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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