Chlorpheniramineside effects

The following serious adverse reactions are described, or described in greater detail, in other sections:

Addiction, abuse, and misuse

Life-threatening respiratory depression

Accidental overdose and death due to medication errors

Decreased mental alertness with impaired mental and/or physical abilities

Interactions with benzodiazepines and other CNS depressants

Paralytic ileus, gastrointestinal adverse reactions

Increased intracranial pressure

Obscured clinical course in patients with head injuries

Seizures

Severe hypotension

Neonatal Opioid Withdrawal Syndrome

Adrenal insufficiency The following adverse reactions have been identified during clinical studies, in the literature, or during post-approval use of hydrocodone and/or chlorpheniramine. Because these reactions may be 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. The most common adverse reactions to Hydrocodone Polistirex and Chlorpheniramine Polistirex include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation. Other reactions include: Anaphylaxis: Anaphylaxis has been reported with hydrocodone, one of the ingredients in Hydrocodone Polistirex and Chlorpheniramine Polistirex. Body as a whole: Coma, death, fatigue, falling injuries, lethargy. Cardiovascular: Peripheral edema, increased blood pressure, decreased blood pressure, tachycardia, chest pain, palpitation, syncope, orthostatic hypotension, prolonged QT interval, hot flush. Central Nervous System: Ataxia, facial dyskinesia, insomnia, migraine, increased intracranial pressure, seizure, tremor, tinnitus, vertigo. Dermatologic: Flushing, hyperhidrosis, pruritus, rash. Endocrine/Metabolic: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs. Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use. Cases of androgen deficiency have occurred with chronic use of opioids. Gastrointestinal: Abdominal pain, bowel obstruction, decreased appetite, diarrhea, difficulty swallowing, GERD, indigestion, pancreatitis, paralytic ileus, biliary tract spasm (spasm of the sphincter of Oddi). Genitourinary: Urinary tract infection, ureteral spasm, spasm of vesicle sphincters, urinary retention. Hematologic: Agranulocytosis, aplastic anemia, and thrombocytopenia have been reported. Laboratory: Increases in serum amylase. Musculoskeletal: Arthralgia, backache, muscle spasm. Ophthalmic: Blurred vision, diplopia, miosis (constricted pupils), visual disturbances. Psychiatric: Agitation, anxiety, confusion, fear, dysphoria, depression, hallucinations. Reproductive: Hypogonadism, infertility. Respiratory: Bronchitis, cough, dyspnea, nasal congestion, nasopharyngitis, respiratory depression, sinusitis, upper respiratory tract infection, thickening of bronchial secretions, tightness of chest and wheezing, dry nose, dry throat. Other: Drug abuse, drug dependence, opioid withdrawal syndrome. Common adverse reactions include: Sedation (somnolence, mental clouding, lethargy), impaired mental and physical performance, lightheadedness, dizziness, headache, dry mouth, nausea, vomiting, and constipation To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at 1-732-940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.