Ibudone Side Effects

Generic name: hydrocodone / ibuprofen

Medically reviewed by Drugs.com. Last updated on May 9, 2024.

Note: This document provides detailed information about Ibudone Side Effects associated with hydrocodone / ibuprofen. Some dosage forms listed on this page may not apply specifically to the brand name Ibudone.

Applies to hydrocodone / ibuprofen: oral tablet.

Common side effects of Ibudone

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 Ibudone

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

Ibudone 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.

Medical Disclaimer