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Hydrocodone / ibuprofen Side Effects

In Summary

Commonly reported side effects of hydrocodone/ibuprofen include: drowsiness and dyspepsia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to hydrocodone / ibuprofen: oral tablet

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:

Less Common or Rare

  • Bloody stools
  • burning feeling in the chest or stomach
  • congestion in the chest
  • 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
  • ringing or buzzing in the ears
  • tightness in the chest
  • troubled breathing
  • skin rash, hives, or itching
  • stomach pain
  • tenderness in the stomach

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 or vomiting
  • severe drowsiness
  • severe stomach pain
  • skin rash
  • slow heartbeat
  • slow or troubled breathing
  • stiff neck or back
  • swelling of the face, fingers, feet, or lower legs

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

  • Anxiety
  • constipation
  • dry mouth
  • gas
  • increased sweating
  • nervousness
  • pounding heartbeat
  • sleepiness
  • trouble in sleeping
  • unusual tiredness or weakness

Less Common or Rare

  • Decreased appetite
  • decrease in sexual ability
  • depression
  • 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
  • trembling or shaking of the hands or feet
  • unexplained weight loss
  • unusual feeling of well-being
  • visual disturbances

For Healthcare Professionals

Applies to hydrocodone / ibuprofen: oral tablet

General

The more commonly reported adverse reactions have included headache, dizziness, constipation, and dyspepsia.[Ref]

Respiratory

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%.

Frequency not reported: Dyspnea, hiccups, pharyngitis, rhinitis, asthma, bronchitis, hoarseness, increased cough, pulmonary congestion, pneumonia, shallow breathing, sinusitis

Gastrointestinal

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.

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

Cardiovascular

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.

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

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

Urinary frequency has been reported in less than 3% of patients; cystitis, glycosuria, impotence, urinary incontinence, and urinary retention in less than 1%.

Frequency not reported: Urinary frequency, cystitis, glycosuria, impotence, urinary incontinence, urinary retention

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

Pain has been reported in less than 3% of patients; myalgia and arthralgia in less than 1%.

Common (1% to 10%): Pain

Frequency not reported: Myalgia, arthralgia

References

1. "Product Information. Hydrocodone-Ibuprofen (hydrocodone-ibuprofen)." Par Pharmaceutical Inc (formerly Qualitest Pharmaceuticals Inc), Huntsville, AL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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