Tramadol Adverse Reactions, Tramadol Abuse and Dependence

usahealthstore — Wed, 25 Nov 2009 04:11:59 +0000

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 1 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. (TABLE 1)

Table 1 – Tramadol HCl, Adverse Reactions

Cumulative Incidence of Adverse Reactions for Ultram (tramadol HCl)

In Chronic Trials of Nonmalignant Pain

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Up to 7 Days Up to 30 Days Up to 90 Days

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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” 7% 11% 14%

Asthenia 6% 11% 12%

Sweating 6% 7% 9%

Dyspepsia 5% 9% 13%

Dry Mouth 5% 9% 10%

Diarrhea 5% 6% 10%

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1 “CNS Stimulation” is a composite of nervousness, anxiety, agitation,

tremor, spasticity, euphoria, emotional lability and hallucinations.

Incidence less than 5% possibly casually related: TABLE 2 lists adverse reactions that occurred with an incidence of less than 5% in clinical trials, and for which the possibility of a casual relationship with Ultram exists. Reactions are separated according to whether the incidence was greater than 1%. (TABLE 2)

Table 2 – Tramadol HCl, Adverse Reactions

Possibly Ultram Related Adverse Reactions

with an Incidence of Less Than 5%

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Incidence of Adverse Reaction

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Body System From 1% to <5% Less Than 1%

———————————————————————–

Body as a Whole Malaise Allergic reaction;

Accidental injury;

Weight loss

Cardiovascular Vasodilation Syncope; Orthostatic

hypotension; Tachycardia

Central Nervous System Anxiety; Confusion; Seizure (see WARNINGS);

Coordination Paresthesia; Cognitive

disturbance; dysfunction;

Euphoria; Nervous- Hallucinations; Tremor;

ness; Sleep dis- Amnesia; Difficulty in

order concentration; Abnormal

gait

Gastrointestinal Abdominal pain;

Anorexia; Flatulence

Musculoskeletal Hypertonia

Respiratory Dyspnea

Skin Rash Urticaria, Vesicles

Special Senses Visual disturbance Dysgeusia

Urogenital Urinary retention; Dysuria; Menstrual dis-

Urinary frequency; order

Menopausal symptoms

Other adverse experiences, casual relationship undetermined: A variety of other adverse events were reported infrequently in patients taking Ultram during clinical trials. A casual relationship between Ultram and these events has not been determined. However, the most significant events are listed below as alerting information to the physician.

Body as a whole: Suicidal tendency.

Cardiovascular: Abnormal ECG, hypertension, myocardial ischemia, palpitations.

Central Nervous System: Migraine

Gastrointestinal: Gastrointestinal bleeding, hepatitis, stomatitis.

Laboratory abnormalities: Creatinine increase, elevated liver enzymes, hemoglobin decrease, proteinuria.

Sensory: Cataracts, deafness, tinnitus.

DRUG ABUSE AND DEPENDENCE
Although tramadol can produce drug dependence of the µ-opioid type (like codeine or dextropropoxyphene) and potentially may be abused, there has been little evidence of abuse in foreign clinical experience. In clinical trials, tramadol produced effects similar to an opioid, and at supratherapeutic doses was recognized as an opioid in subjective/behavioral studies. Tolerance development has been reported to be relatively mild and withdrawal when present, is not considered to be as severe as that produced by other opioids. Part of tramadol’s activity and some extension of the duration of µ-opioid activity. Delayed µ-opioid activity is believed to reduce a drug’s abuse liability.

An assay for tramadol is not included in routine urine screens for drugs of abuse.

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Tramadol Adverse Reactions, Tramadol Abuse and Dependence