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Naproxen (Naproxen) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Naproxen 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 (784)
Death (188)
Life Threatening Events (80)
Disability (20)

Reports by Reaction Type

Completed Suicide (120)Gastrointestinal Haemorrhage (71)Haemoglobin Decreased (51)Toxicity To Various Agents (46)Dizziness (40)Nausea (39)Gastric Ulcer (38)Diarrhoea (36)Cardiac Arrest (33)Dyspnoea (31)Rash (30)Haematemesis (28)

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

Possible Naproxen side effects in 66 year old female

Reported by a pharmacist from United Kingdom on 2012-08-27

Patient: 66 year old female, weighing 110.0 kg (242.0 pounds)

Reactions: Duodenal Ulcer Haemorrhage

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Naproxen

Other drugs received by patient: Bendroflumethiazide; Bisoprolol Fumarate; Dothiepin Hydrochloride; Ramipril



Possible Naproxen side effects in female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-26

Patient: female

Reactions: Movement Disorder, Pain, Rash, Abdominal Pain Upper, Diarrhoea, Swelling, DRY Mouth, Feeling Hot, Insomnia, Salmonellosis, Gait Disturbance, Blister

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Naproxen
    Dosage: 2 df, unk
    Indication: Inflammation
    Start date: 2012-07-01
    End date: 2012-07-14

Voltaren
    Dosage: applied no more than 6 times
    Administration route: Topical
    Indication: Inflammation
    Start date: 2012-07-14
    End date: 2012-07-17

Other drugs received by patient: Omeprazole



Possible Naproxen side effects in female

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

Patient: female

Reactions: Movement Disorder, Pain, Rash, Abdominal Pain Upper, Diarrhoea, Feeling Hot, DRY Mouth, Insomnia, Swelling, Salmonellosis, Gait Disturbance, Blister

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Naproxen
    Dosage: 1 df, unk
    Administration route: Oral
    Indication: Inflammation
    Start date: 2012-07-01
    End date: 2012-07-14

Naproxen
    Indication: Pain

Voltaren
    Indication: Pain

Voltaren
    Dosage: bid
    Administration route: Topical
    Indication: Inflammation
    Start date: 2012-07-14
    End date: 2012-07-17

Other drugs received by patient: Omeprazole



Possible Naproxen side effects in 80 year old female

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

Patient: 80 year old female

Reactions: Thrombosis, Fluid Overload, Dyspnoea, Vomiting, Tachycardia, Gastric Ulcer Haemorrhage, Hyperhidrosis, Abdominal Pain Upper, Haemodynamic Instability, Haematochezia, Cardio-Respiratory Arrest, Tachypnoea, Melaena, Blood Pressure Decreased

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Naproxen



Possible Naproxen side effects in 62 year old male

Reported by a physician from France on 2012-08-24

Patient: 62 year old male

Reactions: Drug Interaction, Status Epilepticus

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naproxen

Other drugs received by patient possibly interacting with the suspect drug:
Depakene
    Administration route: Oral
    Start date: 2011-01-01

Depakene
    Administration route: Oral
    Indication: Idiopathic Generalised Epilepsy
    Start date: 2009-01-01

Nexium
    Administration route: Oral
    Indication: Antiinflammatory Therapy
    Start date: 2011-09-23
    End date: 2011-09-23



Possible Naproxen side effects in 33 year old male

Reported by a physician from United States on 2012-08-24

Patient: 33 year old male

Reactions: Kounis Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naproxen



Possible Naproxen side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-08-23

Patient:

Reactions: Haemorrhage, Drug Interaction

Adverse event resulted in: death, hospitalization

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

Amoxicillin and Clavulanate Potassium
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Ciprofloxacin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Clopidegrel
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Diclofenac Sodium
    Indication: Product Used FOR Unknown Indication

Ibuprofen
    Indication: Product Used FOR Unknown Indication

Ketoprofen
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Levofloxacin
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Marcumar
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Metronidazole
    Indication: Product Used FOR Unknown Indication

Moxifloxacin
    Indication: Product Used FOR Unknown Indication

Naproxen
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Ofloxacin
    Indication: Product Used FOR Unknown Indication

Sulfamethoxazole Trimethoprim
    Dosage: unk
    Indication: Product Used FOR Unknown Indication



Possible Naproxen side effects in 33 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: 33 year old male

Reactions: Kounis Syndrome

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Naproxen



Possible Naproxen side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient:

Reactions: Adverse Event, Toxic Epidermal Necrolysis, Stevens-Johnson Syndrome

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

Darunavir Ethanolate
    Indication: Product Used FOR Unknown Indication

Erythromycin
    Indication: Product Used FOR Unknown Indication

Famotidine
    Indication: Product Used FOR Unknown Indication

Fluconazole
    Indication: Product Used FOR Unknown Indication

Griseofulvin
    Indication: Product Used FOR Unknown Indication

Indomethacin
    Indication: Product Used FOR Unknown Indication

Ketoprofen
    Indication: Product Used FOR Unknown Indication

Levofloxacin
    Indication: Product Used FOR Unknown Indication

Naproxen
    Indication: Product Used FOR Unknown Indication

Ofloxacin
    Indication: Product Used FOR Unknown Indication

Tramadol HCL
    Indication: Product Used FOR Unknown Indication



Possible Naproxen side effects in 33 year old male

Reported by a physician from United States on 2012-08-21

Patient: 33 year old male

Reactions: Kounis Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naproxen



Possible Naproxen side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-21

Patient: female

Reactions: Movement Disorder, Pain, Rash, Abdominal Pain Upper, Diarrhoea, Feeling Hot, DRY Mouth, Swelling, Insomnia, Salmonellosis, Gait Disturbance, Blister

Drug(s) suspected as cause:
Naproxen
    Indication: Inflammation
    Start date: 2012-07-01
    End date: 2012-07-14

Voltarol Emulgel
    Administration route: Topical
    Indication: Inflammation
    Start date: 2012-07-14
    End date: 2012-07-17

Other drugs received by patient: Omeprazole



Possible Naproxen side effects in 76 year old female

Reported by a pharmacist from United States on 2012-08-20

Patient: 76 year old female

Reactions: Blood Urine Present

Drug(s) suspected as cause:
Naproxen

Other drugs received by patient: Toprol-XL; Tylenol; Multi-Vitamin; Maxzide; Senna; Miralax; Dilaudid; Megace; Iron Supplement; Sutent



Possible Naproxen side effects in 40 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-20

Patient: 40 year old female, weighing 69.9 kg (153.8 pounds)

Reactions: Burning Sensation, Abdominal Pain, Diarrhoea, Swelling, Abdominal Distension

Drug(s) suspected as cause:
Naproxen

Other drugs received by patient: Plavix



Possible Naproxen side effects in male

Reported by a consumer/non-health professional from Israel on 2012-08-17

Patient: male

Reactions: Rash, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Esomeprazole Sodium
    Dosage: one dosage unit (total)
    Indication: Pharyngitis
    Start date: 2012-07-03
    End date: 2012-07-03

Naproxen
    Dosage: one dosage unit (total)
    Administration route: Oral
    Indication: Pharyngitis
    Start date: 2012-07-03
    End date: 2012-07-03



Possible Naproxen side effects in 60 year old female

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

Patient: 60 year old female

Reactions: Toxic Epidermal Necrolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naproxen



Possible Naproxen side effects in male

Reported by a consumer/non-health professional from Italy on 2012-08-17

Patient: male

Reactions: Pyrexia, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Esomeprazole Sodium
    Dosage: one dosage unit (total)
    Indication: Pharyngitis
    Start date: 2012-07-03
    End date: 2012-07-03

Naproxen
    Dosage: one dosage unit (total)
    Administration route: Oral
    Indication: Pharyngitis
    Start date: 2012-07-03
    End date: 2012-07-03



Possible Naproxen side effects in 40 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-16

Patient: 40 year old female, weighing 69.8 kg (153.7 pounds)

Reactions: Abdominal Pain, Burning Sensation, Diarrhoea, Swelling, Abdominal Distension

Drug(s) suspected as cause:
Naproxen

Other drugs received by patient: Plavix



Possible Naproxen side effects in male

Reported by a physician from Argentina on 2012-08-15

Patient: male

Reactions: Renal Tubular Necrosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adalimumab OR Placebo
    Dosage: 40 milligram daily;
    Indication: Rheumatoid Arthritis
    Start date: 2012-04-09
    End date: 2012-06-05

BMS 945429 OR Placebo
    Indication: Rheumatoid Arthritis
    Start date: 2012-04-09

Methotrexate
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2012-04-09

Naproxen
    Dosage: 1000 milligram daily;
    Indication: Rheumatoid Arthritis

Other drugs received by patient: Prednisone TAB; Folic Acid



Possible Naproxen side effects in 57 year old female

Reported by a physician from United States on 2012-08-15

Patient: 57 year old female, weighing 69.0 kg (151.8 pounds)

Reactions: Gastrooesophageal Reflux Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded NO Subject Drug
    Dosage: thrice a day
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2012-03-07

Blinded NO Subject Drug
    Indication: Rheumatoid Arthritis

Celecoxib
    Indication: Rheumatoid Arthritis

Celecoxib
    Dosage: thrice a day
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2012-03-07

Ibuprofen
    Dosage: thrice a day
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2012-03-07

Ibuprofen
    Indication: Rheumatoid Arthritis

Ibuprofen

Ibuprofen
    Dosage: 200 mg, as needed
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2012-07-01

Ibuprofen
    Dosage: thrice a day
    Administration route: Oral
    Start date: 2012-03-07

Naproxen
    Indication: Rheumatoid Arthritis

Naproxen

Naproxen
    Dosage: thrice a day
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2012-03-07

Naproxen
    Dosage: thrice a day
    Administration route: Oral
    Start date: 2012-03-07

Placebo
    Indication: Rheumatoid Arthritis

Placebo
    Dosage: thrice a day
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2012-03-07

Other drugs received by patient: Nexium



Possible Naproxen side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-08-15

Patient: male, weighing 42.0 kg (92.4 pounds)

Reactions: Phlebitis, Off Label Use, Thrombosis, Tachycardia, Dizziness

Drug(s) suspected as cause:
Naproxen
    Indication: Thrombosis

Xarelto
    Administration route: Oral
    Indication: Deep Vein Thrombosis
    Start date: 2012-04-25
    End date: 2012-05-04

Other drugs received by patient: Warfarin Sodium; Acetaminophen; Dipyrone INJ



Possible Naproxen side effects in 18 year old female

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

Patient: 18 year old female, weighing 69.3 kg (152.6 pounds)

Reactions: Pneumonia, Respiratory Disorder, Urinary Tract Infection, Toxic Epidermal Necrolysis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lamictal
    Indication: Anger

Lamictal
    Indication: Bipolar I Disorder

Lamictal
    Dosage: 50 mg, extended tab
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-02-23
    End date: 2012-03-08

Naproxen
    Dosage: 500 mg, as needed
    Indication: Ligament Sprain
    Start date: 2012-02-22

Zithromax
    Dosage: 250 mg, daily (2 on 1st day and once daily for 4 days): duration of treatment: 5 days
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2012-03-07
    End date: 2012-03-09

Other drugs received by patient: Flexeril



Possible Naproxen side effects in 18 year old female

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

Patient: 18 year old female, weighing 69.3 kg (152.6 pounds)

Reactions: Pneumonia, Respiratory Disorder, Urinary Tract Infection, Toxic Epidermal Necrolysis

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Lamictal
    Dosage: 50 mg, extended tab
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-02-23
    End date: 2012-03-08

Lamictal
    Indication: Bipolar I Disorder

Lamictal
    Indication: Anger

Naproxen
    Dosage: 500 mg, as needed
    Indication: Ligament Sprain
    Start date: 2012-02-22

Zithromax
    Dosage: 250 mg, daily (2 on 1st day and once daily for 4 days): duration of treatment: 5 days
    Administration route: Oral
    Indication: Sinusitis
    Start date: 2012-03-07
    End date: 2012-03-09

Other drugs received by patient: Flexeril



Possible Naproxen side effects in 33 year old male

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

Patient: 33 year old male

Reactions: Electrocardiogram ST Segment Depression, Angina Pectoris, Hypotension, Kounis Syndrome, Dizziness, Rash Maculo-Papular, Myocardial Infarction, Rash Pruritic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naproxen



Possible Naproxen side effects in 66 year old male

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

Patient: 66 year old male, weighing 60.7 kg (133.5 pounds)

Reactions: Haemoglobin Decreased, Gastrointestinal Haemorrhage, Haematocrit Decreased, Dialysis, Duodenal Ulcer Haemorrhage, Gastric Haemorrhage

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Naproxen



Possible Naproxen side effects in 69 year old male

Reported by a pharmacist from Israel on 2012-08-14

Patient: 69 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: Haemoglobin Decreased, Duodenal Ulcer Perforation, Melaena

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naproxen

Other drugs received by patient: Baclofen; Zopiclone; Fentanyl; Pregabalin



Possible Naproxen side effects in 75 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-13

Patient: 75 year old male

Reactions: Blood Creatinine Increased, Renal Failure Acute, Anuria

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naproxen

Other drugs received by patient: Finasteride; Simvastatin; Warfarin Sodium; Alfuzosin; Metformin Hydrochloride; Omeprazole



Possible Naproxen side effects in 40 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-13

Patient: 40 year old female, weighing 69.8 kg (153.7 pounds)

Reactions: Burning Sensation, Abdominal Pain, Diarrhoea, Swelling, Abdominal Distension

Drug(s) suspected as cause:
Naproxen

Other drugs received by patient: Plavix



Possible Naproxen side effects in 75 year old male

Reported by a pharmacist on 2012-08-09

Patient: 75 year old male

Reactions: Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naproxen

Other drugs received by patient: Metfformin Hydrochloride; Warfarin Sodium; Omeprazole; Finasteride; Alfuzosin HCL; Simvastatin



Possible Naproxen side effects in 69 year old male

Reported by a pharmacist from United Kingdom on 2012-08-09

Patient: 69 year old male, weighing 83.0 kg (182.6 pounds)

Reactions: Duodenal Ulcer Perforation, Haemoglobin Decreased, Melaena

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naproxen

Other drugs received by patient: Fentanyl; Pregabalin; Baclofen; Zopiclone Alpharma



Possible Naproxen side effects in 96 year old male

Reported by a physician from United States on 2012-08-09

Patient: 96 year old male

Reactions: Abdominal Discomfort, Drug Ineffective, Gout, Diarrhoea, Diarrhoea Haemorrhagic, Laceration, Condition Aggravated, Abdominal Pain Upper

Drug(s) suspected as cause:
Flector
    Indication: Pain in Extremity

Flector
    Dosage: unk
    Indication: Swelling

Flector
    Dosage: unk
    Indication: Arthralgia
    Start date: 2012-06-19

Naproxen
    Dosage: 500 mg, unk

Naproxen
    Dosage: 500 ml, 2x/day
    Start date: 2012-06-18

Other drugs received by patient: Diovan HCT; Levothyroxine; Xanax; Plavix; Lipitor; Hydroxyurea; Zegerid

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