er, the patient experienced the following unwanted symptoms/side effects: Renal Failure, Cardiac Failure Congestive, Hepatic Failure, Pneumonia, Weight DecreasedThe 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 Renal Failure, may become evident only after a product is in use by the general population.
Nucynta Side Effect Report#9542387
Blood Pressure Decreased
This Blood Pressure Decreased side effect was reported by a consumer or non-health professional from US. A 58-year-old female patient (weight:NA) experienced the following symptoms/conditions: fibromyalgia.The patient was prescribed Nucynta (drug dosage: NA), which was initiated on
Jan 04, 2012. Concurrently used drugs:
  • Savella
.After starting to take Nucynta the consumer reported adverse symptoms, such as: Blood Pressure DecreasedThese side effects may potentially be related to Nucynta.
Nucynta Side Effect Report#9539573
Cerebral Ischaemia, Demyelination, Psychiatric Symptom, Overdose, Hypersomnia
This is a report of a 62-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: spinal fusion surgery, who was treated with Nucynta (dosage: NA, start time: 2013), combined with: NA. and developed a serious reaction and side effect(s): Cerebral Ischaemia, Demyelination, Psychiatric Symptom, Overdose, Hypersomnia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nucynta treatment in male patients, resulting in Cerebral Ischaemia side effect.
Nucynta Side Effect Report#9504432
Loss Of Consciousness, Hypotension, Toxicity To Various Agents, Dysarthria, Aspartate Aminotransferase Increased
This report suggests a potential Nucynta Loss Of Consciousness 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 Nucynta (dosage: NA) starting NS. After starting Nucynta the patient began experiencing various side effects, including: Loss Of Consciousness, Hypotension, Toxicity To Various Agents, Dysarthria, Aspartate Aminotransferase IncreasedAdditional drugs used concurrently:
  • Ethanol
Although Nucynta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Loss Of Consciousness, may still occur.
Nucynta Side Effect Report#9504431
Intentional Overdose, Altered State Of Consciousness, Hypotension, Oxygen Saturation Decreased, Tachycardia, Tachypnoea, Somnolence
This Intentional Overdose problem was reported by a health professional from US. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Nucynta Er (dosage: NA). The following drugs were being taken at the same time: NA. When using Nucynta Er, the patient experienced the following unwanted symptoms/side effects: Intentional Overdose, Altered State Of Consciousness, Hypotension, Oxygen Saturation Decreased, Tachycardia, Tachypnoea, SomnolenceAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Intentional Overdose, may become evident only after a product is in use by the general population.
Nucynta Side Effect Report#9503784
Loss Of Consciousness, Completed Suicide, Convulsion, Overdose, Toxicity To Various Agents, Sinus Tachycardia, Pyrexia, Mental Status Changes
This Loss Of Consciousness side effect was reported by a health professional from US. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nucynta (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Nucynta the consumer reported adverse symptoms, such as: Loss Of Consciousness, Completed Suicide, Convulsion, Overdose, Toxicity To Various Agents, Sinus Tachycardia, Pyrexia, Mental Status ChangesThese side effects may potentially be related to Nucynta. The patient was hospitalized.
Nucynta Side Effect Report#9494684
Suicide Attempt, Intentional Overdose, Cardiac Arrest, Respiratory Depression, Fluid Retention, Aspiration, Hypotension, Nausea, Pain
This is a report of a 38-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: back pain, who was treated with Nucynta (dosage: Supposedly Took 160 Plus Tablets Of 50 Mg Tapentadol Hydrochloride, start time: NS), combined with:
  • Diazepam
  • Cyclobenzaprine
  • Pregabalin
and developed a serious reaction and side effect(s): Suicide Attempt, Intentional Overdose, Cardiac Arrest, Respiratory Depression, Fluid Retention, Aspiration, Hypotension, Nausea, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nucynta treatment in male patients, resulting in Suicide Attempt side effect. The patient was hospitalized.
Nucynta Side Effect Report#9465874
Retching, Vomiting, Weight Decreased, Blood Magnesium Decreased, Headache
This report suggests a potential Nucynta Er Retching side effect(s) that can have serious consequences. A male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: headache and used Nucynta Er (dosage: 50 Mg As Needed Twice Daily (started End Of Jun And Begining Of Jul-2013)) starting 2013. After starting Nucynta Er the patient began experiencing various side effects, including: Retching, Vomiting, Weight Decreased, Blood Magnesium Decreased, HeadacheAdditional drugs used concurrently: NA.The patient was hospitalized. Although Nucynta Er demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Retching, may still occur.
Nucynta Side Effect Report#9464548
Gastrooesophageal Reflux Disease, Ligament Injury, Depression, Weight Decreased, Loss Of Employment
This Gastrooesophageal Reflux Disease problem was reported by a consumer or non-health professional from US. A 46-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: abdominal pain. On 2011 this consumer started treatment with Nucynta (dosage: 50 Mg, Three Times A Day As Needed). The following drugs were being taken at the same time:
  • Prilosec
  • Prilosec
When using Nucynta, the patient experienced the following unwanted symptoms/side effects: Gastrooesophageal Reflux Disease, Ligament Injury, Depression, Weight Decreased, Loss Of EmploymentAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastrooesophageal Reflux Disease, may become evident only after a product is in use by the general population.
Nucynta Side Effect Report#9461710
Loss Of Consciousness, Hallucination, Auditory, Insomnia, Tremor
This Loss Of Consciousness side effect was reported by a consumer or non-health professional from US. A 82-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Nucynta Ir (drug dosage: NA), which was initiated on
Feb 14, 2013. Concurrently used drugs:
  • Nucynta Er
.After starting to take Nucynta Ir the consumer reported adverse symptoms, such as: Loss Of Consciousness, Hallucination, Auditory, Insomnia, TremorThese side effects may potentially be related to Nucynta Ir.
Nucynta Side Effect Report#9461418
Sleep Terror, Hyperhidrosis, Cold Sweat, Incoherent, Headache, Sinus Disorder
This is a report of a 70-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Nucynta Er (dosage: NA, start time:
Aug 01, 2013), combined with: NA. and developed a serious reaction and side effect(s): Sleep Terror, Hyperhidrosis, Cold Sweat, Incoherent, Headache, Sinus Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nucynta Er treatment in male patients, resulting in Sleep Terror side effect. The patient was hospitalized.
Nucynta Side Effect Report#9458029
Spinal Column Stenosis, Pain, Headache, Hyperhidrosis, Chills, Abdominal Pain
This report suggests a potential Nucynta Er Spinal Column Stenosis side effect(s) that can have serious consequences. A 53-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: back pain,hypertension,atrial fibrillation and used Nucynta Er (dosage: 150 Mg Twice Daily) starting 2006. After starting Nucynta Er the patient began experiencing various side effects, including: Spinal Column Stenosis, Pain, Headache, Hyperhidrosis, Chills, Abdominal PainAdditional drugs used concurrently:
  • Lisinopril
  • Diltiazem
The patient was hospitalized. Although Nucynta Er demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Spinal Column Stenosis, may still occur.
Nucynta Side Effect Report#9445688
Dissociation
This Dissociation problem was reported by a consumer or non-health professional from US. A 66-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: back pain. On
May 15, 2013 this consumer started treatment with Nucynta Ir (dosage: Twice A Day). The following drugs were being taken at the same time: NA. When using Nucynta Ir, the patient experienced the following unwanted symptoms/side effects: DissociationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dissociation, may become evident only after a product is in use by the general population.
Nucynta Side Effect Report#9400476
Amnesia, Dyspnoea, Palpitations
This Amnesia side effect was reported by a consumer or non-health professional from US. A 25-year-old female patient (weight:NA) experienced the following symptoms/conditions: thoracic outlet syndrome.The patient was prescribed Nucynta (drug dosage: 2 Times A Day), which was initiated on 201306. Concurrently used drugs: NA..After starting to take Nucynta the consumer reported adverse symptoms, such as: Amnesia, Dyspnoea, PalpitationsThese side effects may potentially be related to Nucynta.
Nucynta Side Effect Report#9397518
Pulmonary Embolism, Hysterectomy, Migraine, Dizziness
This is a report of a 49-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain, who was treated with Nucynta (dosage: 50 Mg (25mg) Twice Daily Oral, start time:
May 10, 2013), combined with:
  • Dilaudid
  • Proventil
  • Combivent
  • Coumadin
  • Enoxaparin
  • Fioricet
  • Lasix
  • Vitamin D
and developed a serious reaction and side effect(s): Pulmonary Embolism, Hysterectomy, Migraine, Dizziness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Nucynta treatment in female patients, resulting in Pulmonary Embolism side effect. The patient was hospitalized.


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The appearance of Nucynta 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 Nucynta Side Effects for Women?

Women Side EffectsReports
Dizziness 42
Nausea 40
Dyspnoea 30
Confusional State 25
Hallucination 25
Headache 25
Loss Of Consciousness 22
Depression 20
Palpitations 20
Blood Pressure Increased 18

What are common Nucynta Side Effects for Men?

Men Side EffectsReports
Confusional State 19
Hallucination 19
Serotonin Syndrome 17
Disorientation 14
Loss Of Consciousness 12
Vomiting 12
Dysarthria 11
Aggression 10
Depression 10
Dyspnoea 10

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.

    Nucynta 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.

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    Nucynta Safety Alerts, Active Ingredients, Usage Information

    NDC16590-289
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameNUCYNTA
    Nametapentadol hydrochloride
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20090601
    LabelerStat Rx USA
    Active Ingredient(s)TAPENTADOL HYDROCHLORIDE
    Strength(s)100
    Unit(s)mg/1
    Pharma ClassOpioid Agonist [EPC],Opioid Agonists [MoA]

    More About Nucynta

    Side Effects reported to FDA: 535

    Nucynta safety alerts: No

    Reported deaths: 29

    Reported hospitalizations: 143

    Latest Nucynta clinical trials