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Ultram (Tramadol Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

ULTRAM® was administered to 550 patients during the double-blind or open-label extension periods in U.S. studies of chronic nonmalignant pain. Of these patients, 375 were 65 years old or older. Table 2 reports the cumulative incidence rate of adverse reactions by 7, 30 and 90 days for the most frequent reactions (5% or more by 7 days). The most frequently reported events were in the central nervous system and gastrointestinal system. Although the reactions listed in the table are felt to be probably related to ULTRAM® administration, the reported rates also include some events that may have been due to underlying disease or concomitant medication. The overall incidence rates of adverse experiences in these trials were similar for ULTRAM® and the active control groups, TYLENOL® with Codeine #3 (acetaminophen 300 mg with codeine phosphate 30 mg), and aspirin 325 mg with codeine phosphate 30 mg, however, the rates of withdrawals due to adverse events appeared to be higher in the ULTRAM® groups.

Table 2: Cumulative Incidence of Adverse Reactions for ULTRAM® in Chronic Trials of Nonmalignant Pain (N=427)
Up to 7 Days Up to 30 Days Up to 90 Days
Dizziness/Vertigo 26% 31% 33%
Nausea 24% 34% 40%
Constipation 24% 38% 46%
Headache 18% 26% 32%
Somnolence 16% 23% 25%
Vomiting 9% 13% 17%
Pruritus 8% 10% 11%
"CNS Stimulation""CNS Stimulation" is a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability and hallucinations 7% 11% 14%
Asthenia 6% 11% 12%
Sweating 6% 7% 9%
Dyspepsia 5% 9% 13%
Dry Mouth 5% 9% 10%
Diarrhea 5% 6% 10%

Incidence 1% to less than 5% possibly causally related: the following lists adverse reactions that occurred with an incidence of 1% to less than 5% in clinical trials, and for which the possibility of a causal relationship with ULTRAM® exists.

Body as a Whole: Malaise.

Cardiovascular: Vasodilation.

Central Nervous System: Anxiety, Confusion, Coordination disturbance, Euphoria, Miosis, Nervousness, Sleep disorder.

Gastrointestinal: Abdominal pain, Anorexia, Flatulence.

Musculoskeletal: Hypertonia.

Skin: Rash.

Special Senses: Visual disturbance.

Urogenital: Menopausal symptoms, Urinary frequency, Urinary retention.

Incidence less than 1%, possibly causally related: the following lists adverse reactions that occurred with an incidence of less than 1% in clinical trials and/or reported in post-marketing experience.

Body as a Whole: Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal tendency, Weight loss, Serotonin syndrome (mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma).

Cardiovascular: Orthostatic hypotension, Syncope, Tachycardia.

Central Nervous System: Abnormal gait, Amnesia, Cognitive dysfunction, Depression, Difficulty in concentration, Hallucinations, Paresthesia, Seizure (see WARNINGS). Tremor.

Respiratory: Dyspnea.

Skin: Stevens-Johnson syndrome/Toxic epidermal necrolysis, Urticaria, Vesicles.

Special Senses: Dysgeusia.

Urogenital: Dysuria, Menstrual disorder.

Other adverse experiences, causal relationship unknown: A variety of other adverse events were reported infrequently in patients taking ULTRAM® during clinical trials and/or reported in post-marketing experience. A causal relationship between ULTRAM® and these events has not been determined. However, the most significant events are listed below as alerting information to the physician.

Cardiovascular: Abnormal ECG, Hypertension, Hypotension, Myocardial ischemia, Palpitations, Pulmonary edema, Pulmonary embolism.

Central Nervous System: Migraine, Speech disorders.

Gastrointestinal: Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure.

Laboratory Abnormalities: Creatinine increase, Elevated liver enzymes, Hemoglobin decrease, Proteinuria.

Sensory: Cataracts, Deafness, Tinnitus.



REPORTS OF SUSPECTED ULTRAM SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Ultram side effects / adverse reactions in 58 year old female

Reported by a consumer/non-health professional from United States on 2011-09-29

Patient: 58 year old female weighing 77.1 kg (169.6 pounds)

Reactions: Dyspnoea, Pruritus, Diabetes Mellitus, Tendon Rupture, Urticaria, Rash, Erythema, Oedema Peripheral, Dizziness, Mental Disorder, Disturbance in Attention, Neuralgia

Suspect drug(s):
Premarin
    Dosage: 0.625 mg ; 0.3 mg ; 0.625 mg
    Indication: Inadequate Lubrication

Etodolac
    Dosage: 200 mg
    Indication: Inflammation
    End date: 2011-07-01

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2009-12-01

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    End date: 2010-07-01

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2011-07-31
    End date: 2011-07-31

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2011-08-02

Lyrica
    Dosage: 300 mg;bid;po ; 50 mg;po ; 100 mg;po ; 150 mg;po ; 200 mg;po
    Administration route: Oral
    Indication: Neuralgia
    Start date: 2011-08-01
    End date: 2011-08-01

Ultram
    Indication: Pain
    End date: 2011-07-01

Advil Liqui-Gels
    Indication: Pain
    End date: 2011-07-30



Possible Ultram side effects / adverse reactions in 38 year old female

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

Patient: 38 year old female

Reactions: Unresponsive TO Stimuli, Hypotension, Tachycardia, Toxicity TO Various Agents, Drug Abuse, Somnolence, Tremor, Convulsion, Loss of Consciousness, Multiple Drug Overdose, Sinus Tachycardia

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Bupropion HCL

Ethanol
    Indication: Product Used FOR Unknown Indication

Bupropion HCL
    Indication: Product Used FOR Unknown Indication

Ultram
    Indication: Product Used FOR Unknown Indication



Possible Ultram side effects / adverse reactions in 15 year old male

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

Patient: 15 year old male

Reactions: Hypotension, Tachycardia, Blood PH Decreased, Oxygen Saturation Abnormal, Abnormal Behaviour, Toxicity TO Various Agents, Respiratory Depression, Somnolence, Convulsion, Abdominal Discomfort, Blood Potassium Decreased, Depressed Level of Consciousness, Multiple Drug Overdose, Bradycardia, Lethargy

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Antibiotic
    Dosage: 5-6 antibiotic, preparation 300 mg
    Indication: Product Used FOR Unknown Indication

Methadone HCL
    Indication: Product Used FOR Unknown Indication

Ultram
    Dosage: 50 mg
    Indication: Product Used FOR Unknown Indication

Cefdinir
    Indication: Product Used FOR Unknown Indication



See index of all Ultram side effect reports >>

Drug label data at the top of this Page last updated: 2012-11-28

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