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Ultracet (Tramadol Hydrochloride / Acetaminophen) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Table 2 reports the incidence rate of treatment-emergent adverse events over five days of ULTRACET® use in clinical trials (subjects took an average of at least 6 tablets per day).

Table 2: Incidence of Treatment-Emergent Adverse Events (≥2.0%)
Body System
  Preferred Term
ULTRACET® (N=142)
(%)
Gastrointestinal System Disorders
  Constipation 6
  Diarrhea 3
  Nausea 3
  Dry Mouth 2
Psychiatric Disorders
  Somnolence 6
  Anorexia 3
  Insomnia 2
Central & Peripheral Nervous System
  Dizziness 3
Skin and Appendages
  Sweating Increased 4
  Pruritus 2
Reproductive Disorders, Male Number of males = 62
  Prostatic Disorder 2

Incidence at least 1%, causal relationship at least possible or greater: the following lists adverse reactions that occurred with an incidence of at least 1% in single-dose or repeated-dose clinical trials of ULTRACET®.

Body as a Whole – Asthenia, fatigue, hot flushes

Central and Peripheral Nervous System – Dizziness, headache, tremor

Gastrointestinal System – Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting

Psychiatric Disorders – Anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence

Skin and Appendages – Pruritus, rash, increased sweating

Selected Adverse events occurring at less than 1%: the following lists clinically relevant adverse reactions that occurred with an incidence of less than 1% in ULTRACET® clinical trials.

Body as a Whole – Chest pain, rigors, syncope, withdrawal syndrome

Cardiovascular Disorders – Hypertension, aggravated hypertension, hypotension

Central and Peripheral Nervous System – Ataxia, convulsions, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, paresthesias, stupor, vertigo

Gastrointestinal System – Dysphagia, melena, tongue edema

Hearing and Vestibular Disorders – Tinnitus

Heart Rate and Rhythm Disorders – Arrhythmia, palpitation, tachycardia

Liver and Biliary System – Hepatic function abnormal

Metabolic and Nutritional Disorders – Weight decrease

Psychiatric Disorders – Amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, paroniria, abnormal thinking

Red Blood Cell Disorders – Anemia

Respiratory System – Dyspnea

Urinary System – Albuminuria, micturition disorder, oliguria, urinary retention

Vision Disorders – Abnormal vision

Post-marketing experience: The following adverse reactions, not noted above, have been identified during post approval use of tramadol-containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Eye disorders – miosis, mydriasis

Nervous system disorders – movement disorder, speech disorder

Psychiatric disorders – delirium

Other clinically significant adverse experiences previously reported with tramadol hydrochloride:

Other events which have been reported with the use of tramadol products and for which a causal association has not been determined include: vasodilation, orthostatic hypotension, myocardial ischemia, pulmonary edema, allergic reactions (including anaphylaxis and urticaria, Stevens-Johnson syndrome/TENS), cognitive dysfunction, difficulty concentrating, depression, suicidal tendency, hepatitis, liver failure, and gastrointestinal bleeding. Reported laboratory abnormalities included elevated creatinine and liver function tests. Serotonin syndrome (whose symptoms may include mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures, and coma) has been reported with tramadol when used concomitantly with other serotonergic agents such as SSRIs and MAOIs. Cases of hypoglycemia have been reported very rarely in patients taking tramadol. Most reports were in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients.

Other clinically significant adverse experiences previously reported with acetaminophen:

Allergic reactions (primarily skin rash) or reports of hypersensitivity secondary to acetaminophen are rare and generally controlled by discontinuation of the drug and, when necessary, symptomatic treatment.



REPORTS OF SUSPECTED ULTRACET SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Ultracet. The information is not vetted and should not be considered as verified clinical evidence.

Possible Ultracet side effects / adverse reactions in 66 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-14

Patient: 66 year old male

Reactions: Respiratory Failure, Suicide Attempt, Multiple Drug Overdose, Somnolence

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Benzodiazepine NOS
    Indication: Product Used FOR Unknown Indication

Ultracet
    Indication: Product Used FOR Unknown Indication



Possible Ultracet side effects / adverse reactions in 59 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-17

Patient: 59 year old male

Reactions: Blood Bilirubin Increased, Confusional State, Blood Creatine Phosphokinase Increased, Drug Screen Positive, Mental Status Changes, Prothrombin Time Prolonged, Somnolence, Liver Function Test Abnormal, International Normalised Ratio Decreased, Multiple Drug Overdose, Blood Creatinine Increased, Blood Urea Increased, International Normalised Ratio Increased, Alanine Aminotransferase Increased, Toxicity TO Various Agents, Dysarthria, Aspartate Aminotransferase Increased, Ammonia Increased

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Opiates
    Indication: Product Used FOR Unknown Indication

Vicodin
    Indication: Pain

Ultracet
    Indication: Pain

Benzodiazepine NOS
    Indication: Product Used FOR Unknown Indication



Possible Ultracet side effects / adverse reactions in 17 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-17

Patient: 17 year old female

Reactions: Electrocardiogram QT Prolonged, Blood Potassium Decreased, Toxicity TO Various Agents, Multiple Drug Overdose, Respiratory Depression, Sinus Tachycardia, Somnolence

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Ultracet
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-29

Cyclobenzaprine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-29

Acetaminophen
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-05-29

Phencyclidine
    Indication: Product Used FOR Unknown Indication

Opiates
    Indication: Product Used FOR Unknown Indication

Acetaminophen
    Administration route: Oral

Acetaminophen W/ Codeine TAB
    Indication: Product Used FOR Unknown Indication

Methadone HCL
    Indication: Product Used FOR Unknown Indication



See index of all Ultracet side effect reports >>

Drug label data at the top of this Page last updated: 2014-10-12

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