ADVERSE REACTIONS
Adverse reactions listed below have been reported in the literature for codeine and chlorpheniramine and may be expected to occur with Codeprex. Also included are events which occurred during clinical pharmacokinetic studies (in a total of 147 healthy adult volunteers with either single or multiple dose exposure) with Codeprex and judged by the investigator to be related to study treatment. There are insufficient data to support a statement regarding distribution of adverse events by gender, race and age (see PRECAUTIONS: Pediatric Use and PRECAUTIONS: Geriatric Use).
Body as a Whole
Asthenia, feeling of relaxation, redness or flushing of the face, unusual tiredness or weakness.
Allergic
Allergic laryngospasm, atelectasis, bronchospastic allergic reaction, hives, itching, swelling of face.
Cardiovascular
Fast, slow, or pounding heartbeat, hypertension, hypotension, orthostatic hypotension, palpitation, shock-like state, syncope.
Dermatologic System
Dermatitis, excessive perspiration, urticaria, erythema, pruritus, rash.
Endocrine
Changes in glucose utilization, decreased lactation, early menses, glycosuria, gynecomastia, hypoglycemia, increased appetite, increased libido, pheochromocytoma stimulation.
Gastrointestinal
Abdominal distension, abdominal pain, acute pancreatitis, constipation, diarrhea, dry mouth, dyspepsia, epigastric distress, loss of appetite, nausea, vomiting; also observed with opioids: decreased gastric motility with increased likelihood of esophageal reflux.
Genitourinary
Dysuria, irritative bladder symptoms, urinary frequency, urinary hesitancy, urinary retention, ureteral spasm.
Nervous System
Blurred, double, or other visual disturbances; confusion; dizziness; depression; drowsiness and sedation; headache; euphoria; facial dyskinesia; false sense of well-being; feeling faint, lightheadedness, general feeling of discomfort or illness; may cause excitability, especially in children; nervousness, agitation and restlessness; minimal sedation; somnolence; also observed with antihistamine agents: insomnia, dyskinesia, irritability, tremor.
Respiratory System
Dryness of pharynx and respiratory passages, laryngismus, nasal stuffiness, wheezing or troubled breathing, respiratory depression.
Special Senses
Ears: labyrinthitis, tinnitus, vertigo; eyes: blurred vision, diplopia, hypermetropia, lacrimation increased, mydriasis, photophobia.
Other
Drug fever.
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