Tramadol (Tramadol Hydrochloride) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Tramadol hydrochloride tablets were 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 tramadol hydrochloride tablets 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 tramadol hydrochloride tablets 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 tramadol hydrochloride groups. [TYLENOL^® is the registered trademark of McNeil Consumer Healthcare and TYLOX^® is the registered trademark of RW Johnson].

Table 2 Cumulative Incidence of Adverse Reactions for Tramadol Hydrochloride Tablets in Chronic Trials of Nonmalignant Pain (N=427)

	Up to 7 Days	Up to 30 Days	Up to 90 Days
1 “CNS Stimulation” is a composite of nervousness, anxiety, agitation, tremor, spasticity, euphoria, emotional lability and hallucinations.
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” 1	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 tramadol hydrochloride tablets 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 tramadol hydrochloride tablets during clinical trials and/or reported in post-marketing experience. A causal relationship between tramadol hydrochloride tablets 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 TRAMADOL SIDE EFFECTS / ADVERSE REACTIONS

Possible Tramadol side effects / adverse reactions in 24 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-03-29

Patient: 24 year old male

Reactions: Jaundice, Autoimmune Hepatitis

Adverse event resulted in: hospitalization

Suspect drug(s):
Lyrica
    Dosage: unk
    Administration route: Oral
    Indication: Back Pain
    Start date: 2011-01-01

Tetrazepam
    Dosage: unk
    Administration route: Oral
    Indication: Back Pain
    Start date: 2011-01-01

Tramadol
    Dosage: unk
    Administration route: Oral
    Indication: Back Pain
    Start date: 2011-01-01

Possible Tramadol side effects / adverse reactions in 58 year old male

Reported by a physician from Netherlands on 2012-04-16

Patient: 58 year old male weighing 80.0 kg (176.0 pounds)

Reactions: LIP Swelling, Malaise, Dyspnoea, Urticaria

Adverse event resulted in: hospitalization

Suspect drug(s):
Arthrotec
    Dosage: 75 mg, 1x/day
    Administration route: Oral
    Indication: Myalgia
    Start date: 2011-01-01
    End date: 2012-03-03

Pantoprazole
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Dyspepsia
    Start date: 2011-01-01

Tamsulosin Hydrochloride
    Dosage: 0.4 mg, 1x/day
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2011-01-01

Tramadol
    Dosage: 50 mg, 1x/day
    Administration route: Oral
    Indication: Myalgia
    Start date: 2011-01-01
    End date: 2012-02-01

Possible Tramadol side effects / adverse reactions in 46 year old male

Reported by a physician from Korea, Republic of on 2012-04-27

Patient: 46 year old male

Reactions: Dysarthria, Pneumonia Aspiration, Sedation, Respiratory Depression

Suspect drug(s):
Morphine Sulfate
    Dosage: concentration of 28mg/ml,basal rate of 0.5 ml/h
    Indication: Pain

Tramadol
    Dosage: 50 mg, unk
    Indication: Pain