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 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
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