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Motrin (Ibuprofen) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Motrin (Ibuprofen) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (147)
Death (2)
Life Threatening Events (3)
Disability (12)

Reports by Reaction Type

Drug Ineffective (27)Vomiting (20)Nausea (20)Drug Hypersensitivity (18)Anxiety (18)Fatigue (16)Toxic Epidermal Necrolysis (16)Blood Glucose Increased (15)Abasia (13)Pain (13)Dyspnoea (13)Constipation (12)

Below are a few examples of reports where side effects / adverse reactions may be related to Motrin (Ibuprofen). For a complete list or a specific selection of reports, please use the links above.

Possible Motrin side effects in male

Reported by a lawyer from United States on 2012-08-27

Patient: male

Reactions: Confusional State, Anxiety, Post-Traumatic Stress Disorder, Toxic Epidermal Necrolysis, Skin Disorder, Pulmonary Oedema, Respiratory Distress, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advil
    Dosage: 200 mg, unk
    Indication: Headache
    Start date: 2010-04-20

Motrin
    Dosage: unk
    Indication: Pain

Tylenol
    Dosage: unk
    Indication: Pain



Possible Motrin side effects in 55 year old male

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient: 55 year old male, weighing 118.0 kg (259.6 pounds)

Reactions: Weight Decreased, Renal Impairment, Blood Potassium Decreased, Dehydration, Adverse Event

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
AN Unknown Medication
    Indication: Chronic Obstructive Pulmonary Disease

Fluticasone Propionate
    Indication: Chronic Obstructive Pulmonary Disease
    End date: 2010-12-01

Motrin
    Dosage: unknown dose, 6 times a day
    Indication: Pain in Extremity
    Start date: 2009-01-01

Motrin
    Dosage: unknown dose, 6 times a day
    Indication: Arthralgia
    Start date: 2009-01-01

Motrin
    Dosage: unknown dose, 6 times a day
    Indication: Back Pain
    Start date: 2009-01-01

Motrin
    Dosage: unknown dose, 6 times a day
    Start date: 2009-01-01



Possible Motrin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Abdominal Discomfort, Vomiting, Malaise, Rash

Drug(s) suspected as cause:
Ibuprofen
    Indication: Product Used FOR Unknown Indication

Motrin
    Indication: Product Used FOR Unknown Indication



Possible Motrin side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: male

Reactions: Confusional State, Anxiety, Post-Traumatic Stress Disorder, Toxic Epidermal Necrolysis, Skin Disorder, Pulmonary Oedema, Respiratory Distress, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advil
    Indication: Headache
    Start date: 2010-04-01

Motrin
    Indication: Pain

Motrin

Tylenol

Tylenol
    Indication: Pain



Possible Motrin side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Abdominal Discomfort, Vomiting, Malaise, Rash

Drug(s) suspected as cause:
Ibuprofen
    Dosage: unk

Motrin
    Dosage: unk



Possible Motrin side effects in

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient:

Reactions: Headache

Drug(s) suspected as cause:
Acetaminophen
    Dosage: unk
    Indication: Headache
    Start date: 2012-08-19

Aleve (Caplet)
    Dosage: unk
    Indication: Headache
    Start date: 2012-08-19

Motrin
    Dosage: unk
    Indication: Headache
    Start date: 2012-08-19



Possible Motrin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: female

Reactions: Abdominal Discomfort, Vomiting, Malaise, Rash

Drug(s) suspected as cause:
Ibuprofen
    Indication: Product Used FOR Unknown Indication

Motrin
    Indication: Product Used FOR Unknown Indication



Possible Motrin side effects in male

Reported by a lawyer from United States on 2012-08-14

Patient: male

Reactions: Confusional State, Anxiety, Post-Traumatic Stress Disorder, Toxic Epidermal Necrolysis, Skin Disorder, Pulmonary Oedema, Respiratory Distress, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advil
    Dosage: 200 mg, unk
    Indication: Headache
    Start date: 2010-04-20

Motrin
    Dosage: unk
    Indication: Pain

Tylenol
    Dosage: unk
    Indication: Pain



Possible Motrin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-14

Patient: female

Reactions: Abdominal Discomfort, Vomiting, Malaise, Rash

Drug(s) suspected as cause:
Ibuprofen
    Dosage: unk

Motrin
    Dosage: unk



Possible Motrin side effects in 44 year old female

Reported by a physician from United States on 2012-08-13

Patient: 44 year old female, weighing 56.2 kg (123.7 pounds)

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Codeine

Compazine
    Indication: Nausea

Droperidol
    Dosage: unk

Ibuprofen
    Dosage: 200 mg, as needed

Imitrex
    Dosage: unk
    Indication: Migraine

Inapsine

Morphine Sulfate
    Indication: Pain

Motrin
    Dosage: unk

Reglan
    Dosage: unk

Risperdal
    Dosage: unk

Sumatriptan Succinate
    Dosage: unk

Toradol



Possible Motrin side effects in 54 year old female

Reported by a physician from United States on 2012-08-13

Patient: 54 year old female, weighing 55.8 kg (122.7 pounds)

Reactions: Vomiting, Nausea, Diarrhoea, Dehydration, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aleve
    Administration route: Oral
    Indication: Pain
    Start date: 2012-06-12
    End date: 2012-06-13

Doxycycline HCL
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-05-29
    End date: 2012-06-20

Motrin
    Administration route: Oral
    Indication: Pain
    Start date: 2011-12-19
    End date: 2012-06-11

MS Contin
    Administration route: Oral
    Indication: Pain
    Start date: 2012-06-12
    End date: 2012-06-12

Unknown Medication
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-05-29
    End date: 2012-06-18

Zofran
    Indication: Nausea
    Start date: 2012-06-17
    End date: 2012-06-19

Other drugs received by patient: Vitamin B-12; Ascorbic Acid; Pamidronate Disodium; Vitamine E; Multiple Vitamin; Folic Acid; Vitamin D



Possible Motrin side effects in 31 year old male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: 31 year old male

Reactions: Dysuria

Drug(s) suspected as cause:
Aleve (Caplet)

Motrin



Possible Motrin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-09

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Hydrocodone
    Dosage: unk
    Indication: Joint Swelling

Hydrocodone
    Indication: Paraesthesia

Motrin
    Indication: Paraesthesia

Motrin
    Dosage: unk
    Indication: Joint Swelling



Possible Motrin side effects in male

Reported by a lawyer from United States on 2012-08-08

Patient: male

Reactions: Confusional State, Anxiety, Post-Traumatic Stress Disorder, Skin Disorder, Toxic Epidermal Necrolysis, Pulmonary Oedema, Respiratory Distress, Stevens-Johnson Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Advil
    Indication: Headache
    Start date: 2010-04-01

Motrin

Motrin
    Indication: Pain

Tylenol

Tylenol
    Indication: Pain



Possible Motrin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: female, weighing 73.5 kg (161.7 pounds)

Reactions: Liver Injury, Vitamin D Deficiency, Hepatic Pain, Urticaria, Anxiety, Weight Increased, Systemic Lupus Erythematosus, Blood Cholesterol Increased, Drug Administration Error

Drug(s) suspected as cause:
Acetaminophen
    Dosage: 1 caplet nightly at bedtime for about 4 months
    Administration route: Oral
    Indication: Sleep Disorder Therapy

Acetaminophen
    Dosage: 1 caplet nightly at bedtime for about 4 months
    Administration route: Oral
    Indication: Pain

Advil
    Dosage: 3-4 daily for few months 2-3 years ago
    Indication: Pain

Chantix
    Dosage: for 3 weeks 3-4 years ago
    Administration route: Oral
    Indication: Smoking Cessation Therapy

Extra Strength Tylenol
    Dosage: 2 caplets every 6 hours while awake for 8 months 2-3 years ago
    Administration route: Oral
    Indication: Pain

Ibuprofen
    Indication: Pain

Motrin
    Indication: Pain

Naproxen (Aleve)
    Dosage: 1 occasionally for few months 2-3 years ago
    Indication: Pain

Tylenol (Caplet)
    Dosage: 1-2 tablets every 6 hours while awake for 3 weeks
    Administration route: Oral
    Indication: Pain



Possible Motrin side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient: 55 year old female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Codeine Sulfate
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Motrin
    Dosage: unk



Possible Motrin side effects in

Reported by a consumer/non-health professional from United States on 2012-08-08

Patient:

Reactions: Pain

Drug(s) suspected as cause:
Aleve (Caplet)
    Indication: Pain

Motrin
    Indication: Pain

Vicodin
    Indication: Pain



Possible Motrin side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Back Pain, Vomiting, Dyspnoea, Nausea, Drug Hypersensitivity, Abasia, Constipation, Skin Irritation, Myalgia, Fatigue, Insomnia, Asthenia, Blood Glucose Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Coreg

Glucophage

Ibuprofen (Advil)

Lipitor

Lotrimin

Luvox

Metformin Hydrochloride

Metoprolol Tartrate

Motrin

Plavix

Proscar

Prozac

Reglan

Restasis

Toprol-XL

Tramadol Hydrochloride

Viagra

Xalatan

Zetia

Zocor

Other drugs received by patient: Allopurinol; Omega-3-Acid Ethyl Esters; Pilocarpine; Istalol; Clozapine; Bilberry; Oxycodone HCL; Aspirin; Potassium Chloride; Lumigan; Pravastatin Sodium; Furosemide; Vicodin; Losartan Potassium; Digoxin; Folic Acid; Theratears; Diazepam; Lantus



Possible Motrin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient:

Reactions: Back Pain, Dyspnoea, HIP Arthroplasty, Vomiting, Nausea, Abasia, Drug Hypersensitivity, Constipation, Skin Irritation, Myalgia, Fatigue, Sleep Disorder, Asthenia, Blood Glucose Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Alprazolam

Codeine

Coreg

Cyclosporine

Glucophage

Ibuprofen (Advil)
    Dosage: 200 mg, prn

Lipitor

Lotrimin

Luvox

Metformin Hydrochloride
    Dosage: 500 mg, unk

Metoprolol Tartrate
    Dosage: 25 mg, bid

Motrin

Plavix

Proscar
    Administration route: Oral

Prozac

Reglan

Toprol-XL

Tramadol Hydrochloride

Viagra

Xalatan

Zetia
    Administration route: Oral

Zocor
    Administration route: Oral

Other drugs received by patient: Folic Acid; Pilocarpine; Timolol Maleate; Lantus; Lumigan; Pravastatin Sodium; Thera Tears; Potassium Chloride - USP; Vicodin; Digoxin; Aspirin; Diazepam; Furosemide; Cozaar; Bilberry; Oxycodone HCL; Aspirin; Omega-3 Marine Triglycerides; Clozapine; Allopurinol



Possible Motrin side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: female, weighing 73.5 kg (161.7 pounds)

Reactions: Vitamin D Deficiency, Liver Injury, Hepatic Pain, Urticaria, Weight Increased, Anxiety, Systemic Lupus Erythematosus, Blood Cholesterol Increased, Drug Administration Error

Drug(s) suspected as cause:
Chantix
    Dosage: for 3 weeks 3-4 years ago
    Administration route: Oral
    Indication: Smoking Cessation Therapy

Extra Strength Tylenol
    Dosage: 2 caplets every 6 hours while awake for 8 months 2-3 years ago
    Administration route: Oral
    Indication: Pain

Ibuprofen
    Indication: Pain

Ibuprofen (Advil)
    Dosage: 3-4 daily for few months 2-3 years ago
    Indication: Pain

Motrin
    Indication: Pain

Naproxen (Aleve)
    Dosage: 1 occasionally for few months 2-3 years ago
    Indication: Pain

Tylenol
    Dosage: 1 caplet nightly at bedtime for about 4 months
    Administration route: Oral
    Indication: Sleep Disorder Therapy

Tylenol
    Dosage: 1 caplet nightly at bedtime for about 4 months
    Administration route: Oral
    Indication: Pain

Tylenol (Caplet)
    Dosage: 1-2 tablets every 6 hours while awake for 3 weeks
    Administration route: Oral
    Indication: Pain



Possible Motrin side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-01

Patient: male, weighing 84.8 kg (186.6 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Blood Urine Present, Diarrhoea, Musculoskeletal Pain, Headache, Blood Glucose Increased

Drug(s) suspected as cause:
Motrin
    Indication: Musculoskeletal Pain

Motrin
    Dosage: 400 mg, 1x/day
    Administration route: Oral
    Indication: Headache
    Start date: 2012-01-01

Xarelto
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Indication: Atrial Fibrillation
    Start date: 2012-06-29
    End date: 2012-07-02

Xarelto
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Start date: 2012-07-01

Other drugs received by patient: Metoprolol Tartrate; Potassium; Furosemide; Cardura; Metoprolol Tartrate; Metoprolol Tartrate; Cardura; Androgel; Digoxin



Possible Motrin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Back Pain, Vomiting, Dyspnoea, HIP Arthroplasty, Nausea, Abasia, Drug Hypersensitivity, Constipation, Skin Irritation, Myalgia, Fatigue, Sleep Disorder, Asthenia, Blood Glucose Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Alprazolam

Codeine

Coreg

Cyclosporine

Glucophage

Ibuprofen (Advil)
    Dosage: unk, prn

Lipitor

Lotrimin

Luvox

Metformin Hydrochloride

Metoprolol Tartrate
    Dosage: unk, qd

Motrin

Motrin
    Dosage: unk, prn

Plavix

Proscar
    Administration route: Oral

Prozac

Reglan

Toprol-XL

Tramadol Hydrochloride

Viagra

Xalatan

Zetia
    Administration route: Oral

Zocor
    Administration route: Oral

Other drugs received by patient: Timolol Maleate; Thera Tears; Clozapine; Omega-3 Marine Triglycerides; Aspirin; Losartan Potassium; Allopurinol; Lantus; Potassium Chloride; Pravastatin Sodium; Digoxin; Diazepam; Bilberry; Lumigan; Folic Acid; Furosemide; Oxycodone HCL; Pilocarpine; Acetaminophen / Hydrocodone Bitartrate



Possible Motrin side effects in 38 year old female

Reported by a physician from United States on 2012-07-31

Patient: 38 year old female

Reactions: Rectal Haemorrhage, Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brivanib
    Dosage: unspecified
    Indication: Adenocarcinoma of THE Cervix
    Start date: 2012-06-21
    End date: 2012-06-28

Motrin
    Dosage: 800 mg, as needed
    Administration route: Oral
    Indication: Pain Prophylaxis



Possible Motrin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Back Pain, Dyspnoea, Vomiting, Nausea, Abasia, Constipation, Skin Irritation, Myalgia, Fatigue, Sleep Disorder, Asthenia, Blood Glucose Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Alprazolam

Clozapine

Codeine

Coreg

Cyclosporine

Glucophage

Ibuprofen (Advil)

Lipitor

Lotrimin AF

Lumigan

Luvox

Metformin Hydrochloride
    Dosage: 500 mg, unk

Metoprolol Tartrate
    Dosage: 25 mg, bid
    Administration route: Oral

Motrin

Oxycodone HCL

Plavix

Pravastatin Sodium

Proscar
    Administration route: Oral

Prozac

Reglan

Toprol-XL

Tramadol Hydrochloride

Viagra

Vicodin

Xalatan
    Dosage: 200 mg, prn

Zetia
    Administration route: Oral

Zocor
    Administration route: Oral

Other drugs received by patient: Losartan Potassium; Thera Tears; Folic Acid; Digoxin; Bilberry; Omega-3 Marine Triglycerides; Pilocarpine; Furosemide; Diazepam; Istalol; Lantus; Allopurinol; Potassium Chloride; Aspirin



Possible Motrin side effects in 38 year old female

Reported by a physician from United States on 2012-07-25

Patient: 38 year old female

Reactions: Anaemia, Rectal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Brivanib
    Indication: Adenocarcinoma of THE Cervix
    Start date: 2012-06-21
    End date: 2012-06-28

Motrin
    Administration route: Oral
    Indication: Pain Prophylaxis



Possible Motrin side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-25

Patient: female, weighing 78.9 kg (173.6 pounds)

Reactions: Drug Ineffective, Pain, Swelling

Drug(s) suspected as cause:
Lyrica
    Dosage: 225 mg, 3x/day
    Indication: Fibromyalgia
    End date: 2012-04-01

Motrin
    Dosage: 800 mg, as needed
    Indication: Pain

Other drugs received by patient: Risperidone; Chondroitin / Glucosamine; Trileptal; Iron; Colace; Premarin; Magnesium; Omeprazole; Lopressor; Diazepam; Lisinopril



Possible Motrin side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-20

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Product Quality Issue, Chest Discomfort, Drug Ineffective, Chest Pain

Drug(s) suspected as cause:
Motrin
    Dosage: unk
    Start date: 2012-06-01

Protonix
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2007-01-01

Protonix
    Dosage: 40 mg, daily
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-06-01

Other drugs received by patient: Lithium; Fuzeon; Thorazine; Lamictal; Synthroid; Lorazepam; Combivent; Advair Diskus 100 / 50



Possible Motrin side effects in 60 year old male

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 60 year old male, weighing 162.0 kg (356.4 pounds)

Reactions: Weight Increased, Tooth Fracture, Rash, Blood Glucose Increased

Drug(s) suspected as cause:
Coumadin

Glucotrol XL
    Dosage: tab
    Administration route: Oral
    Indication: Diabetes Mellitus
    Start date: 2000-01-01

Motrin
    Dosage: tabs
    Administration route: Oral
    Indication: Arthritis

Vancomycin

Other drugs received by patient: Codeine; Amiodarone HCL; Amiodarone HCL; Percocet; Tylenol; Tylenol



Possible Motrin side effects in 41 year old male

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: 41 year old male

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Advil
    Dosage: unk

Motrin
    Dosage: unk



Possible Motrin side effects in 54 year old female

Reported by a physician from United States on 2012-07-17

Patient: 54 year old female, weighing 55.8 kg (122.7 pounds)

Reactions: Vomiting, Diarrhoea, Nausea, Dehydration, Blood Creatine Increased, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Aleve
    Dosage: 220 mg, bid
    Administration route: Oral
    Indication: Pain
    Start date: 2012-06-12
    End date: 2012-06-13

Doxycycline
    Dosage: 100 mg, bid
    Administration route: Oral
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-05-29
    End date: 2012-06-20

Motrin
    Dosage: 800 mg, bid
    Administration route: Oral
    Indication: Pain
    Start date: 2011-12-19
    End date: 2012-06-12

MS Contin
    Dosage: 15 mg, bid
    Administration route: Oral
    Indication: Pain
    Start date: 2012-06-12
    End date: 2012-06-12

Study Drug
    Dosage: 45 mg, unk
    Indication: non-Small Cell Lung Cancer
    Start date: 2012-05-29
    End date: 2012-06-18

Zofran
    Dosage: 4 mg, q6h
    Indication: Nausea
    Start date: 2012-06-17
    End date: 2012-06-19

Other drugs received by patient: Theragran-M / 00610701 /; Vitamin D; Folic Acid; B12 / 00056201 /; Vitamin C / 00008001 /; Pamidronate Disodium; Vitamin E / 00110501 /

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