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.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ULTRAM
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 cosidered as verified clinical evidence.
Possible Ultram side effects / adverse reactions in 57 year old female
Reported by a consumer/non-health professional from United States on 2007-02-22
Patient: 57 year old female weighing 70.3 kg (154.7 pounds)
Reactions: Pruritus Generalised, NO Therapeutic Response
Suspect drug(s):
Ultram
Possible Ultram side effects / adverse reactions in 41 year old female
Reported by a pharmacist from United States on 2007-03-02
Patient: 41 year old female weighing 41.0 kg (90.2 pounds)
Reactions: Pneumonia Aspiration, Incorrect Dose Administered, Atrial Fibrillation, Mental Status Changes, Convulsion
Adverse event resulted in: hospitalization
Suspect drug(s):
Ultram
Dosage: 1-2 -50mg- tablets q4-6 prn pain po (duration 1x; all at once)
Administration route: Oral
Indication: Pain
Wellbutrin
Dosage: po (duration: 1x; not patient's med)
Administration route: Oral
Indication: Self-Medication
Other drugs received by patient: Tramadol HCL; Fluoxetine
Possible Ultram side effects / adverse reactions in 49 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2007-03-07
Patient: 49 year old female
Reactions: Rash
Suspect drug(s):
Ultram
Dosage: 50mg 3 qid po
Administration route: Oral
Indication: Fibromyalgia
Start date: 2003-06-01
End date: 2003-09-01
Ultram
Dosage: 50mg 3 qid po
Administration route: Oral
Indication: Synovitis
Start date: 2003-06-01
End date: 2003-09-01
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