Advil

Name: Advil

Manufacturer

  • Cheshire Pharm. Systems

  • Lil' Drug Store Products, Inc.

  • Pfizer Consumer Healthcare

  • Quality Care Pharmaceuticals

  • Wyeth Consumer Healthcare

  • Wyeth Pharmaceuticals, Inc.

Advil and Lactation

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if ibuprofen is excreted in human breast milk or if it will harm your nursing baby.

What happens if I miss a dose?

Since ibuprofen is used when needed, you may not be on a dosing schedule. If you are on a schedule, use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Ibuprofen side effects

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using ibuprofen and call your doctor at once if you have:

  • changes in your vision;

  • shortness of breath (even with mild exertion);

  • swelling or rapid weight gain;

  • the first sign of any skin rash, no matter how mild;

  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

  • liver problems--nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • kidney problems--little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;

  • low red blood cells (anemia)--pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

  • severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • upset stomach, mild heartburn, nausea, vomiting;

  • bloating, gas, diarrhea, constipation;

  • dizziness, headache, nervousness;

  • mild itching or rash; or

  • ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect ibuprofen?

Ask your doctor before using ibuprofen if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use ibuprofen if you are also using any of the following drugs:

  • lithium;

  • methotrexate;

  • a blood thinner (warfarin, Coumadin, Jantoven);

  • heart or blood pressure medication, including a diuretic or "water pill"; or

  • steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with ibuprofen, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Uses For Advil

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate pain, and helps to relieve symptoms of arthritis (osteoarthritis, rheumatoid arthritis, or juvenile arthritis), such as inflammation, swelling, stiffness, and joint pain. This medicine does not cure arthritis and will help you only as long as you continue to take it .

In addition, ibuprofen can be used to treat fever, menstrual cramps, and other conditions as determined by your doctor .

This medicine is available both over-the-counter (OTC) and with your doctor's prescription .

Directions

Advil Tablets

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years of age and over: take 1 tablet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 tablet, 2 tablets may be used
  • do not exceed 6 tablets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Advil Caplets

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years of age and over: take 1 caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 caplet, 2 caplets may be used
  • do not exceed 6 caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Advil Gel Caplets

  • do not take more than directed
  • the smallest effective dose should be used
  • adults and children 12 years of age and over: take 1 gel caplet every 4 to 6 hours while symptoms persist
  • if pain or fever does not respond to 1 gel caplet, 2 gel caplets may be used
  • do not exceed 6 gel caplets in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • read all warnings and directions before use. Keep carton.
  • store at 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

For Healthcare Professionals

Applies to ibuprofen: compounding powder, intravenous solution, oral capsule, oral suspension, oral tablet, oral tablet chewable

General

The most frequently reported adverse effects were gastrointestinal (GI) in nature and included nausea, vomiting, flatulence, and diarrhea.

Patent Ductus Arteriosus: The most frequently reported adverse effects were sepsis, anemia, intraventricular bleeding, apnea, GI disorders, impaired renal function, respiratory infection, skin lesions, hypoglycemia, hypocalcemia, and respiratory failure.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 57%), vomiting (up to 22%), flatulence (up to 16%), diarrhea (up to 10%)
Common (1% to 10%): Dyspepsia, abdominal discomfort, epigastric pain, heartburn, abdominal distress, indigestion, constipation, abdominal cramps/pain, fullness of GI tract, bloating, GI hemorrhage, melena
Uncommon (0.1% to 1%): Abdominal distention, dyspepsia, gastritis
Very rare (less than 0.01%): Peptic ulcer, perforation, hematemesis, mouth ulceration, exacerbation of colitis, exacerbation of Crohn's disease
Frequency not reported: Dry mouth, duodenitis, esophagitis, gastric ulcer, duodenal ulcer, GI bleeding, glossitis, rectal bleeding, stomatitis, eructation, gingival ulcer, pancreatitis

Patent Ductus Arteriosus:
Very common (10% or more): GI disorders non-necrotizing enterocolitis (22%)
Common (1% to 10%): Necrotizing enterocolitis, intestinal perforation
Frequency not reported: Abdominal distension, gastroesophageal reflux, gastritis, ileus, inguinal hernia
Postmarketing reports: GI perforation[Ref]

Cardiovascular

Very common (10% or more): Hemorrhage (up to 10%), hypertension (10%), hypotension (10%)
Very rare (less than 0.01%): Cardiac failure
Frequency not reported: Congestive heart failure, tachycardia, arrhythmia, myocardial infarction, palpitations, vasculitis, sinus bradycardia, angina pectoris, thrombotic events

Patent Ductus Arteriosus:
Frequency not reported: Tachycardia, cardiac failure, hypotension[Ref]

Nervous system

Very common (10% or more): Headache (up to 12%)
Common (1% to 10%): Dizziness, nervousness
Very rare (less than 0.01%): Cerebrovascular accident
Frequency not reported: Syncope, drowsiness, paresthesia, somnolence, tremors, convulsions, coma

Patent Ductus Arteriosus:
Common (1% to 10%): Intraventricular hemorrhage, periventricular hemorrhage
Frequency not reported: Convulsions[Ref]

Renal

The number of total renal events in preterm infants within 30 days of therapy following IV use was 21% and included increased blood urea (7%), renal insufficiency/impairment (6%), reduced urine output (3%), increased blood creatinine (3%), renal failure (1%), and increased blood urea with hematuria (1%).[Ref]

Very rare (less than 0.01%): Acute renal failure, renal papillary necrosis, interstitial nephritis, nephrotic syndrome, renal failure, renal insufficiency
Frequency not reported: Cystitis, azotemia, creatinine clearance decreased, glomerulitis, tubular necrosis, nephrotoxicity

Patent Ductus Arteriosus:
Very common (10% or more): Renal events (21%)
Uncommon (0.1% to 1%): Acute renal failure[Ref]

Hematologic

The incidence of total bleeding events within 30 days of therapy with IV use in preterm infants was 32%. This percentage included grade 1 and 2 intraventricular hemorrhage (15%), grade 3 and 4 intraventricular hemorrhage (15%), and other bleeding (6%).[Ref]

Very common (10% or more): Anemia (up to 36%), eosinophilia (up to 26%), neutropenia (up to 13%), thrombocythemia (up to 10%)
Common (1% to 10%): Hemoglobin decreased
Very rare (less than 0.01%): Leukopenia, thrombocytopenia, agranulocytosis, hemolytic anemia, aplastic anemia, pancytopenia, hematocrit decreased
Frequency not reported: lymphadenopathy, bleeding episodes

Patent Ductus Arteriosus:
Very common (10% or more): Anemia (32%), total bleeding (32%), intraventricular hemorrhage (29%), Neutropenia, thrombocytopenia[Ref]

Dermatologic

Common (1% to 10%): Rash, maculopapular rash, pruritus
Very rare (less than 0.01%): Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis
Frequency not reported: Ecchymosis, purpura, alopecia, sweating, photosensitivity, angioedema, exfoliative dermatitis, urticaria, vesiculobullous eruptions, Henoch Schonlein vasculitis

Patent Ductus Arteriosus:
Very common (10% or more): Skin lesion/irritation (16%)[Ref]

Metabolic

Very common (10% or more): Hypokalemia (up to 19%), hypoproteinemia (up to 13%), blood urea increased (10%), hypernatremia (10%), hypoalbuminemia (10%)
Common (1% to 10%): Appetite decreased, fluid retention
Frequency not reported: Appetite changes, hyperglycemia, hypoglycemic reaction, acidosis

Patent Ductus Arteriosus:
Very common (10% or more): Hypoglycemia (12%), hypocalcemia (12%), blood creatinine increased, blood sodium decreased
Common (1% to 10%): Hypernatremia
Frequency not reported: Feeding problems, hyperglycemia[Ref]

Other

Very common (10% or more): Bacteremia (13%), blood LDH increased (up to 10%)
Common (1% to 10%): Peripheral edema, wound hemorrhage, tinnitus, hearing impairment, edema, fatigue
Very rare (less than 0.01%): Aseptic meningitis, vertigo, exacerbation of infection-related inflammations
Frequency not reported: Fever, infection, sepsis, weight changes, asthenia, malaise, pseudo-tumor, hearing loss, drowsiness

Patent Ductus Arteriosus:
Very common (10% or more): Sepsis (43%)
Common (1% to 10%): Edema, fluid retention
Frequency not reported: Various infections[Ref]

Respiratory

Very common (10% or more): Bacterial pneumonia (up to 10%)
Common (1% to 10%): Cough
Very rare (less than 0.01%): Asthma, bronchospasm, dyspnea, wheezing
Frequency not reported: Apnea, respiratory depression, pneumonia, rhinitis, epistaxis

Patent Ductus Arteriosus:
Very common (10% or more): Apnea (28%), respiratory infection (19%), respiratory failure (10%), bronchopulmonary dysplasia
Common (1% to 10%): Atelectasis, pulmonary hemorrhage
Uncommon (0.1% to 1%): Hypoxemia
Postmarketing reports: Pulmonary hypertension[Ref]

Hepatic

Very rare (less than 0.01%): Hepatitis, jaundice
Frequency not reported: Hepatorenal syndrome, liver necrosis, liver failure, abnormal liver function tests

Patent Ductus Arteriosus:
Frequency not reported: Cholestasis, jaundice[Ref]

Hypersensitivity

Hypersensitivity reactions have been reported and may consist of any of the following: a syndrome of abdominal pain, fever, chills, nausea, vomiting, and anaphylaxis; respiratory tract reactivity comprising bronchospasm, asthma/aggravated asthma, or dyspnea; skin reactions, which rarely included exfoliative and bullous dermatoses, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, pruritus, and urticaria.[Ref]

Frequency not reported: Anaphylactoid reactions, hypersensitivity reaction[Ref]

Ocular

Very rare (less than 0.01%): Visual disturbances
Frequency not reported: Blurred vision, amblyopia, diminished vision, scotomata, changes in color vision, conjunctivitis, dry eyes, diplopia, optic neuritis, cataracts, optic neuritis, toxic optic neuropathy[Ref]

Musculoskeletal

Frequency not reported: Lupus erythematosus syndrome[Ref]

Psychiatric

Frequency not reported: Anxiety, confusion, depression, dream abnormalities, insomnia, emotional lability, hallucinations[Ref]

Genitourinary

Common (1% to 10%): Urinary retention
Very rare (less than 0.01%): Proteinuria, hematuria
Frequency not reported: Dysuria, oliguria, polyuria, menorrhagia

Patent Ductus Arteriosus:
Very common (10% or more): Oliguria, hematuria
Common (1% to 10%): Urinary tract infection[Ref]

Immunologic

Frequency not reported: Serum sickness[Ref]

Local

Common (1% to 10%): Infusion site pain
Postmarketing reports: Transient sensation of burning in mouth/throat

Patent Ductus Arteriosus:
Frequency not reported: Injection site reactions[Ref]

Endocrine

Frequency not reported: Gynecomastia

Patent Ductus Arteriosus:
Common (1% to 10%): Adrenal insufficiency[Ref]

Some side effects of Advil may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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