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.

Precautions

It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Signs of an overdose include: cold, clammy skin, coughing that sometimes produces a pink frothy sputum, dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

Avoid using this medicine and an MAO inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within 14 days of each other.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve dizziness or lightheadedness.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Some signs of serious heart problems are chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Check with your doctor right away if you notice any of these warning signs.

This medicine may cause bleeding in your stomach or bowels. This problem can happen without warning signs. This is more likely to occur if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroids or a blood thinner). Call your doctor right away if you have severe stomach pain, black, tarry stools, or are vomiting blood or material that looks like coffee grounds.

Liver problems may occur while you are using this medicine. Check with your doctor right away if you have stomach pain or tenderness, clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

This medicine may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

This medicine may cause serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Using an NSAID medicine during late pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

Hydrocodone and ibuprofen combination will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds, sedatives, tranquilizers, sleeping medicine, or other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or lightheaded, or to feel a false sense of well-being. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. If these reactions are especially bothersome, check with your doctor.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Hydrocodone and ibuprofen combination may cause dry mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if you take this medicine for a long time and dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

If you have heart disease or congestive heart failure (CHF), tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Check with your doctor immediately if blurred vision, difficulty with reading, or any other change in vision occurs during or after your treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

This medicine may cause constipation. This is more common if you use it for a long time. Ask your doctor if you should also use a laxative to prevent and treat constipation.

This medicine may cause hyperkalemia (high potassium in the blood). Check with your doctor right away if you have confusion, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, stomach pain, difficult breathing, or weakness or heaviness of the legs.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

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%.

See also:

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.

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