Advil Film-Coated Side Effects

Generic name: ibuprofen

Medically reviewed by Drugs.com. Last updated on Jan 16, 2025.

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

Applies to ibuprofen: intravenous solution.

Other dosage forms:

• oral capsule liquid filled, oral suspension, oral tablet, oral tablet chewable

Precautions

It is very important that your doctor check your progress while you or your child receives this medicine. This will allow your doctor to see if the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

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 or in people who use this medicine for a longer time. Tell your doctor if you or your child has chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, slurred speech, unusual sweating, or faintness.

This medicine may increase risk of bleeding problems. including bleeding in your stomach or intestines. 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).

Liver problems may occur while you are using this medicine. Check with your doctor right away if you or your child has 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.

If you or your child are rapidly gaining weight, having chest pain or discomfort, extreme tiredness or weakness, irregular breathing, irregular heartbeat, trouble breathing, or excessive swelling of the hands, wrist, ankles, or feet, check with your doctor immediately. These may be symptoms of heart problems or your body keeping too much water.

This medicine may cause kidney problems. Tell your doctor right away if you or your child has blood in the urine, decreased urine output, confusion, dizziness, headache, muscle twitching, rapid weight gain, swelling of your face, ankles, or hands, or unusual tiredness or weakness.

Hyperkalemia (high potassium in the blood) may occur while you are receiving this medicine. Call your doctor right away if you or your child has confusion, weakness, uneven heartbeat, trouble breathing, numbness or tingling in your hands, feet, or lips.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after you get the injection.

Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. 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, 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 this medicine during the later part of your pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

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

Check with your doctor right away if you or your child starts to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

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.

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.

Serious side effects of Advil Film-Coated

Along with its needed effects, ibuprofen (the active ingredient contained in Advil Film-Coated) 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 or nurse immediately if any of the following side effects occur while taking ibuprofen:

Other side effects of Advil Film-Coated

Some side effects of 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:

For healthcare professionals

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

General adverse events

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

• 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]

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]

Hematologic

• 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]

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]

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

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

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]

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]

See also:

Frequently asked questions

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Further information

Advil Film-Coated 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