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Nucynta Side Effects

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.

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.

Nucynta Side Effects Reported to FDA

The following 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.


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.
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 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). The consumer presented with:
  • Suicide Attempt
  • Altered State Of Consciousness
  • Miosis
  • Confusional State
  • Extra Dose Administered
which developed 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.

Toxicity To Various Agents, Overdose
This report suggests a potential Nucynta Toxicity To Various Agents, Overdose 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. Soon after starting Nucynta the patient began experiencing various side effects, including:
  • Toxicity To Various Agents
  • Overdose
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.

Tooth Loss, Gingivitis
This Tooth Loss, Gingivitis 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 commencing Nucynta Cr, the patient experienced the following unwanted symptoms/side effects:
  • Tooth Loss
  • Gingivitis
Although 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.

Intentional Overdose, Hypertension, Suicide Attempt, Serotonin Syndrome, Depressed Level Of Consciousness, Respiratory Depression, Lethargy, Miosis, Nystagmus
This is a report of a 18-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Nucynta Er (dosage: NA) starting NS. Concurrently used drugs:
  • Acetaminophen
Soon after that, the consumer experienced the following side effects:
  • Intentional Overdose
  • Hypertension
  • Suicide Attempt
  • Serotonin Syndrome
  • Depressed Level Of Consciousness
  • Respiratory Depression
  • Lethargy
  • Miosis
  • Nystagmus
The patient was hospitalized. This opens a possibility that Nucynta Er treatment could cause the above reactions, including intentional overdose, and some female subjects may be more susceptible.


Overdose, Suicide Attempt, Unresponsive To Stimuli, Convulsion, Mydriasis, Blood Glucose Increased, Blood Lactic Acid Increased, Sinus Tachycardia, Stridor
A 14-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Nucynta Er treatment (dosage: NA) on NS. Soon after starting Nucynta Er treatment, the subject experienced various side effects, including:
  • Overdose
  • Suicide Attempt
  • Unresponsive To Stimuli
  • Convulsion
  • Mydriasis
  • Blood Glucose Increased
  • Blood Lactic Acid Increased
  • Sinus Tachycardia
  • Stridor
Concurrently used drugs: NA.The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Nucynta Er.

Respiratory Disorder, Heart Rate Increased, Hypopnoea, Dyspnoea, Chest Pain, Depression, Hypertension, Feeling Abnormal
A 58-year-old male patient from US (weight: NA) experienced symptoms, such as: pain and was treated with Nucynta Er(dosage: Two Per Day). The treatment was initiated on 201309. After that a consumer reported the following side effect(s):
  • Respiratory Disorder
  • Heart Rate Increased
  • Hypopnoea
  • Dyspnoea
  • Chest Pain
  • Depression
  • Hypertension
  • Feeling Abnormal
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Nucynta Er efficacy: NA.

Unresponsive To Stimuli, Respiratory Depression, Depressed Level Of Consciousness, Hypotension, Tachycardia, Convulsion, Bradycardia, Pneumonia, Toxicity To Various Agents
In this report, Nucynta Er was administered for the following condition: NA.A 28-year-old male consumer from US (weight: NA) started Nucynta Er treatment (dosage: NA) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Unresponsive To Stimuli
  • Respiratory Depression
  • Depressed Level Of Consciousness
  • Hypotension
  • Tachycardia
  • Convulsion
  • Bradycardia
  • Pneumonia
  • Toxicity To Various Agents
A possible interaction with other drugs could have contributed to this reaction:
  • Oxycodone
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Nucynta Er treatment could be related to the listed above side effect(s).

Suicide Attempt, Toxicity To Various Agents, Apnoea, Unresponsive To Stimuli, Respiratory Rate Decreased, Intentional Overdose, Alanine Aminotransferase Increased
This is a report of the following Nucynta side effect(s):
  • Suicide Attempt
  • Toxicity To Various Agents
  • Apnoea
  • Unresponsive To Stimuli
  • Respiratory Rate Decreased
  • Intentional Overdose
  • Alanine Aminotransferase Increased
A 63-year-old female patient from US (weight: NA) presented with the following condition: NA and received a treatment with Nucynta (dosage: NA) starting: NS.The following concurrently used drugs could have generated interactions:
  • Acetaminophen
  • Acetaminophen
  • Benzodiazepine Nos
  • Oxycodone
  • Antipsychotics
The patient was hospitalized.This report suggests that a Nucynta treatment could be associated with the listed above side effect(s).

Bruxism, Tooth Fracture, Dyskinesia
This Nucynta report was submitted by a female consumer from US (weight: NA). The patient was diagnosed with: back pain and Nucynta was administered (dosage: Once A Day) starting: 2011. The consumer developed a set of symptoms:
  • Bruxism
  • Tooth Fracture
  • Dyskinesia
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Nucynta treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Renal Abscess
This is a report of a possible correlation between Nucynta Ir use and the following symptoms/side effect(s):
  • Renal Abscess
which could contribute to an assessment of Nucynta Ir risk profile.A female consumer from US (weight: NA) was suffering from pain and was treated with Nucynta Ir (dosage: 75 Mg ^q6 As Needed^) starting Jul 03, 2013.Other concurrent medications:
  • Nucynta Er (Twice A Day)
  • Fentanyl Citrate
  • Fentanyl (Three Times A Day)


Renal Failure, Cardiac Failure Congestive, Hepatic Failure, Pneumonia, Weight Decreased
A 56-year-old female patient from US (weight: NA) presented with the following symptoms: pain and after a treatment with Nucynta Er (dosage: Twice Daily) experienced the following side effect(s):
  • Renal Failure
  • Cardiac Failure Congestive
  • Hepatic Failure
  • Pneumonia
  • Weight Decreased
The treatment was started on 201208. Nucynta Er was used in combination with the following drugs: NA.The patient was hospitalized.This report could alert potential Nucynta Er consumers.

Blood Pressure Decreased
In this report, a 58-year-old female patient from US (weight: NA) was affected by a possible Nucynta side effect.The patient was diagnosed with fibromyalgia. After a treatment with Nucynta (dosage: NA, start date: Jan 04, 2012), the patient experienced the following side effect(s):
  • Blood Pressure Decreased
The following simultaneously used drugs could have led to this reaction:
  • Savella
The findings here stress that side effects should be taken into consideration when evaluating a Nucynta treatment.

Cerebral Ischaemia, Demyelination, Psychiatric Symptom, Overdose, Hypersomnia
This is a report of a 62-year-old male patient from US (weight: NA), who used Nucynta (dosage: NA) for a treatment of spinal fusion surgery. After starting a treatment on 2013, the patient experienced the following side effect(s):
  • Cerebral Ischaemia
  • Demyelination
  • Psychiatric Symptom
  • Overdose
  • Hypersomnia
The following drugs could possibly have interacted with the Nucynta treatment NA.Taken together, these observations suggest that a Nucynta treatment could be related to side effect(s), such as Cerebral Ischaemia, Demyelination, Psychiatric Symptom, Overdose, Hypersomnia.

Loss Of Consciousness, Hypotension, Toxicity To Various Agents, Dysarthria, Aspartate Aminotransferase Increased
This loss of consciousness side effect was reported by a health professional from US. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA. The patient was prescribed Nucynta (dosage: NA), which was started on NS. Concurrently used drugs:
  • Ethanol
When starting to take Nucynta the consumer reported the following symptoms:
  • Loss Of Consciousness
  • Hypotension
  • Toxicity To Various Agents
  • Dysarthria
  • Aspartate Aminotransferase Increased
These side effects may potentially be related to Nucynta.

Intentional Overdose, Altered State Of Consciousness, Hypotension, Oxygen Saturation Decreased, Tachycardia, Tachypnoea, Somnolence
This is a Nucynta Er side effect report of a 81-year-old female patient (weight:NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Nucynta Er (dosage:NA, start time: NS), combined with: NA., and developed a serious reaction and a intentional overdose side effect. The patient presented with:
  • Intentional Overdose
  • Altered State Of Consciousness
  • Hypotension
  • Oxygen Saturation Decreased
  • Tachycardia
  • Tachypnoea
  • Somnolence
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Nucynta Er treatment in female patients suffering from NA, resulting in intentional overdose.

Loss Of Consciousness, Completed Suicide, Convulsion, Overdose, Toxicity To Various Agents, Sinus Tachycardia, Pyrexia, Mental Status Changes
This report suggests a potential Nucynta loss of consciousness side effect(s) that can have serious consequences. A 74-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): NA and used Nucynta (dosage: NA) starting NS. Soon after starting Nucynta the patient began experiencing various side effects, including:
  • Loss Of Consciousness
  • Completed Suicide
  • Convulsion
  • Overdose
  • Toxicity To Various Agents
  • Sinus Tachycardia
  • Pyrexia
  • Mental Status Changes
Drugs used concurrently:NA. The patient was hospitalized. Although Nucynta demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as loss of consciousness, may still occur.

Suicide Attempt, Intentional Overdose, Cardiac Arrest, Respiratory Depression, Fluid Retention, Aspiration, Hypotension, Nausea, Pain
This suicide attempt problem was reported by a health professional from US. A 38-year-old male patient (weight: NA) was diagnosed with the following medical condition(s): back pain.On NS a consumer started treatment with Nucynta (dosage: Supposedly Took 160 Plus Tablets Of 50 Mg Tapentadol Hydrochloride). The following drugs/medications were being taken at the same time:
  • Diazepam
  • Cyclobenzaprine
  • Pregabalin
When commencing Nucynta, the patient experienced the following unwanted symptoms /side effects:
  • Suicide Attempt
  • Intentional Overdose
  • Cardiac Arrest
  • Respiratory Depression
  • Fluid Retention
  • Aspiration
  • Hypotension
  • Nausea
  • Pain
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as suicide attempt, may become evident only after a product is in use by the general population.

Retching, Vomiting, Weight Decreased, Blood Magnesium Decreased, Headache
This is a Nucynta Er side effect report of a male patient (weight: NA) from US. The patient developed the following symptoms/conditions: headache and was treated with Nucynta Er (dosage: 50 Mg As Needed Twice Daily (started End Of Jun And Begining Of Jul-2013)) starting 2013. Concurrently used drugs: NA. Soon after that, the consumer experienced the following of symptoms:
  • Retching
  • Vomiting
  • Weight Decreased
  • Blood Magnesium Decreased
  • Headache
The patient was hospitalized. This opens a possibility that Nucynta Er could cause retching and that some male patients may be more susceptible.

Gastrooesophageal Reflux Disease, Ligament Injury, Depression, Weight Decreased, Loss Of Employment
A 46-year-old female patient (weight: NA) from US with the following symptoms: abdominal pain started Nucynta treatment (dosage: 50 Mg, Three Times A Day As Needed) on 2011. Soon after starting Nucynta treatment, the consumer experienced several side effects, including:
  • Gastrooesophageal Reflux Disease
  • Ligament Injury
  • Depression
  • Weight Decreased
  • Loss Of Employment
. Concurrently used drugs:
  • Prilosec
  • Prilosec
This finding indicates that some patients can be more vulnerable to developing Nucynta side effects, such as gastrooesophageal reflux disease.

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 (dosage: NA), which was started on Feb 14, 2013. Concurrently used drugs:
  • Nucynta Er
.When starting to take Nucynta Ir the consumer reported symptoms, such as:
  • Loss Of Consciousness
  • Hallucination, Auditory
  • Insomnia
  • Tremor
These side effects may potentially be related to Nucynta Ir.

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 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). The consumer presented with:
  • Sleep Terror
  • Hyperhidrosis
  • Cold Sweat
  • Incoherent
  • Headache
  • Sinus Disorder
which developed 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.

Spinal Column Stenosis, Pain, Headache, Hyperhidrosis, Chills, Abdominal Pain
This report suggests a potential Nucynta Er Spinal Column Stenosis, Pain, Headache, Hyperhidrosis, Chills, Abdominal Pain 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. Soon after starting Nucynta Er the patient began experiencing various side effects, including:
  • Spinal Column Stenosis
  • Pain
  • Headache
  • Hyperhidrosis
  • Chills
  • Abdominal Pain
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.

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 commencing Nucynta Ir, the patient experienced the following unwanted symptoms/side effects:
  • Dissociation
Although 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.

Amnesia, Dyspnoea, Palpitations
This is a report of a 25-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: thoracic outlet syndrome and was treated with Nucynta (dosage: 2 Times A Day) starting 201306. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Amnesia
  • Dyspnoea
  • Palpitations
This opens a possibility that Nucynta treatment could cause the above reactions, including amnesia, and some female subjects may be more susceptible.

Pulmonary Embolism, Hysterectomy, Migraine, Dizziness
A 49-year-old female patient (weight: NA) from US with the following symptoms/conditions: pain started Nucynta treatment (dosage: 50 Mg (25mg) Twice Daily Oral) on May 10, 2013. Soon after starting Nucynta treatment, the subject experienced various side effects, including:
  • Pulmonary Embolism
  • Hysterectomy
  • Migraine
  • Dizziness
Concurrently used drugs:
  • Dilaudid
  • Proventil
  • Combivent
  • Coumadin
  • Enoxaparin
  • Fioricet
  • Lasix
  • Vitamin D
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Nucynta.

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Top 10 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

Top 10 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

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


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    How Effective is Nucynta for You?

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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