Hydrocodone Bitartrate and Ibuprofen Side Effects

Please note - some side effects for Hydrocodone Bitartrate and Ibuprofen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Hydrocodone Bitartrate and Ibuprofen Side Effects - for the Professional

Hydrocodone Bitartrate and Ibuprofen

Hydrocodone Bitartrate and Ibuprofen tablets were administered to approximately 300 pain patients in a safety study that employed dosages and a duration of treatment sufficient to encompass the recommended usage. 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 Hydrocodone Bitartrate and Ibuprofen 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 Hydrocodone Bitartrate and Ibuprofen tablets, 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.

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