Reprexain Side Effects

Please note - some side effects for Reprexain may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Reprexain - for the Consumer

Reprexain

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Reprexain:

Anxiety; constipation; diarrhea; dizziness; dry mouth; gas; headache; heartburn; increased sweating; loss of appetite; nausea; nervousness; stomach pain or upset; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; blurred vision; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; slow or shallow breathing; stiff neck; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Reprexain Side Effects - for the Professional

Reprexain

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. 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.

Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects of hydrocodone have included mental depression, dizziness, lightheadedness, respiratory depression (which is sometimes fatal), stupor, delirium, somnolence, agitation, and dysphoria.

Central nervous system side effects of ibuprofen including headache, drowsiness, and dizziness have been reported rarely. Aseptic meningitis associated with ibuprofen has been described in several case reports. In addition, paresthesias and pseudotumor cerebri have been reported, although causality is unknown.

One study has suggested that the respiratory depression caused by hydrocodone may be of benefit in the treatment of dyspnea related to chronic obstructive pulmonary disease and restrictive lung disease. However, the potential for the precipitation of respiratory insufficiency makes such use of hydrocodone hazardous and such use should be undertaken, if at all, only with extreme caution.

The incidence of aseptic meningitis associated with ibuprofen is higher in patients with systemic lupus erythematosus and other connective tissue diseases although it has been reported in patients without such underlying disease states.

Other

Other side effects reported with ibuprofen have included tinnitus (1% to 3%) and vertigo.

Like other narcotic analgesics, hydrocodone may be habit forming. Withdrawal symptoms after either abrupt cessation or fast tapering of narcotic analgesics may occur. Such symptoms may include agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, blurred vision, vomiting and sweating.

Gastrointestinal

The incidence of gastrointestinal blood loss with ibuprofen is dose-related, occurring in up to 17% of patients receiving 1,600 mg per day and in 23% of patients receiving 2,400 mg of ibuprofen per day.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Ibuprofen should be used with caution in these patients.

Gastrointestinal side effects of ibuprofen have usually been mild and transient, and have included dyspepsia, nausea, diarrhea, abdominal pain, and flatulence. More serious gastrointestinal effects are uncommon but include occult blood loss, ulcer, gastrointestinal hemorrhage with or without perforation, and pancreatitis. In addition, small bowel enteropathies and ibuprofen-associated colitis have been reported. Bloody vomiting has occurred in overdose. Colonic and pyloric channel strictures have also been reported.

Nausea, vomiting, constipation, and dry mouth are relatively common effects of narcotic analgesics.

Genitourinary

Genitourinary side effects including ureteral spasm, spasm of vesicle sphincters, and urinary retention have been reported with the use of hydrocodone.

Dermatologic

Dermatologic side effects have been uncommon with the use of ibuprofen. They have included maculopapular rash, pruritus, vesiculobullous eruptions, erythema multiforme, vasculitis, Stevens-Johnson syndrome, and alopecia. Toxic epidermal necrolysis as well as photosensitivity reactions are reported as well, although causality is unknown.

Narcotic-induced rashes have been reported.

Hepatic

Elevations in liver function tests three times normal values occur in less than 1% of patients. Ibuprofen-induced hepatitis has been associated with a fatal outcome in some cases.

Vanishing bile duct syndrome has been associated with ibuprofen use. A 29-year-old male patient presented with right upper quadrant pain, jaundice, pruritus and dark urine. He had been taking ibuprofen 600 mg/day for body aches and tension related headaches three weeks prior to the onset of symptoms. The patient remained jaundiced, with xanthomatosis, and complained of fatigue and pruritus 12 months following ibuprofen ingestion. He was eventually referred to an institution for liver transplantation evaluation. The patient was diagnosed with vanishing bile duct syndrome attributed to ibuprofen use.

Hepatic side effects including elevations in liver function tests, jaundice, hepatitis, liver necrosis, and hepatic failure (some of them with fatal outcomes) have been reported.

Renal

Ibuprofen may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for ibuprofen-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-controlled study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Renal side effects of ibuprofen have included mild renal insufficiency as well as nephrotic syndrome with and without renal failure, and acute renal failure due to tubulointerstitial nephritis, papillary necrosis, and acute tubular necrosis.

Metabolic

Metabolic side effects from ibuprofen have included hyponatremia and syndrome of inappropriate antidiuretic hormone (SIADH). In addition, gynecomastia, hypoglycemia, and acidosis have been reported, although causality is unknown. Hyperkalemia has occurred in overdose.

Cardiovascular

A rare case of painful, persistent peripheral cyanosis and swelling of the fingers and toes which progressed to desquamation and digital pitting infarctions has been associated with ibuprofen.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Cardiovascular side effects of ibuprofen have included peripheral edema (1% to 3%) and elevated blood pressure (< 1%). This may be important in some patients with preexisting hypertension or congestive heart failure.

Hypersensitivity

Hypersensitivity side effect of ibuprofen have included erythematous or urticarial rashes, pruritus, angioedema, bronchospasm, and anaphylactoid reactions, particularly in patients with the syndrome of asthma, nasal polyps, and angioedema and/or bronchospastic reactivity to aspirin. Rare cases of systemic reactions, including interstitial nephritis and diffuse pulmonary infiltrates, have also been reported.

Hematologic

Hematologic side effects of ibuprofen have included platelet dysfunction, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, eosinophilia, and decreases in hemoglobin and hematocrit.

Reductions in serum hemoglobin concentrations are uncommon and are usually associated with occult gastrointestinal blood loss. Rare cases of ibuprofen-associated hemolytic anemia, autoimmune thrombocytopenia, and leukopenia have been reported.

Respiratory

Acute noncardiogenic pulmonary edema developed on two occasions in an HIV-positive patient. Infectious as well as cardiac etiologies were excluded. A close temporal relationship with the administration of ibuprofen and onset of symptoms was noted.

Respiratory side effects including noncardiogenic pulmonary edema associated with ibuprofen therapy has been reported.

Ocular

Ocular side effects from the use of ibuprofen have included blurred vision (<1%), scotomata, and diplopia. In addition, at least one case of corneal verticillata has been reported.

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