Motrin (Ibuprofen) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

The most frequent type of adverse reaction occurring with ibuprofen is gastrointestinal. In controlled clinical trials, the percentage of adult patients reporting one or more gastrointestinal complaints ranged from 4% to 16%.

In controlled studies in adults, when ibuprofen was compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin- or indomethacin-treated patients.

Adverse reactions observed during controlled clinical trials in adults at an incidence greater than 1% are listed in the chart. Those reactions listed under the heading "Incidence Greater than 1% (but less than 3%) Probable Causal Relationship," encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks.

Still other reactions, occurring less frequently than 1 in 100, were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: "Incidence less than 1%--Probable Causal Relationships," lists reactions with Ibuprofen therapy for which the probability of a causal relationship exists; this category was completed over time with postmarketing serious adverse reactions. "Incidence less than 1% --Causal Relationship Unknown," lists reactions with ibuprofen therapy for which a causal relationship has not been established, but are presented as alerting information for physicians.

INCIDENCE OF 1% OR GREATER

Probable Causal Relationship

Incidence between 3 and 9%=ADR marked with*

Incidence between 1 and <3%=unmarked ADR

Cardiovascular system:   Edema, fluid retention (generally responds promptly to drug discontinuation) (See PRECAUTIONS).

Digestive system:   Nausea*, epigastric pain*, heartburn*, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of Gl tract (bloating and flatulence).

Nervous system:   Dizziness*, headache, nervousness.

Skin and appendages:   Rash* (including maculopapular type), pruritus

Specal senses:   Tinnitus.

INCIDENCE LESS THAN 1%

Probable Causal Relationship:   The following adverse reactions were reported in clincial trials at an incidence of less than 1%, or were reported from postmarketing or foreign experience. The probability exists between the drug and these adverse reactions.

Body as a whole:   Anaphylaxis and anaphylactoid reactions (see WARNINGS).

Cardiovascular system:   Cerebrovascular accident, hypotension, congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations.

Digestive system:   Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage, pancreatitis, melena, gastritis, duodenitis, esophagitis, hematemesis, hepatorenal syndrome, liver necrosis, liver failure, hepatitis, jaundice, abnormal liver tests.

Hematologic system:   Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decrease in hemoglobin and hematocrit (see PRECAUTIONS), pancytopenia.

Nervous system:   Depression, insomnia, confusion, emotional lability, somnolence, convulsions, aseptic meningitis with fever and coma (see PRECAUTIONS).

Respiratory:   Bronchospasm, dyspnea, apnea.

Skin and appendages:   Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia, exfoliative dermatitis, Lyell's syndrome (toxic epidermal necrolysis), photosensitivity reactions.

Special senses:   Hearing loss, amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision) (see PRECAUTIONS --Other Precautions).

Urogenital system:   Acute renal failure in patients with pre-existing significantly impaired renal function (see PRECAUTIONS), renal papillary necrosis, tubular necrosis, glomerulitis, decreased creatinine clearance, polyuria, azotemia, cystitis, hematuria.

Miscellaneous:   Dry eyes and mouth, gingival ulcer, rhinitis.

INCIDENCE LESS THAN 1%

Causal Relationship Unknown:   The following adverse reactions occurred at an incidence of less than 1% in clinical trials, or were suggested by marketing experience under circumstances where a causal relationship could not be definitely established. They are listed as alerting information for the physician.

Allergic:   Serum sickness, lupus erythematosus syndrome, Henoch-Sch[omacr ]nlein vasculitis, angioedema.

Cardivascular system:   Arrhythmias (sinus tachycardia, sinus bradycardia).

Hematologic system:   Bleeding episodes (e.g., epistaxis, menorrhagia).

Metabolic/endocrine:   Gynecomastia, hypoglycemic reaction, acidosis.

Nervous system:   Paresthesias, hallucinations, dream abnormalities, pseudo-tumor cerebri.

Special senses:   Conjunctivitis, diplopia, optic neuritis, cataracts.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO MOTRIN

Possible Motrin side effects / adverse reactions in 73 year old female

Reported by a physician from United States on 2007-01-19

Patient: 73 year old female

Reactions: Gastrointestinal Haemorrhage, Pain, Dyspnoea Exertional, Haematocrit Decreased, Fatigue, Iron Deficiency Anaemia, Pulmonary Oedema, Muscle Spasms, Hiatus Hernia, Stomach Discomfort, Occult Blood Positive, Haemoglobin Decreased, Syncope, Diverticulum, Ventricular Tachycardia, Suicide Attempt, Asthenia, Depressed Mood

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Aleve
    Dosage: total daily dose: 880 mg unit dose: 220 mg
    Administration route: Oral
    Indication: Arthralgia

Motrin
    Dosage: total daily dose: 2400 mg unit dose: 800 mg
    Indication: Osteoarthritis

Naprosyn
    Indication: Osteoarthritis

Possible Motrin side effects / adverse reactions in 49 year old male

Reported by a pharmacist from United States on 2007-01-22

Patient: 49 year old male weighing 105.0 kg (231.0 pounds)

Reactions: Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Salsalate 750mg
    Dosage: 750mg q8 h prn po
    Administration route: Oral
    Indication: Back Pain
    Start date: 2006-08-21

Motrin
    Dosage: 800mg prn po
    Administration route: Oral
    Indication: Pain

ASA 81 MG Daily PO
    Dosage: 81mg daily po
    Administration route: Oral
    Start date: 2006-06-04

Possible Motrin side effects / adverse reactions in 40 year old female

Reported by a pharmacist from United States on 2007-02-01

Patient: 40 year old female weighing 65.0 kg (143.0 pounds)

Reactions: Vomiting, Medication Error, Nausea, Incorrect Dose Administered, Abdominal Pain Upper, Haematemesis

Adverse event resulted in: life threatening event

Suspect drug(s):
Motrin
    Indication: Toothache
    Start date: 2007-01-12
    End date: 2007-01-26

Tylenol
    Indication: Toothache
    Start date: 2007-01-12
    End date: 2007-01-26

Possible Motrin side effects / adverse reactions in 21 year old female

Reported by a physician from United States on 2007-02-05

Patient: 21 year old female

Reactions: Abdominal Pain, Jaundice, Weight Decreased, Malaise, Fatigue, Pruritus, Self-Medication, Liver Disorder

Suspect drug(s):
Bextra
    Start date: 2004-12-01
    End date: 2004-12-01

Motrin
    Start date: 2004-12-01
    End date: 2004-12-01

Other drugs received by patient: Birth Control Pill; Multi-Vitamin; Atarax; Bactrim

Possible Motrin side effects / adverse reactions in 36 year old female

Reported by a individual with unspecified qualification from United States on 2007-02-09

Patient: 36 year old female

Reactions: Suicide Attempt

Suspect drug(s):
Lunesta
    Dosage: oral
    Administration route: Oral

Tranxene

Motrin

Possible Motrin side effects / adverse reactions in 28 year old male

Reported by a consumer/non-health professional from United States on 2007-02-22

Patient: 28 year old male weighing 79.0 kg (173.8 pounds)

Reactions: Renal Disorder, Blood Pressure Inadequately Controlled, Appendicectomy, Hypertension, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Adalat
    Dosage: total daily dose: 90 mg
    Administration route: Oral
    Indication: Hypertension

Motrin
    Dosage: total daily dose: 1800 mg
    Administration route: Oral
    Indication: Swelling
    Start date: 1995-03-29
    End date: 1995-04-16

Motrin
    Dosage: total daily dose: 1800 mg
    Administration route: Oral
    Start date: 1995-04-24
    End date: 1995-05-23

Possible Motrin side effects / adverse reactions in 49 year old male

Reported by a physician from United States on 2007-02-28

Patient: 49 year old male

Reactions: Optic Atrophy, Optic Neuropathy

Suspect drug(s):
Motrin

Possible Motrin side effects / adverse reactions in 36 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-03-02

Patient: 36 year old female

Reactions: Suicide Attempt, Multiple Drug Overdose

Suspect drug(s):
Tranxene
    Dosage: po
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication
    Start date: 2004-12-01

Tranxene
    Dosage: po
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication
    Start date: 2005-06-01

Lunesta
    Dosage: po
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Motrin
    Indication: Drug USE FOR Unknown Indication

Possible Motrin side effects / adverse reactions in 10 year old female

Reported by a individual with unspecified qualification from United States on 2007-03-07

Patient: 10 year old female weighing 45.4 kg (99.8 pounds)

Reactions: LIP Swelling, Swelling Face

Suspect drug(s):
Motrin
    Dosage: as recommended by weight
    Indication: Pyrexia

Ibuprofen
    Indication: Pain

Possible Motrin side effects / adverse reactions in 28 year old male

Reported by a consumer/non-health professional from United States on 2007-03-30

Patient: 28 year old male weighing 79.0 kg (173.8 pounds)

Reactions: Renal Disorder, Blood Pressure Inadequately Controlled, Appendicectomy, Hypertension, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Adalat
    Dosage: total daily dose: 90 mg
    Administration route: Oral
    Indication: Hypertension

Motrin
    Dosage: total daily dose: 1800 mg
    Administration route: Oral
    Indication: Swelling
    Start date: 1995-03-29
    End date: 1995-04-16

Motrin
    Dosage: total daily dose: 1800 mg
    Administration route: Oral
    Start date: 1995-04-24
    End date: 1995-05-23

Possible Motrin side effects / adverse reactions in 4 year old male

Reported by a individual with unspecified qualification from United States on 2007-04-13

Patient: 4 year old male weighing 18.1 kg (39.9 pounds)

Reactions: Gait Disturbance

Suspect drug(s):
Motrin

Possible Motrin side effects / adverse reactions in 60 year old female

Reported by a physician from United States on 2007-04-16

Patient: 60 year old female weighing 72.0 kg (158.4 pounds)

Reactions: Haematemesis

Adverse event resulted in: hospitalization

Suspect drug(s):
Clonazepam
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-11-22

PEG-Interferon Alfa 2A (RO 25-8310)
    Start date: 2006-01-19
    End date: 2006-12-19

Ribavirin
    Administration route: Oral
    Start date: 2006-01-19
    End date: 2006-12-19

Lisinopril
    Indication: Drug USE FOR Unknown Indication
    Start date: 2005-10-27

Zinc
    Indication: Drug USE FOR Unknown Indication
    Start date: 2007-02-01

Hydrochlorothiazide
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-11-11

Motrin
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-19

Propranolol
    Indication: Drug USE FOR Unknown Indication

Calcium
    Indication: Drug USE FOR Unknown Indication

Other drugs received by patient: Sertraline

Possible Motrin side effects / adverse reactions in 60 year old female

Reported by a physician from United States on 2007-04-24

Patient: 60 year old female weighing 72.0 kg (158.4 pounds)

Reactions: Haematemesis

Adverse event resulted in: hospitalization

Suspect drug(s):
Clonazepam
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-11-22

PEG-Interferon Alfa 2A (RO 25-8310)
    Start date: 2006-01-19
    End date: 2006-12-14

Ribavirin
    Administration route: Oral
    Start date: 2006-01-19
    End date: 2006-12-19

Lisinopril
    Indication: Drug USE FOR Unknown Indication
    Start date: 2005-10-27

Zinc
    Indication: Drug USE FOR Unknown Indication
    Start date: 2007-02-01

Hydrochlorothiazide
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-11-11

Motrin
    Indication: Drug USE FOR Unknown Indication
    Start date: 2006-01-19

Propranolol
    Indication: Drug USE FOR Unknown Indication

Calcium
    Indication: Drug USE FOR Unknown Indication

Other drugs received by patient: Sertraline

Possible Motrin side effects / adverse reactions in 28 year old male

Reported by a consumer/non-health professional from United States on 2007-05-07

Patient: 28 year old male weighing 79.0 kg (173.8 pounds)

Reactions: Renal Disorder, Drug Ineffective, Dialysis, Blood Pressure Inadequately Controlled, Appendicectomy, Pharmaceutical Product Complaint, Hypertension, Renal Failure Acute

Adverse event resulted in: hospitalization

Suspect drug(s):
Adalat
    Dosage: total daily dose: 90 mg
    Administration route: Oral
    Indication: Hypertension

Motrin
    Dosage: total daily dose: 1800 mg
    Administration route: Oral
    Indication: Swelling
    Start date: 1995-03-29
    End date: 1995-04-16

Motrin
    Dosage: total daily dose: 1800 mg
    Administration route: Oral
    Start date: 1995-04-24
    End date: 1995-05-23

Possible Motrin side effects / adverse reactions in 64 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2007-05-23

Patient: 64 year old female weighing 77.1 kg (169.6 pounds)

Reactions: Blood Pressure Diastolic Increased

Suspect drug(s):
Motrin

Possible Motrin side effects / adverse reactions in 57 year old female

Reported by a individual with unspecified qualification from United States on 2007-05-25

Patient: 57 year old female

Reactions: Pneumonia Aspiration, Unresponsive TO Stimuli, Tricuspid Valve Incompetence, Somnolence, Foaming AT Mouth, Cyanosis, Sputum Culture Positive, Multiple Drug Overdose, Apnoea, Blood Glucose Increased, Blood Urea Increased, Blood Pressure Systolic Increased, Haemophilus Infection, Blood Chloride Increased, Troponin Increased, Streptococcal Infection, Aggression, Convulsion, Heart Rate Increased, Mitral Valve Incompetence

Adverse event resulted in: hospitalization

Suspect drug(s):
Soma (Carisoprodol, Usp) 350mg
    Dosage: 87 tablets (350 mg tablets), oral
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Motrin
    Dosage: 71 tablets (800 mg tablets), oral
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Buspar
    Dosage: 33 tablets (5 mg tablets), oral
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Ultram
    Dosage: 100 tablets, oral
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Lorazepam
    Dosage: 28 tablets (30mg tablets), oral
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Other drugs received by patient: Claritin; Neurontin; Celexa; Phenazopyridine HCL TAB; Dalmane; Potassium Chloride

Possible Motrin side effects / adverse reactions in 57 year old female

Reported by a lawyer from United States on 2007-06-21

Patient: 57 year old female

Reactions: Respiratory Failure, Pneumonia Streptococcal, Mitral Valve Incompetence, Troponin Increased, Sputum Culture Positive, Multiple Drug Overdose, Tricuspid Valve Incompetence

Adverse event resulted in: hospitalization

Suspect drug(s):
Buspar
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Motrin
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Ultram
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Soma
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Lorazepam
    Administration route: Oral
    Start date: 2003-06-01
    End date: 2003-06-01

Other drugs received by patient: Claritin; Neurontin; Celexa; Phenazopyridine HCL TAB; Dalmane; Potassium Chloride

Possible Motrin side effects / adverse reactions in male

Reported by a individual with unspecified qualification from United States on 2007-06-22

Patient: male weighing 2.4 kg (5.3 pounds)

Reactions: Asthma, Dysphagia, Drug Exposure During Pregnancy, Neonatal Aspiration, Congenital Nystagmus, Jaundice Neonatal

Adverse event resulted in: hospitalization

Suspect drug(s):
Rebif
    Dosage: 44 mcg, 3 in 1 weeks, subcutaneous
    Indication: Multiple Sclerosis
    Start date: 2005-06-22
    End date: 2005-08-01

Zomig
    Dosage: 2.5 mg, as required, oral
    Administration route: Oral
    End date: 2005-08-01

Motrin
    Dosage: 800 mg, as required, oral
    Administration route: Oral
    Start date: 2005-06-01
    End date: 2005-08-01

Possible Motrin side effects / adverse reactions in 31 year old female

Reported by a individual with unspecified qualification from United States on 2007-06-22

Patient: 31 year old female

Reactions: Drug Exposure During Pregnancy, Pregnancy Induced Hypertension, Premature Labour

Suspect drug(s):
Rebif
    Dosage: 44 mcg, 3 in 1 weeks, subcutaneous
    Indication: Multiple Sclerosis
    Start date: 2005-06-22
    End date: 2005-08-24

Zomig
    Dosage: 2.5 mg, as required, oral
    Administration route: Oral
    End date: 2005-08-01

Motrin
    Dosage: 800 mg, as required, oral
    Administration route: Oral
    Start date: 2005-06-01
    End date: 2005-08-01

Possible Motrin side effects / adverse reactions in 31 year old female

Reported by a individual with unspecified qualification from United States on 2007-06-27

Patient: 31 year old female

Reactions: Drug Exposure During Pregnancy, Pregnancy Induced Hypertension, Premature Labour

Suspect drug(s):
Zomig
    Administration route: Oral
    Indication: Migraine
    Start date: 2005-08-01
    End date: 2005-08-01

Rebif
    Indication: Multiple Sclerosis
    Start date: 2005-06-22
    End date: 2005-08-24

Motrin
    Indication: Premedication
    Start date: 2005-06-01
    End date: 2005-08-01