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Tramadol and Acetaminophen (Tramadol Hydrochloride / Acetaminophen) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS


Table 2 reports the incidence rate of treatment-emergent adverse events over five days of tramadol hydrochloride and acetaminophen tablets use in clinical trials (subjects took an average of at least 6 tablets per day).

Table 2: Incidence of Treatment-Emergent Adverse Events (≥2%)



Body System
Preferred Term
Tramadol hydrochloride and acetaminophen tablets
(N=142) (%)
Gastrointestinal System Disorders
 
       Constipation
6
       Diarrhea
3
       Nausea
3
       Dry Mouth
2
Central & Peripheral Nervous System  
 
       Somnolence
6
       Anorexia
3
       Insomnia
2
Central & Peripheral Nervous System  
 
       Dizziness
3
Skin and Appendages  
 
       Sweating Increased
4
       Pruritus
2
Reproductive Disorders, Male *  
 
       Prostatic Disorder
2

*Number of males = 62



Incidence at least 1%, causal relationship at least possible or greater: the following lists adverse reactions that occurred with an incidence of at least 1% in single-dose or repeated-dose clinical trials of tramadol hydrochloride and acetaminophen tablets.

Body as a Whole
– Asthenia, fatigue, hot flushes

Central and Peripheral Nervous System
– Dizziness, headache, tremor

Gastrointestinal System
– Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting

Psychiatric Disorders
– Anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence

Skin and Appendages
– Pruritus, rash, increased sweating

Selected Adverse events occurring at less than 1%
: the following lists clinically relevant adverse reactions that occurred with an incidence of less than 1% in tramadol hydrochloride and acetaminophen tablet clinical trials.

Body as a Whole
– Chest pain, rigors, syncope, withdrawal syndrome

Cardiovascular Disorders
– Hypertension, aggravated hypertension, hypotension

Central and Peripheral Nervous System
– Ataxia, convulsions, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, paresthesias, stupor,  vertigo

Gastrointestinal System
– Dysphagia, melena, tongue edema

Hearing and Vestibular Disorders
– Tinnitus

Heart Rate and Rhythm Disorders
– Arrhythmia, palpitation, tachycardia

Liver and Biliary System
– Hepatic function abnormal

Metabolic and Nutritional Disorders
– Weight decrease

Psychiatric Disorders
– Amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, paroniria, abnormal thinking

Red Blood Cell Disorders
– Anemia

Respiratory System
– Dyspnea

Urinary System
– Albuminuria, micturition disorder, oliguria, urinary retention

Vision Disorders
– Abnormal vision

Other clinically significant adverse experiences previously reported with tramadol hydrochloride:

 Other events which have been reported with the use of tramadol products and for which a causal association has not been determined include: vasodilation, orthostatic hypotension, myocardial ischemia, pulmonary edema, allergic reactions (including anaphylaxis and urticaria, Stevens-Johnson syndrome/TENS), cognitive dysfunction, difficulty concentrating, depression, suicidal tendency, hepatitis, liver failure, and gastrointestinal bleeding. Reported laboratory abnormalities included elevated creatinine and liver function tests. Serotonin syndrome (whose symptoms may include mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures, and coma) has been reported with tramadol when used concomitantly with other serotonergic agents such as SSRIs and MAOIs.

Other clinically significant adverse experiences previously reported with acetaminophen:

 Allergic reactions (primarily skin rash) or reports of hypersensitivity secondary to acetaminophen are rare and generally controlled by discontinuation of the drug and, when necessary, symptomatic treatment.

Drug label data at the top of this Page last updated: 2014-10-29

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