openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 2 matching rows.
adverse reactions
ADVERSE REACTIONS The safety of Oxycodone HCl Controlled-Release Tablets was evaluated in double-blind clinical trials involving 713 patients with moderate to severe pain of various etiologies. In open-label studies of cancer pain, 187 patients received Oxycodone HCl Controlled-Release Tablets in total daily doses ranging from 20 mg to 640 mg per day. The average total daily dose was approximately 105 mg per day. Serious adverse reactions which may be associated with Oxycodone HCl Controlled-Release Tablet therapy in clinical use are those observed with other opioid analgesics, including respiratory depression, apnea, respiratory arrest, and (to an even lesser degree) circulatory depression, hypotension, or shock (see OVERDOSAGE ). The non-serious adverse events seen on initiation of therapy with Oxycodone HCl Controlled-Release Tablets are typical opioid side effects. These events are dose-dependent, and their frequency depends upon the dose, the clinical setting, the patient’s level of opioid tolerance, and host factors specific to the individual. They should be expected and managed as a part of opioid analgesia. The most frequent (>5%) include: constipation, nausea, somnolence, dizziness, vomiting, pruritus, headache, dry mouth, sweating, and asthenia. In many cases the frequency of these events during initiation of therapy may be minimized by careful individualization of starting dosage, slow titration, and the avoidance of large swings in the plasma concentrations of the opioid. Many of these adverse events will cease or decrease in intensity as Oxycodone HCl Controlled-Release Tablet therapy is continued and some degree of tolerance is developed. Clinical trials comparing Oxycodone HCl Controlled-Release Tablets with immediate-release oxycodone and placebo revealed a similar adverse event profile between Oxycodone HCl Controlled-Release Tablets and immediate-release oxycodone. The most common adverse events (>5%) reported by patients at least once during therapy were: Table 3 Oxycodone Hydrochloride Extended-Release Immediate-Release Placebo (n=227) (n=225) (n=45) (%) (%) (%) Constipation (23) (26) (7) Nausea (23) (27) (11) Somnolence (23) (24) (4) Dizziness (13) (16) (9) Pruritus (13) (12) (2) Vomiting (12) (14) (7) Headache (7) (8) (7) Dry Mouth (6) (7) (2) Asthenia (6) (7) - Sweating (5) (6) (2) The following adverse experiences were reported in Oxycodone HCl Controlled-Release Tablets-treated patients with an incidence between 1% and 5%. In descending order of frequency they were anorexia, nervousness, insomnia, fever, confusion, diarrhea, abdominal pain, dyspepsia, rash, anxiety, euphoria, dyspnea, postural hypotension, chills, twitching, gastritis, abnormal dreams, thought abnormalities, and hiccups. The following adverse reactions occurred in less than 1% of patients involved in clinical trials or were reported in postmarketing experience. Blood and lymphatic system disorders: lymphadenopathy Cardiac disorders: palpitations (in the context of withdrawal) Ear and labyrinth disorders: tinnitus Endocrine disorders: syndrome of inappropriate antidiuretic hormone secretion (SIADH) Eye disorders: abnormal vision Gastrointestinal disorders: dysphagia, eructation, flatulence, gastrointestinal disorder, ileus, increased appetite, stomatitis General disorders and administration site conditions: chest pain, edema, facial edema, malaise, pain, peripheral edema, thirst, withdrawal syndrome (with and without seizures) Immune system disorders: anaphylactic or anaphylactoid reaction (symptoms of) Infections and infestations: pharyngitis Injury, poisoning and procedural complications: accidental injury Investigations: hyponatremia, increased hepatic enzymes, ST depression Metabolism and nutrition disorders: dehydration Musculoskeletal and connective tissue disorders: neck pain Nervous system disorders: abnormal gait, amnesia, hyperkinesia, hypertonia (muscular), hypesthesia, hypotonia, migraine, paresthesia, seizures, speech disorder, stupor, syncope, taste perversion, tremor, vertigo Psychiatric disorders: agitation, depersonalization, depression, emotional lability, hallucination Renal and urinary disorders: dysuria, hematuria, polyuria, urinary retention, urination impaired Reproductive system and breast disorders: amenorrhea, decreased libido, impotence Respiratory, thoracic and mediastinal disorders: cough increased, voice alteration Skin and subcutaneous tissue disorders: dry skin, exfoliative dermatitis, urticaria Vascular disorders: vasodilation