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Reprexain

Last reviewed on RxList: 2/2/2017
Reprexain Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 02/02/2017

Reprexain (hydrocodone bitartrate and ibuprofen tablets) is a combination of an opioid analgesic and a nonsteroidal anti-inflammatory drug (NSAID) indicated for the short-term (generally less than 10 days) management of acute pain. Reprexain is not indicated for the treatment of such conditions as osteoarthritis or rheumatoid arthritis. Reprexain is available in generic form. Common side effects of Reprexain include:

  • headache,
  • dizziness,
  • drowsiness,
  • constipation,
  • shortness of breath,
  • nausea,
  • abdominal pain,
  • weakness,
  • infection,
  • anxiety,
  • insomnia,
  • nervousness,
  • diarrhea,
  • dry mouth,
  • gas,
  • vomiting,
  • swelling,
  • itching, and
  • sweating.

For the short-term (generally less than 10 days) management of acute pain, the recommended dose of Reprexain is one tablet every 4 to 6 hours, as necessary. Dosage should not exceed 5 tablets in a 24-hour period. Reprexain may interact with of ACE-inhibitors, anticholinergics, monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, aspirin, other opioids, antihistamines, antipsychotics, antianxiety agents, other CNS depressants (including alcohol), diuretics, lithium, methotrexate, pentazocine, nalbuphine, butorphanol, buprenorphine, skeletal muscle relaxants, and warfarin. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Reprexain; it should be avoided late in pregnancy because it may cause birth defects. It is unknown if the drugs in Reprexain pass into breast milk. Because of the potential for adverse effects on a nursing infant, breastfeeding while using Reprexain is not recommended. Withdrawal symptoms may occur if you suddenly stop taking Reprexain.

Our Reprexain (hydrocodone bitartrate and ibuprofen tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Reprexain Professional Information

SIDE EFFECTS

REPREXAIN™ 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 REPREXAIN™ 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 REPREXAIN™, 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.

Read the entire FDA prescribing information for Reprexain (hydrocodone bitartrate and ibuprofen)

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