Motrin

Name: Motrin

Motrin Drug Class

Motrin is part of the drug class:

  • Antiinflammatory preparations, non steroids for topical use

Side Effects of Motrin

Serious side effects have been reported with ibuprofen. See “Drug Precautions” section.

Common side effects of ibuprofen include:

  • stomach effects:  nausea, heartburn, diarrhea, stomach irritation, bloating or flatulence, constipation
  • others: headache, dizziness, ringing in the ears, swelling of arms or legs, rash

This is not a complete list of ibuprofen side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Motrin Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of ibuprofen, there are no specific foods that you must exclude from your diet when receiving ibuprofen.

 

Inform MD

Before taking ibuprofen, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • have kidney problems
  • have liver problems
  • have heart problems
  • have had a stomach bleed or ulcer (hole in the lining of the stomach) in the past
  • have asthma
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Before Using Motrin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of ibuprofen in children below 6 months of age. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of ibuprofen in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require adjustment of dosage in patients receiving ibuprofen .

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Ketorolac

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abciximab
  • Aceclofenac
  • Acemetacin
  • Acenocoumarol
  • Amiloride
  • Amineptine
  • Amitriptyline
  • Amitriptylinoxide
  • Amoxapine
  • Amtolmetin Guacil
  • Anagrelide
  • Apixaban
  • Ardeparin
  • Argatroban
  • Aspirin
  • Balsalazide
  • Bemiparin
  • Bendroflumethiazide
  • Benzthiazide
  • Betamethasone
  • Betrixaban
  • Bismuth Subsalicylate
  • Bivalirudin
  • Bromfenac
  • Budesonide
  • Bufexamac
  • Bumetanide
  • Cangrelor
  • Celecoxib
  • Certoparin
  • Chlorothiazide
  • Chlorthalidone
  • Choline Magnesium Trisalicylate
  • Choline Salicylate
  • Cilostazol
  • Citalopram
  • Clomipramine
  • Clonixin
  • Clopamide
  • Clopidogrel
  • Cortisone
  • Cyclopenthiazide
  • Cyclosporine
  • Dabigatran Etexilate
  • Dalteparin
  • Danaparoid
  • Deflazacort
  • Desipramine
  • Desirudin
  • Desmopressin
  • Desvenlafaxine
  • Dexamethasone
  • Dexibuprofen
  • Dexketoprofen
  • Diazoxide
  • Dibenzepin
  • Diclofenac
  • Diflunisal
  • Digoxin
  • Dipyridamole
  • Dipyrone
  • Dothiepin
  • Doxepin
  • Droxicam
  • Duloxetine
  • Edoxaban
  • Enoxaparin
  • Eplerenone
  • Epoprostenol
  • Eptifibatide
  • Escitalopram
  • Ethacrynic Acid
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Feverfew
  • Floctafenine
  • Flufenamic Acid
  • Fluocortolone
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Fondaparinux
  • Furosemide
  • Ginkgo
  • Gossypol
  • Heparin
  • Hydrochlorothiazide
  • Hydrocortisone
  • Hydroflumethiazide
  • Ibuprofen
  • Iloprost
  • Imipramine
  • Indapamide
  • Indomethacin
  • Ketoprofen
  • Lepirudin
  • Levomilnacipran
  • Lithium
  • Lofepramine
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Magnesium Salicylate
  • Meadowsweet
  • Meclofenamate
  • Mefenamic Acid
  • Melitracen
  • Meloxicam
  • Mesalamine
  • Methotrexate
  • Methyclothiazide
  • Methylprednisolone
  • Metolazone
  • Milnacipran
  • Morniflumate
  • Nabumetone
  • Nadroparin
  • Naproxen
  • Nefazodone
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Nortriptyline
  • Olsalazine
  • Opipramol
  • Oxaprozin
  • Oxyphenbutazone
  • Paramethasone
  • Parecoxib
  • Parnaparin
  • Paroxetine
  • Pemetrexed
  • Pentosan Polysulfate Sodium
  • Pentoxifylline
  • Phenindione
  • Phenprocoumon
  • Phenylbutazone
  • Phenyl Salicylate
  • Piketoprofen
  • Piroxicam
  • Polythiazide
  • Pralatrexate
  • Prasugrel
  • Prednisolone
  • Prednisone
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Protein C
  • Protriptyline
  • Reboxetine
  • Reviparin
  • Rivaroxaban
  • Rofecoxib
  • Salicylamide
  • Salicylic Acid
  • Salsalate
  • Sertraline
  • Sibutramine
  • Sodium Salicylate
  • Spironolactone
  • Sulfasalazine
  • Sulindac
  • Tacrolimus
  • Tenoxicam
  • Tianeptine
  • Tiaprofenic Acid
  • Ticagrelor
  • Ticlopidine
  • Tinzaparin
  • Tirofiban
  • Tolfenamic Acid
  • Tolmetin
  • Torsemide
  • Treprostinil
  • Triamterene
  • Trichlormethiazide
  • Trimipramine
  • Trolamine Salicylate
  • Valdecoxib
  • Venlafaxine
  • Vilazodone
  • Vorapaxar
  • Vortioxetine
  • Warfarin
  • Xipamide

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acebutolol
  • Alacepril
  • Amikacin
  • Atenolol
  • Azilsartan
  • Azilsartan Medoxomil
  • Benazepril
  • Betaxolol
  • Bisoprolol
  • Candesartan
  • Captopril
  • Carteolol
  • Carvedilol
  • Celiprolol
  • Cilazapril
  • Delapril
  • Enalapril
  • Enalaprilat
  • Eprosartan
  • Esmolol
  • Fosinopril
  • Imidapril
  • Irbesartan
  • Labetalol
  • Levobunolol
  • Lisinopril
  • Losartan
  • Metipranolol
  • Metoprolol
  • Moexipril
  • Nadolol
  • Nebivolol
  • Olmesartan
  • Oxprenolol
  • Penbutolol
  • Pentopril
  • Perindopril
  • Pindolol
  • Practolol
  • Propranolol
  • Quinapril
  • Ramipril
  • Sotalol
  • Spirapril
  • Telmisartan
  • Temocapril
  • Timolol
  • Trandolapril
  • Valsartan
  • Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Anemia or
  • Asthma or
  • Bleeding problems or
  • Blood clots or
  • Edema (fluid retention or body swelling) or
  • Heart attack, history of or
  • Heart disease (e.g., congestive heart failure) or
  • High blood pressure or
  • Kidney disease or
  • Liver disease (e.g., hepatitis) or
  • Stomach or intestinal ulcers or bleeding or
  • Stroke, history of—Use with caution. This medicine may make these conditions worse .
  • Aspirin sensitivity, history of—This medicine should NOT be used in patients with this condition .
  • Diabetes—Use with caution. The suspension form of this medicine contains sugar .
  • Heart surgery (e.g., coronary artery bypass graft [CABG] surgery)—This medicine should NOT be used to relieve pain right before or after the surgery .

Uses of Motrin

  • It is used to ease pain, swelling, and fever.
  • It is used to ease painful period (menstrual) cycles.
  • It is used to treat arthritis.
  • It may be given to you for other reasons. Talk with the doctor.

Overdosage

The toxicity of ibuprofen overdose is dependent upon the amount of drug ingested and the time elapsed since ingestion, though individual response may vary, which makes it necessary to evaluate each case individually. Although uncommon, serious toxicity and death have been reported in the medical literature with ibuprofen overdosage. The most frequently reported symptoms of ibuprofen overdose include abdominal pain, nausea, vomiting, lethargy and drowsiness. Other central nervous system symptoms include headache, tinnitus, CNS depression and seizures. Metabolic acidosis, coma, acute renal failure and apnea (primarily in very young children) may rarely occur. Cardiovascular toxicity, including hypotension, bradycardia, tachycardia and atrial fibrillation, also have been reported.

The treatment of acute ibuprofen overdose is primarily supportive. Management of hypotension, acidosis and gastrointestinal bleeding may be necessary. In cases of acute overdose, the stomach should be emptied through ipecac-induced emesis or lavage. Emesis is most effective if initiated within 30 minutes of ingestion. Orally administered activated charcoal may help in reducing the absorption and reabsorption of ibuprofen.

In children, the estimated amount of ibuprofen ingested per body weight may be helpful to predict the potential for development of toxicity although each case must be evaluated. Ingestion of less than 100 mg/kg is unlikely to produce toxicity. Children ingesting 100 to 200 mg/kg may be managed with induced emesis and a minimal observation time of four hours. Children ingesting 200 to 400 mg/kg of ibuprofen should have immediate gastric emptying and at least four hours observation in a health care facility. Children ingesting greater than 400 mg/kg require immediate medical referral, careful observation and appropriate supportive therapy. Ipecac-induced emesis is not recommended in overdoses greater than 400 mg/kg because of the risk for convulsions and the potential for aspiration of gastric contents.

In adult patients the history of the dose reportedly ingested does not appear to be predictive of toxicity. The need for referral and follow-up must be judged by the circumstances at the time of the overdose ingestion. Symptomatic adults should be carefully evaluated, observed and supported.

How is Motrin Supplied

Motrin® (ibuprofen) Suspension, 100 mg/5 mL

Orange-colored, berry- flavored suspension

- Bottles of 120 mL – NDC 0045-0448-04
- Bottles of 480 mL – NDC 0045-0448-16

Shake well before using. Store at controlled room temperature [15º to 30ºC (59º to 86ºF)]

Caution: Federal Law prohibits dispensing without prescription.

McNEIL CONSUMER HEALTHCARE
DIVISION OF McNEIL-PPC, INC.
FORT WASHINGTON, PA 19034-USA

April 2009

Important information

Motrin can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Motrin may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using ibuprofen, especially in older adults.

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 Motrin 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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