ADVERSE REACTIONS
VICOPROFEN was administered to approximately 300 pain patients in a safety study that employed dosages and a duration of treatment sufficient to encompass the recommended usage (see DOSAGE AND ADMINISTRATION). Adverse event rates generally increased with increasing daily dose. The event rates reported below are from approximately 150 patients who were in a group that received one tablet of VICOPROFEN an average of three to four times daily. The overall incidence rates of adverse experiences in the trials were fairly similar for this patient group and those who received the comparison treatment, acetaminophen 600 mg with codeine 60 mg.
The following lists adverse events that occurred with an incidence of 1% or greater in clinical trials of VICOPROFEN, without regard to the causal relationship of the events to the drug. To distinguish different rates of occurrence in clinical studies, the adverse events are listed as follows:
name of adverse event = less than 3%
adverse events marked with an asterisk * = 3% to 9%
adverse event rates over 9% are in parentheses.
Body as a Whole
Abdominal pain*; Asthenia*; Fever; Flu syndrome; Headache (27%); Infection*; Pain.
Cardiovascular
Palpitations; Vasodilation.
Central Nervous System
Anxiety*; Confusion; Dizziness (14%); Hypertonia; Insomnia*; Nervousness*; Paresthesia; Somnolence (22%); Thinking abnormalities.
Digestive
Anorexia; Constipation (22%); Diarrhea*; Dry mouth*; Dyspepsia (12%); Flatulence*; Gastritis; Melena; Mouth ulcers; Nausea (21%); Thirst; Vomiting*.
Metabolic and Nutritional Disorders
Edema*.
Respiratory
Dyspnea; Hiccups; Pharyngitis; Rhinitis.
Skin and Appendages
Pruritus*; Sweating*.
Special Senses
Tinnitus.
Urogenital
Urinary frequency.
Incidence less than 1%
Body as a Whole
Allergic reaction.
Cardiovascular
Arrhythmia; Hypotension; Tachycardia.
Central Nervous System
Agitation; Abnormal dreams; Decreased libido; Depression; Euphoria; Mood changes; Neuralgia; Slurred speech; Tremor, Vertigo.
Digestive
Chalky stool; "Clenching teeth"; Dysphagia; Esophageal spasm; Esophagitis; Gastroenteritis; Glossitis; Liver enzyme elevation.
Metabolic and Nutritional
Weight decrease.
Musculoskeletal
Arthralgia; Myalgia.
Respiratory
Asthma; Bronchitis; Hoarseness; Increased cough; Pulmonary congestion; Pneumonia; Shallow breathing; Sinusitis.
Skin and Appendages
Rash; Urticaria.
Special Senses
Altered vision; Bad taste; Dry eyes.
Urogenital
Cystitis; Glycosuria; Impotence; Urinary incontinence; Urinary retention.
DRUG ABUSE AND DEPENDENCE
Controlled Substance
VICOPROFEN Tablets are a Schedule III controlled substance.
Abuse
Psychic dependence, physical dependence, and tolerance may develop upon repeated administration of opioids; therefore, VICOPROFEN Tablets should be prescribed and administered with the same degree of caution appropriate to use of other oral narcotic medications.
Dependence
Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued opioid use, although a mild degree of physical dependence may develop after a few days of opioid therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients. However, psychic dependence is unlikely to develop when VICOPROFEN Tablets are used for a short time for the treatment of acute pain.
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