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Naprosyn (Naproxen) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Naprosyn (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 (63)
Death (1)
Life Threatening Events (5)
Disability (2)

Reports by Reaction Type

Abdominal Discomfort (10)Abdominal Pain (8)Drug Ineffective (8)Pain (8)Nausea (8)Drug Hypersensitivity (8)Pain in Extremity (7)Abdominal Pain Upper (6)Malaise (5)Oedema Peripheral (5)Dizziness (5)Arthralgia (5)

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

Possible Naprosyn side effects in 59 year old

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: 59 year old

Reactions: Drug Hypersensitivity

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

Septra
    Dosage: unk

Phenylephrine Hydrochloride
    Dosage: unk

Chlorpheniramine Maleate
    Dosage: unk

Albuterol Sulfate
    Dosage: unk

Bactrim
    Dosage: unk

Tetracycline Hydrochloride
    Dosage: unk

Chlorpheniramine Maleate
    Dosage: unk

Triprolidine Hydrochloride
    Dosage: unk

Leflunomide
    Dosage: unk

Ceclor
    Dosage: unk

Amlodipine Besylate
    Dosage: unk

Celebrex
    Dosage: unk

Meclizine HCL
    Dosage: unk

Phenylpropanolamine HCL
    Dosage: unk

Naprosyn
    Dosage: unk

Gemifloxacin Mesylate
    Dosage: unk

Sulfanilamide
    Dosage: unk

Astemizole
    Dosage: unk

Lodine
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Fosinopril Sodium
    Dosage: unk

Fluticasone Propionate
    Dosage: unk

Cefadroxil
    Dosage: unk

Cefuroxime
    Dosage: unk

Dexchlorpheniramine Maleate
    Dosage: unk

Moxifloxacin Hydrochloride
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Theophylline
    Dosage: unk

Pseudoephedrine Hydrochloride
    Dosage: unk

Pseudoephedrine Sulfate
    Dosage: unk

Codeine Phosphate
    Dosage: unk

Demerol
    Dosage: unk

Acetaminophen
    Dosage: unk

Oxymetazoline HCL
    Dosage: unk

Methscopolamine Bromide
    Dosage: unk

Phenyltoloxamine
    Dosage: unk

Cromolyn Sodium
    Dosage: unk

Caffeine Citrate
    Dosage: unk

Aspirin
    Dosage: unk



Possible Naprosyn side effects in male

Reported by a consumer/non-health professional from Ireland on 2012-08-27

Patient: male

Reactions: Renal Impairment

Drug(s) suspected as cause:
Naprosyn

Other drugs received by patient: Lyrica



Possible Naprosyn side effects in 74 year old female

Reported by a physician from United States on 2012-08-23

Patient: 74 year old female

Reactions: Drug Hypersensitivity

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

Feldene
    Dosage: unk

Naprosyn
    Dosage: unk



Possible Naprosyn side effects in female

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

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Abdominal Pain, Weight Decreased, Dyspnoea, Lung Infection, Abdominal Pain Upper, Injection Site Pruritus, Pericardial Effusion, Abdominal Discomfort, Fatigue, Injection Site Erythema, Gastrointestinal Pain, Diarrhoea, Dyspepsia, Tooth Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Mobic
    Indication: Back Pain

Piroxicam

Sulfasalazine
    Indication: Ankylosing Spondylitis

Naprosyn
    Dosage: 1000 mg

Enbrel
    Indication: Ankylosing Spondylitis

Mobic
    Dosage: 15 mg
    Administration route: Oral
    Indication: Sciatica
    Start date: 2011-08-28
    End date: 2011-09-06

Naprosyn

Corticosteroids
    Indication: Ankylosing Spondylitis

Other drugs received by patient: Tramadol HCL



Possible Naprosyn side effects in 59 year old

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 59 year old

Reactions: Drug Hypersensitivity

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

Pseudoephedrine HCL
    Dosage: unk

Triprolidine HCL
    Dosage: unk

Cromolyn Sodium
    Dosage: unk

Fluticasone Propionate
    Dosage: unk

Cefadroxil
    Dosage: unk

Cefuroxime Axetil
    Dosage: unk

Tetracycline Hydrochloride
    Dosage: unk

Phenyltoloxamine
    Dosage: unk

Leflunomide
    Dosage: unk

Codeine Phosphate
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Ceclor
    Dosage: unk

Amlodipine Besylate
    Dosage: unk

Septra
    Dosage: unk

Lodine
    Dosage: unk

Theophylline
    Dosage: unk

Fosinopril Sodium
    Dosage: unk

Phenylephrine Hydrochloride
    Dosage: unk

Morphine
    Dosage: unk

Methscopolamine Bromide
    Dosage: unk

Chlorpheniramine Maleate
    Dosage: unk

Demerol
    Dosage: unk

Naprosyn
    Dosage: unk

Pseudoephedrine Sulfate
    Dosage: unk

Methotrexate
    Dosage: unk

Aspirin
    Dosage: unk

Oxymetazoline HCL
    Dosage: unk

Celebrex
    Dosage: unk

Chlorpheniramine Maleate
    Dosage: unk

Dexchlorpheniramine Maleate
    Dosage: unk

Phenylpropanolamine HCL
    Dosage: unk

Gemifloxacin Mesylate
    Dosage: unk

Albuterol Sulfate
    Dosage: unk

Astemizole
    Dosage: unk

Meclizine
    Dosage: unk

Moxifloxacin Hydrochloride
    Dosage: unk

Caffeine Citrate
    Dosage: unk

Bactrim
    Dosage: unk

Acetaminophen
    Dosage: unk



Possible Naprosyn side effects in

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

Patient:

Reactions: Anxiety, Abdominal Pain, Nausea, Drug Hypersensitivity, Musculoskeletal Pain, Depression, Gastrooesophageal Reflux Disease, Muscle Spasms

Drug(s) suspected as cause:
Aldactone
    Dosage: 25 mg, qd
    Administration route: Oral

Buspar
    Dosage: 15 mg, qd

Buspar

Nexium
    Dosage: 40 mg, qd

Naprosyn
    Dosage: 500 mg, bid

Zocor
    Dosage: 20 mg, qd
    Administration route: Oral



Possible Naprosyn side effects in 82 year old male

Reported by a pharmacist from United States on 2012-07-27

Patient: 82 year old male, weighing 87.3 kg (192.0 pounds)

Reactions: Diverticulum Intestinal Haemorrhagic, Upper Gastrointestinal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naprosyn
    Dosage: 500 mg bid, po
    Administration route: Oral
    Indication: Arthritis

Prednisone TAB
    Dosage: 30 mg daily, po
    Administration route: Oral
    Indication: Interstitial Lung Disease

Aspirin
    Dosage: 81mg daily, po
    Administration route: Oral
    Indication: Coronary Artery Disease

Other drugs received by patient: Simvastatin; M.v.i.; Bactrim DS; Terazosin Hydrochloride; Ambien; Omeprazole



Possible Naprosyn side effects in male

Reported by a health professional (non-physician/pharmacist) from Italy on 2012-07-24

Patient: male

Reactions: Tinnitus, Fatigue, Palpitations, Duodenal Ulcer Haemorrhage, Depressed Level of Consciousness, Haemorrhagic Anaemia, Melaena

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naprosyn

Other drugs received by patient: Telmisartan and Hydrochlorothiazide



Possible Naprosyn side effects in 49 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-27

Patient: 49 year old female

Reactions: Weight Decreased, Abdominal Pain, Dyspnoea, Lung Infection, Injection Site Pruritus, Pericardial Effusion, Fatigue, Injection Site Erythema, Tooth Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naprosyn
    Indication: Ankylosing Spondylitis

Mobic
    Indication: Ankylosing Spondylitis

Sulfasalazine
    Indication: Ankylosing Spondylitis

Piroxicam
    Indication: Ankylosing Spondylitis

Corticosteroids
    Indication: Ankylosing Spondylitis

Enbrel
    Indication: Ankylosing Spondylitis



Possible Naprosyn side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-06-14

Patient: 71 year old female

Reactions: Muscle Spasms

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

Daypro
    Dosage: unk

Other drugs received by patient: Levothyroxine Sodium; Prilosec



Possible Naprosyn side effects in male

Reported by a consumer/non-health professional from Brazil on 2012-06-05

Patient: male, weighing 74.0 kg (162.8 pounds)

Reactions: Diplopia, Vision Blurred, Eye Movement Disorder, Eye Pain

Drug(s) suspected as cause:
Naprosyn



Possible Naprosyn side effects in 72 year old female

Reported by a pharmacist from United States on 2012-06-01

Patient: 72 year old female

Reactions: Anaphylactic Reaction

Adverse event resulted in: hospitalization

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

Ciprofloxacin
    Indication: Product Used FOR Unknown Indication



Possible Naprosyn side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-28

Patient: male

Reactions: Renal Disorder, Glomerular Filtration Rate Abnormal, Urine Abnormality, Blood Creatinine Increased, Ill-Defined Disorder

Drug(s) suspected as cause:
Naprosyn
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-01

Lyrica
    Indication: Back Pain
    Start date: 2008-01-01



Possible Naprosyn side effects in 73 year old male

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-17

Patient: 73 year old male

Reactions: Abdominal Pain, Dizziness, Duodenal Ulcer, Small Intestinal Haemorrhage, Pallor, Lethargy, Faeces Discoloured

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naprosyn
    Administration route: Oral
    Indication: Arthritis
    Start date: 2012-04-01
    End date: 2012-04-22

Naprosyn
    Indication: Procedural Pain



Possible Naprosyn side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-16

Patient: male

Reactions: Urine Analysis Abnormal, Lactose Intolerance, Renal Disorder, Glomerular Filtration Rate Decreased, Blood Creatinine Increased

Drug(s) suspected as cause:
Naprosyn
    Indication: Back Pain

Naprosyn
    Dosage: unk
    Indication: Arthritis

Lyrica
    Dosage: unk
    Administration route: Oral
    Indication: Back Disorder
    Start date: 2008-01-01



Possible Naprosyn side effects in 71 year old female

Reported by a consumer/non-health professional from United States on 2012-05-09

Patient: 71 year old female

Reactions: Malaise, Gastrointestinal Ulcer Haemorrhage, Band Sensation, Vascular Stenosis, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naprosyn
    Start date: 2012-02-01

Rebif
    Indication: Multiple Sclerosis
    Start date: 2011-04-04

Coumadin



Possible Naprosyn side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-05-09

Patient: female, weighing 72.0 kg (158.4 pounds)

Reactions: Haematochezia, Malaise, Oesophagitis, Pain in Extremity, Retching, Gait Disturbance, Gastritis, Abdominal Pain Upper

Drug(s) suspected as cause:
Naprosyn

Other drugs received by patient: Mesigyna



Possible Naprosyn side effects in male

Reported by a physician from United States on 2012-05-08

Patient: male

Reactions: Drug Ineffective

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

Percocet
    Dosage: unk

Naprosyn
    Dosage: unk

Ibuprofen
    Dosage: unk

Celebrex
    Dosage: unk

Extra Strength Tylenol
    Dosage: unk

Tylenol (Caplet)
    Dosage: unk



Possible Naprosyn side effects in

Reported by a consumer/non-health professional from United States on 2012-05-07

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Benzylpenicillin Potassium
    Dosage: unk

Naproxen (Aleve)
    Dosage: unk

Nalbuphine Hydrochloride
    Dosage: unk

Cymbalta
    Dosage: unk

Erythromycin
    Dosage: unk

Demerol
    Dosage: unk

Codeine
    Dosage: unk

Reglan
    Dosage: unk

Tizanidine
    Dosage: unk

Naprosyn
    Dosage: unk

Oxycontin
    Dosage: unk



Possible Naprosyn side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-04

Patient: female

Reactions: Abdominal Pain, Anxiety, Nausea, Drug Hypersensitivity, Musculoskeletal Pain, Depression, Gastrooesophageal Reflux Disease, Muscle Spasms

Drug(s) suspected as cause:
Buspar
    Indication: Anxiety

Aldactone
    Dosage: 25 mg, 1x/day
    Administration route: Oral
    Indication: Blood Pressure Increased
    Start date: 2002-10-10
    End date: 2002-11-26

Nexium
    Dosage: 40 mg, 1x/day
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease
    Start date: 2002-11-26
    End date: 2003-01-30

Naprosyn
    Dosage: 500 mg, 2x/day
    Administration route: Oral
    Indication: Musculoskeletal Pain
    Start date: 1997-06-29
    End date: 1997-07-11

Buspar
    Dosage: 15 mg, 1x/day
    Administration route: Oral
    Indication: Affective Disorder
    Start date: 1997-10-29
    End date: 2000-12-07

Zocor
    Dosage: 20 mg, 1x/day
    Administration route: Oral
    Indication: Hyperlipidaemia
    Start date: 2008-06-05
    End date: 2008-08-25



Possible Naprosyn side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-02

Patient: male

Reactions: Lactose Intolerance, Urine Analysis Abnormal, Renal Disorder, Glomerular Filtration Rate Decreased, Blood Creatinine Increased

Drug(s) suspected as cause:
Lyrica
    Dosage: unk
    Indication: Back Disorder
    Start date: 2008-01-01

Naprosyn
    Dosage: unk



Possible Naprosyn side effects in male

Reported by a pharmacist from Ireland on 2012-05-02

Patient: male

Reactions: Visual Acuity Reduced, Vision Blurred, Photopsia

Drug(s) suspected as cause:
Naprosyn

Other drugs received by patient: Aspirin; Cardura; Istin; Lipitor; Losartan Potassium



Possible Naprosyn side effects in 63 year old female

Reported by a pharmacist from United States on 2012-05-01

Patient: 63 year old female, weighing 45.9 kg (101.0 pounds)

Reactions: Hiatus Hernia, Anaemia, Upper Gastrointestinal Haemorrhage, Gastritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naprosyn

Other drugs received by patient: Maxzide; Lisinopril



Possible Naprosyn side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-30

Patient: female, weighing 91.6 kg (201.5 pounds)

Reactions: Nausea, Pain, Abdominal Pain Upper

Drug(s) suspected as cause:
Oxycodone Hydrochloride
    Indication: Surgery

Naprosyn
    Dosage: unk

Oxycodone Hydrochloride
    Dosage: unk
    Indication: Cholelithiasis

Teriparatide
    Dosage: unk
    Indication: Osteoporosis

Other drugs received by patient: Atenolol; Celebrex; Protonix; Nexium; Synthroid



Possible Naprosyn side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-26

Patient: female

Reactions: Aphthous Stomatitis, Nonspecific Reaction, Pain, Gastric Disorder, Paraesthesia, Burning Sensation, Thought Blocking, Panic Attack, DRY Mouth, Mental Disorder, Spinal Disorder, Unevaluable Event, Therapy Regimen Changed, Neuritis

Drug(s) suspected as cause:
Celebrex
    Indication: Pain

Opiate Derivative
    Indication: Pain

Nitrofurantoin
    Indication: Infection

Naproxen (Aleve)
    Indication: Pain

Naprosyn
    Indication: Pain

Gabapentin
    Indication: Pain

Lyrica
    Administration route: Oral
    Indication: Pain

Hydrocodone
    Indication: Pain

Voltaren
    Indication: Pain

Motrin
    Indication: Pain

Other drugs received by patient: Valium



Possible Naprosyn side effects in male

Reported by a pharmacist from Ireland on 2012-04-24

Patient: male

Reactions: Visual Acuity Reduced, Vision Blurred, Photopsia

Drug(s) suspected as cause:
Naprosyn

Other drugs received by patient: Lipitor; Cardura; Istin; Aspirin; Losartan



Possible Naprosyn side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-18

Patient: female

Reactions: Aphthous Stomatitis, Pain, Adverse Drug Reaction, Gastric Disorder, Paraesthesia, Mental Impairment, Panic Attack, DRY Mouth, Spinal Disorder, Inflammation

Drug(s) suspected as cause:
Celebrex
    Dosage: 100 mg, bid
    Indication: Pain
    Start date: 2011-01-01

Aleve (Caplet)
    Indication: Pain

Motrin
    Indication: Pain

Voltaren
    Indication: Pain

Nitrofurantoin
    Indication: Infection

Naprosyn
    Indication: Pain

Lyrica
    Indication: Pain

Opiat
    Indication: Pain

Hydrocodone Bitartrate
    Indication: Pain

Other drugs received by patient: Valium; Valium



Possible Naprosyn side effects in female

Reported by a consumer/non-health professional from United States on 2012-04-13

Patient: female

Reactions: Malaise, Gastrointestinal Ulcer Haemorrhage, Band Sensation, Injection Site Scar, Injection Site Induration, Vascular Stenosis, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Naprosyn
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01

Rebif
    Indication: Multiple Sclerosis
    Start date: 2011-04-04

Coumadin
    Indication: Product Used FOR Unknown Indication



Possible Naprosyn side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: female, weighing 57.0 kg (125.4 pounds)

Reactions: Aphthous Stomatitis, Nausea, Drug Ineffective, Pain, Gastric Disorder, Paraesthesia, Anxiety, Burning Sensation, Mental Impairment, Panic Attack, Hypokinesia, Insomnia, DRY Mouth, Dizziness, Neuritis, Spinal Cord Disorder

Drug(s) suspected as cause:
Lyrica
    Indication: Pain

Lyrica
    Dosage: 25 mg, daily
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2012-02-26

Gabapentin
    Dosage: unk
    Indication: Pain

Nitrofurantoin
    Dosage: unk
    Indication: Infection

Naproxen (Aleve)
    Dosage: unk
    Indication: Pain

Celebrex
    Dosage: 100 mg, 2x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-01-01

Hydrocodone Bitartrate
    Dosage: unk
    Indication: Pain

Motrin
    Dosage: unk
    Indication: Pain

Naprosyn
    Dosage: unk
    Indication: Pain

Voltaren
    Dosage: unk
    Indication: Pain

Other drugs received by patient: Valium; Melatonin



Possible Naprosyn side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-26

Patient: female, weighing 57.0 kg (125.4 pounds)

Reactions: Wrong Technique in Drug Usage Process, Nonspecific Reaction, Drug Ineffective, Pain, Hypokinesia, DRY Mouth, Dizziness, Nervousness, Aphthous Stomatitis, Nausea, Incorrect Dose Administered, Condition Aggravated, Gastric Disorder, Paraesthesia, Anxiety, Mental Impairment, Burning Sensation, Panic Attack, Insomnia, Neuritis, Mobility Decreased, Spinal Cord Disorder

Drug(s) suspected as cause:
Gabapentin
    Dosage: unk
    Indication: Pain

Hydrocodone
    Dosage: unk
    Indication: Pain

Lyrica
    Dosage: 25 mg, daily
    Administration route: Oral
    Indication: Neuropathy Peripheral
    Start date: 2012-02-26

Naprosyn
    Dosage: unk
    Indication: Pain

Lyrica
    Indication: Pain

Motrin
    Dosage: unk
    Indication: Pain

Naproxen (Aleve)
    Dosage: unk
    Indication: Pain

Voltaren
    Dosage: unk
    Indication: Pain

Celebrex
    Dosage: 100 mg, 2x/day
    Administration route: Oral
    Indication: Pain
    Start date: 2011-01-01

Nitrofurantoin
    Dosage: unk
    Indication: Infection

Other drugs received by patient: Valium; Melatonin

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