Tramadol Hydrochloride And Acetaminophen Side Effects

6 ADVERSE REACTIONS The following serious adverse reactions are discussed, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children [see Warnings and Precautions (5.6) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.9) ] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3) ] Opioid-Induced Hyperalgesia and Allodynia [See Warnings and Precautions (5.8) ] Serotonin Syndrome [see Warnings and Precautions (5.10) ] Seizures [see Warnings and Precautions (5.11) ] Suicide [see Warnings and Precautions (5.12) ] Adrenal Insufficiency [see Warnings and Precautions (5.14) ] Severe Hypotension [see Warnings and Precautions (5.15) ] Gastrointestinal Adverse Reactions [see Warnings and Precautions (5.18) ] Hypersensitivity Reactions [see Warnings and Precautions (5.19) ] Withdrawal [see Warnings and Precautions (5.21) ] The most common incidence of treatment-emergent adverse events (≥3.0%) in patients from clinical trials were constipation, diarrhea, nausea, somnolence, anorexia, dizziness, and sweating increased.

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.

at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common incidence of treatment-emergent adverse events (≥3.0%) in subjects from clinical trials was constipation, diarrhea, nausea, somnolence, anorexia, dizziness, and sweating increased.

Table 1 shows the incidence rate of treatment-emergent adverse events reported in ≥2.0% of subjects over five days of tramadol hydrochloride and acetaminophen use in clinical trials (subjects took an average of at least 6 tablets per day).

Table 1: Incidence of Treatment-Emergent Adverse Events (≥2.0%) Body System Preferred Term Tramadol Hydrochloride and Acetaminophen (N=142) (%) Gastrointestinal System Disorders Constipation Diarrhea Nausea Dry Mouth Psychiatric Disorders Somnolence Anorexia Insomnia Central & Peripheral Nervous System Dizziness Skin and Appendages Sweating Increased Pruritus Reproductive Disorders, Male* Prostatic Disorder 6 3 3 2 6 3 2 3 4 2 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.

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 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 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of tramadol-containing products.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.