Reprexain Side Effects
Generic name: hydrocodone / ibuprofen
Medically reviewed by Drugs.com. Last updated on May 9, 2024.
Note: This document provides detailed information about Reprexain Side Effects associated with hydrocodone / ibuprofen. Some dosage forms listed on this page may not apply specifically to the brand name Reprexain.
Applies to hydrocodone / ibuprofen: oral tablet.
Important warnings
This medicine can cause some serious health issues
Common side effects of Reprexain
Some side effects of hydrocodone / ibuprofen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- anxiety
- constipation
- dry mouth
- gas
- increased sweating
- nervousness
- pounding heartbeat
- sleepiness
- trouble in sleeping
Rare side effects
- decreased appetite
- decrease in sexual ability
- headache
- heartburn
- increased thirst
- irritability
- mood or mental changes
- mouth ulcers
- pain or burning in the throat
- runny nose
- sensation of burning, warmth, heat, numbness, tightness, or tingling
- slurred speech
- stomach upset
- thinking abnormalities
- unexplained weight loss
- unusual feeling of well-being
Serious side effects of Reprexain
Along with its needed effects, hydrocodone / ibuprofen may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking hydrocodone / ibuprofen:
Rare side effects
- bloody stools
- burning feeling in the chest or stomach
- changes in facial skin color
- cough
- diarrhea
- difficulty with swallowing
- fast or irregular breathing
- fever
- frequent urge to urinate
- heartburn
- inability to urinate
- irregular heartbeat
- lightheadedness or dizziness
- loss of bladder control
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- ringing or buzzing in the ears
- tightness in the chest
- trouble breathing
- skin rash, hives, or itching
- stomach pain
- tenderness in the stomach
- visual disturbances
- yellow eyes or skin
Incidence not known
- agitation
- confusion
- darkening of the skin
- difficulty swallowing
- dizziness
- fainting
- fever
- loss of appetite
- mental depression
- nausea
- overactive reflexes
- poor coordination
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- restlessness
- shivering
- talking or acting with excitement you cannot control
- trembling or shaking
- twitching
- unusual tiredness or weakness
- vomiting
Get emergency help immediately if any of the following symptoms of overdose occur while taking hydrocodone / ibuprofen:
Symptoms of overdose
- blurred vision
- cold or clammy skin
- confusion
- difficulty hearing or ringing or buzzing in the ears
- dizziness
- general feeling of illness
- headache
- mood or mental changes
- nausea
- severe drowsiness
- severe stomach pain
- skin rash
- slow heartbeat
- stiff neck or back
- swelling of the face, fingers, feet, or lower legs
- vomiting
For healthcare professionals
Applies to hydrocodone / ibuprofen: oral tablet.
General adverse events
The more commonly reported adverse reactions have included headache, dizziness, constipation, and dyspepsia.[Ref]
Respiratory
- Frequency not reported: Dyspnea, hiccups, pharyngitis, rhinitis, asthma, bronchitis, hoarseness, increased cough, pulmonary congestion, pneumonia, shallow breathing, sinusitis
Dyspnea, hiccups, pharyngitis, and rhinitis have been reported in less than 3% of patients; asthma, bronchitis, hoarseness, increased cough, pulmonary congestion, pneumonia, shallow breathing, and sinusitis in less than 1%.
Gastrointestinal
- Very common (10% or more): Constipation (22%), dyspepsia (12%), nausea (21%)
- Common (1% to 10%): Abdominal pain, diarrhea, dry mouth, flatulence, vomiting
- Frequency not reported: Anorexia, gastritis, melena, mouth ulcers, thirst, chalky stool, clenching teeth, dysphagia, esophageal spasm, esophagitis, gastroenteritis, glossitis
NSAID:
- Common (1% to 10%): Serious upper GI events
Serious gastrointestinal events including upper GI ulcers, gross bleeding, or perforation attributed to NSAID use have occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for 1 year.
Cardiovascular
- Common (1% to 10%): Palpitations, vasodilation, edema
- Frequency not reported: Arrhythmia, hypotension, tachycardia
NSAIDs:
- Common (1% to 10%): Peripheral edema
- Uncommon (0.1% to 1%): Hypertension
- Frequency not reported: Cardiovascular thrombotic events, myocardial infarction, reinfarction
Arrhythmia, hypotension, and tachycardia have been reported in less than 1% of patients.
NSAID use in post-MI patients has been shown to increase the risk of reinfarction, CV-related death, and all-cause mortality beginning the first week of treatment. NSAID use in the first 10 to 14 days following CABG surgery demonstrated an increased incidence of MI and stroke; NSAIDs are contraindicated in the setting of CABG.
Dermatologic
- Common (1% to 10%): Pruritus, sweating
- Frequency not reported: Rash, urticaria
NSAIDs:
- Frequency not reported: Exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis
Hypersensitivity
- Frequency not reported: Allergic reaction
Hydrocodone:
- Postmarketing reports: Anaphylaxis
Ibuprofen:
- Postmarketing reports: Anaphylaxis
Nervous system
- Very common (10% or more): Headache (27%), dizziness (14%)
- Frequency not reported: Hypertonia, paresthesia, somnolence, neuralgia, slurred speech, tremor, bad taste
Opioids:
- Postmarketing reports: Serotonin syndrome
NSAIDs:
- Rare (less than 0.1%): Aseptic meningitis
Hypertonia, paresthesia, and somnolence have been reported in less than 3% of patients; neuralgia, bad taste, slurred speech, and tremor in less than 1% of patients.
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.
Hepatic
NSAIDs:
- Very common (10% or more): Transaminase elevations less than 3 times the upper limit of normal (3 x ULN) (15%)
- Common (1% to 10%): Transaminase elevations greater than 3 x ULN
- Rare (less than 0.1%): Severe hepatic injury including fulminant hepatitis, liver necrosis, and hepatic failure
Elevations in liver function tests 3 x ULN occurred in less than 1% of patients.
Renal
NSAIDs:
- Frequency not reported: Mild renal insufficiency as well as nephrotic syndrome with and without renal failure, acute renal failure due to tubulointerstitial nephritis, papillary necrosis, and acute tubular necrosis
Metabolic
- Frequency not reported: Decrease weight
NSAIDs:
- Frequency not reported: Hyperkalemia
Psychiatric
- Common (1% to 10%): Anxiety, insomnia, nervousness
- Frequency not reported: Confusion, abnormal thinking, agitation, abnormal dream, decreased libido, depression, euphoria, mood changes
Postmarketing reports:
Confusion and abnormal thinking have been reported in less than 3% of patients; agitation, abnormal dream, decreased libido, depression, euphoria, and mood changes in less than 1%.
Other
- Common (1% to 10%): Asthenia,
- Frequency not reported: Fever, flu syndrome, tinnitus, vertigo
Fever, flu syndrome, and tinnitus have been reported in less than 3%; vertigo in less than 1%.
Genitourinary
- Frequency not reported: Urinary frequency, cystitis, glycosuria, impotence, urinary incontinence, urinary retention
Urinary frequency has been reported in less than 3% of patients; cystitis, glycosuria, impotence, urinary incontinence, and urinary retention in less than 1%.
Ocular
- Frequency not reported: Altered vision, dry eyes
Altered vision and dry eyes have been reported in less than 1% of patients.
Immunologic
- Common (1% to 10%): Infection
Endocrine
Opioids:
- Postmarketing reports: Adrenal insufficiency, androgen deficiency
Musculoskeletal
- Common (1% to 10%): Pain
- Frequency not reported: Myalgia, arthralgia
Pain has been reported in less than 3% of patients; myalgia and arthralgia in less than 1%.
References
1. (2017) "Product Information. Hydrocodone-Ibuprofen (hydrocodone-ibuprofen)." Par Pharmaceutical Inc (formerly Qualitest Pharmaceuticals Inc)
More about Reprexain (hydrocodone / ibuprofen)
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- Dosage information
- During pregnancy
- Drug class: narcotic analgesic combinations
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Further information
Reprexain side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.