Ibuprofen (oral)

Ibuprofen (oral)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Ibuprofen (oral) is an analgesic, anti-inflammatory agent that is FDA approved for the treatment of minor aches and pains. There is a Black Box Warning for this drug as shown here. Common adverse reactions include hypotension, rash, hypernatremia, hypoalbuminemia, hypoproteinemia, elevated serum LDH level, flatulence, nausea, vomiting, heart burn, thrombocytosis, bacteremia, dizziiness, headache, elevated serum BUN, bacterial pneumonia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Fever

• Dosing Information

• Dosage

Headache

• Dosing Information

• Dosage

Migraine

• Dosing Information

• Dosage

Osteoarthritis

• Dosing Information

• Dosage

Pain

• Dosing Information

• Dosage

Primary dysmenorrhea

• Dosing Information

• Dosage

Rheumatoid arthritis

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Ibuprofen (oral) in adult patients.

Non–Guideline-Supported Use

Condition1

       Cystic fibrosisView additional information.
       Patent ductus arteriosusView additional information.

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibuprofen (oral) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Ibuprofen (oral) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Ibuprofen (oral) in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ibuprofen (oral) in pediatric patients.

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Allergy alert:

Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:

   hives
   facial swelling
   asthma (wheezing)
   shock
   skin reddening
   rash
   blisters

If an allergic reaction occurs, stop use and seek medical help right away.

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

   are age 60 or older
   have had stomach ulcers or bleeding problems
   take a blood thinning (anticoagulant) or steroid drug
   take other drugs containing prescription or non-prescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
   have 3 or more alcoholic drinks every day while using this product
   take more or for a longer time than directed

Do not use

   if you have ever had an allergic reaction to any other pain reliever/fever reducer
   right before or after heart surgery

Ask a doctor before use if

   stomach bleeding warning applies to you
   you have problems or serious side effects from taking pain relievers or fever reducers
   you have a history of stomach problems, such as heartburn
   you have high blood pressure, heart disease, liver cirrhosis, kidney disease, or asthma
   you are taking a diuretic

Ask a doctor or pharmacist before use if you are

   under a doctor's care for any serious condition
   taking aspirin for heart attack or stroke, because ibuprofen may decrease this benefit of aspirin
   taking any other drug

When using this product

   take with food or milk if stomach upset occurs
   the risk of heart attack or stroke may increase if you use more than directed or for longer than directed

Stop use and ask a doctor if

   you experience any of the following signs of stomach bleeding:
       feel faint
       vomit blood
       have bloody or black stools
       have stomach pain that does not get better
   pain gets worse or lasts more than 10 days
   fever gets worse or lasts more than 3 days
   redness or swelling is present in the painful area
   any new symptoms appear

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Ibuprofen (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Ibuprofen (oral) in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ibuprofen (oral) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ibuprofen (oral) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ibuprofen (oral) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Ibuprofen (oral) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Ibuprofen (oral) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Ibuprofen (oral) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ibuprofen (oral) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ibuprofen (oral) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ibuprofen (oral) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ibuprofen (oral) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ibuprofen (oral) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Ibuprofen (oral) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Ibuprofen (oral) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Ibuprofen (oral) in the drug label.

Pharmacology

There is limited information regarding Ibuprofen (oral) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Ibuprofen (oral)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ibuprofen (oral) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Ibuprofen (oral) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Ibuprofen (oral) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Ibuprofen (oral) in the drug label.

How Supplied

Storage

There is limited information regarding Ibuprofen (oral) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Ibuprofen (oral) in the drug label.

Precautions with Alcohol

• Alcohol-Ibuprofen (oral) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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