About this FactMed analysis covering adverse side effect reports of NAPROSYN patients who developed ACANTHOLYSIS.

FactMed provides MD-approved analysis to help both patients, researchers, and physicians accurately assess the risk profile for more than 20,000 different pharmaceutical products. The below report offers compiled information from Food & Drug Administration and FactMed user submissions. Between January 2004 and October 2012, 7 individuals taking NAPROSYN reported ACANTHOLYSIS to the FDA. A total of 4604 NAPROSYN drug adverse event reaction reports were made with the FDA during this time period. Often the FDA only receives reports of the most critical and severe cases; these numbers may therefore underrepresent the complication rate of the medication.

FDA Research Report

Introduction This page is designed to help you determine the relationship, if any, between NAPROSYN and ACANTHOLYSIS. In doing so, we compare NAPROSYN with other drugs that cause ACANTHOLYSIS, to help you evaluate whether or not NAPROSYN causes ACANTHOLYSIS. Likewise, this page shows the most highly-reported side effects of NAPROSYN, so you can see if ACANTHOLYSIS ranks among NAPROSYN's most well-known side effects.
Summary Statistics
Reports of NAPROSYN causing ACANTHOLYSIS: 7
Reports of any side effect of NAPROSYN : 4604
Percentage of NAPROSYN patients where ACANTHOLYSIS is a reported side effect: 0.1520%

FDA reports of any drug causing ACANTHOLYSIS : 33
Average percentage for all medicated patients where ACANTHOLYSIS is reported as a complication: 0.0002%

Physician opinion on NAPROSYN as adverse event culprit:

Overall opinion for all reports of this drug:
Most frequent diagnoses/indications for prescribing NAPROSYN:
DRUG USE FOR UNKNOWN INDICATION ( 306 patients )
PAIN ( 235 patients )
PRODUCT USED FOR UNKNOWN INDICATION ( 177 patients )
ARTHRITIS ( 125 patients )
RHEUMATOID ARTHRITIS ( 116 patients )
ARTHRALGIA ( 70 patients )
BACK PAIN ( 66 patients )
OSTEOARTHRITIS ( 50 patients )
HEADACHE ( 22 patients )
INFLAMMATION ( 20 patients )
MIGRAINE ( 17 patients )
SCIATICA ( 16 patients )
PAIN IN EXTREMITY ( 16 patients )
ANKYLOSING SPONDYLITIS ( 15 patients )
JUVENILE ARTHRITIS ( 14 patients )
FIBROMYALGIA ( 14 patients )
ILL-DEFINED DISORDER ( 14 patients )
PREMEDICATION ( 12 patients )
MUSCULOSKELETAL DISCOMFORT ( 12 patients )
GOUT ( 11 patients )
DYSMENORRHOEA ( 10 patients )
SPONDYLITIS ( 8 patients )
PSORIATIC ARTHROPATHY ( 8 patients )
MUSCULOSKELETAL PAIN ( 7 patients )
PYREXIA ( 7 patients )
NECK PAIN ( 7 patients )
ANALGESIC THERAPY ( 7 patients )
DYSFUNCTIONAL UTERINE BLEEDING ( 5 patients )
NECK INJURY ( 5 patients )
PERICARDITIS ( 5 patients )
LIMB INJURY ( 5 patients )
ARTHROPATHY ( 5 patients )
ANTIINFLAMMATORY THERAPY ( 4 patients )
MUSCLE SPASMS ( 4 patients )
TENDON DISORDER ( 4 patients )
ROTATOR CUFF SYNDROME ( 4 patients )
MUSCLE STRAIN ( 4 patients )
PLANTAR FASCIITIS ( 4 patients )
TENDONITIS ( 3 patients )
NON-CARDIAC CHEST PAIN ( 3 patients )
CYST ( 3 patients )
SWELLING ( 3 patients )
BONE PAIN ( 3 patients )
PROCEDURAL PAIN ( 3 patients )
SPINAL OSTEOARTHRITIS ( 3 patients )
INTERVERTEBRAL DISC DISORDER ( 2 patients )
JOINT INJURY ( 2 patients )
ADVERSE DRUG REACTION ( 2 patients )
COSTOCHONDRITIS ( 2 patients )
MENSTRUAL CYCLE MANAGEMENT ( 2 patients )
TUMOUR PAIN ( 2 patients )
DISCOMFORT ( 2 patients )
SPINAL DISORDER ( 2 patients )
BACK DISORDER ( 2 patients )
MYALGIA ( 2 patients )
ENDODONTIC PROCEDURE ( 2 patients )
ABDOMINAL PAIN ( 2 patients )
NEUROPATHY PERIPHERAL ( 2 patients )
THROMBOPHLEBITIS ( 2 patients )
TOOTHACHE ( 2 patients )
CROHN'S DISEASE ( 2 patients )
MENSTRUAL DISCOMFORT ( 2 patients )
DACTYLITIS ( 2 patients )
SUICIDE ATTEMPT ( 1 patients )
BLOOD PRESSURE MANAGEMENT ( 1 patients )
EAR PAIN ( 1 patients )
SYSTEMIC LUPUS ERYTHEMATOSUS ( 1 patients )
BREAST PAIN ( 1 patients )
EPICONDYLITIS ( 1 patients )
NEURALGIA ( 1 patients )
CARDIAC DISORDER ( 1 patients )
PROPHYLAXIS AGAINST GASTROINTESTINAL ULCER ( 1 patients )
THROMBOSIS PROPHYLAXIS ( 1 patients )
CELLULITIS ( 1 patients )
KNEE OPERATION ( 1 patients )
OSTEOPOROSIS ( 1 patients )
TOOTH ABSCESS ( 1 patients )
HIV INFECTION ( 1 patients )
HYPERTENSIVE HEART DISEASE ( 1 patients )
PAIN MANAGEMENT ( 1 patients )
BLOOD CHOLESTEROL ( 1 patients )
INTENTIONAL OVERDOSE ( 1 patients )
POLYARTHRITIS ( 1 patients )
JOINT EFFUSION ( 1 patients )
BURSITIS ( 1 patients )
JOINT SPRAIN ( 1 patients )
PROPHYLAXIS ( 1 patients )
ERECTILE DYSFUNCTION ( 1 patients )
CAROTID ARTERY STENOSIS ( 1 patients )
KNEE ARTHROPLASTY ( 1 patients )
GENITAL PAIN FEMALE ( 1 patients )
TONSILLITIS ( 1 patients )
CHEST PAIN ( 1 patients )
RASH ( 1 patients )
ANTICOAGULANT THERAPY ( 1 patients )
OTITIS MEDIA ( 1 patients )
HORMONE LEVEL ABNORMAL ( 1 patients )
UPPER RESPIRATORY TRACT INFECTION ( 1 patients )
MUSCLE RELAXANT THERAPY ( 1 patients )
SENSORY DISTURBANCE ( 1 patients )
PARAESTHESIA ( 1 patients )
DRUG EXPOSURE DURING PREGNANCY ( 1 patients )
INFLAMMATORY PAIN ( 1 patients )
( 0 patients )
Drugs with high FDA adverse event association with ACANTHOLYSIS:

AMBIEN (10 patients)
ABRAXANE (9 patients)
ACIPHEX (9 patients)
AMPICILLIN (9 patients)
ASPIRIN (9 patients)
ATIVAN (9 patients)
AVASTIN (9 patients)
CYMBALTA (9 patients)
LEVOTHYROXINE SODIUM (9 patients)
NORCO (9 patients)
RADIATION (9 patients)
VICODIN (9 patients)
XELODA (9 patients)
ZOLOFT (9 patients)
ZOMETA (9 patients)
ZOFRAN (8 patients)
ARANESP (7 patients)
CAPECITABINE (7 patients)
CEFTRIAXONE (7 patients)
CEPHALEXIN (7 patients)
CIPROFLOXACIN (7 patients)
COLACE (7 patients)
DILAUDID (7 patients)
DOXIL (7 patients)
FEMARA (7 patients)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN (7 patients)
KEFLEX (7 patients)
LASIX (7 patients)
LORAZEPAM (7 patients)
NAPROSYN (7 patients)
NEULASTA (7 patients)
NIACIN (7 patients)
PERCOCET (7 patients)
PROVIGIL (7 patients)
RITALIN (7 patients)
SYNTHROID (7 patients)
TAXOTERE (7 patients)
VANCOMYCIN (7 patients)
VANCOMYCIN HCL (7 patients)
DEXAMETHASONE (6 patients)
FENTANYL (6 patients)
CYCLOSPORINE (4 patients)
PLAVIX (4 patients)
RELAFEN (4 patients)
ACETYLSALICYLIC ACID SRT (3 patients)
ACYCLOVIR (3 patients)
AMITIZA (3 patients)
NABUMETONE (3 patients)
NEXIUM (3 patients)
NIFEDIPINE (3 patients)
XIFAXAN (3 patients)
ALDACTAZIDE (2 patients)
AMLOR (2 patients)
AZATHIOPRINE (2 patients)
CLINDAMYCIN (2 patients)
COZAAR (2 patients)
DEPAKENE (2 patients)
DEPAS (2 patients)
DIGOXIN (2 patients)
DIPYRIDAMOL (2 patients)
EMPYNASE (2 patients)
ENALAPRIL MALEATE (2 patients)
ETRETINATE (2 patients)
FRACTAL (2 patients)
FUCIDIN CREAM (2 patients)
FUROSEMIDE (2 patients)
GAMUNEX (2 patients)
GLUCOR (2 patients)
HALCION (2 patients)
ISOSORBIDE MONONITRATE (2 patients)
LAMICTAL (2 patients)
LAXOBERON (2 patients)
LEVEMIR (2 patients)
MAGLAX (2 patients)
METHYLPREDNISOLONE (2 patients)
MINOCYCLIN (2 patients)
MOPRAL (2 patients)
MORPHINE (2 patients)
NITROGLYCERIN (2 patients)
PREDNISOLONE (2 patients)
PREDNISONE (2 patients)
SECTRAL (2 patients)
STILNOX (2 patients)
THEOPHYLLINE (2 patients)
TOPICAL ANTISEPTICS (2 patients)
ACENOCOUMAROL (1 patients)
ACENOCOUMAROL (ACENOCOUMAROL) (1 patients)
ACTIFED (1 patients)
AMILORIDE (1 patients)
AMILORIDE (AMILORIDE HYDROCHLORIDE) (1 patients)
ARNESP (1 patients)
ATENOLOL (1 patients)
ATORVASTATIN CALCIUM (1 patients)
BEMYLID (1 patients)
BETAMETHASONE DIPROPIIONATE (1 patients)
BETAMETHASONE DIPROPIONATE (1 patients)
CARBAMAZEPINE (1 patients)
CEFIXIME (1 patients)
CILAZAPRIL (1 patients)
CIPROFLOXACIN HCL (1 patients)
CIPROFLOXACIN IV (1 patients)
CISPLATIN (1 patients)
COPEGUS (1 patients)
DEXAMETHASONE ACETATE (1 patients)
DOXIUM (CALCIUM DOBESILATE) (1 patients)
ETHYOL (1 patients)
ETOPOSIDE (1 patients)
FENTANYL-100 (1 patients)
FILGRASTIM (FILGRASTIM) (1 patients)
FINASTERIDE (1 patients)
GEMZAR (1 patients)
GLIBENCLAMIDE (1 patients)
GLIMEPIRIDE (1 patients)
HEMERAN GEL (HEPARINOID) (1 patients)
HUMAN INSULIN (1 patients)
INSULIN ACTRAPID HUMAN (1 patients)
INTRON A (1 patients)
IRINOTECAN HCL (1 patients)
L-THYROXIN (1 patients)
LACIDIPINE (1 patients)
LACIDIPINE (LACIDIPINE) (1 patients)
MAGNESIUM OXIDE (MAGNESIUM OXIDE) (1 patients)
METHOTREXATE (1 patients)
MS CONTIN (1 patients)
OXYCODONE HCL (1 patients)
PEG-INTRON (1 patients)
PHENYTOIN (1 patients)
PRAVASTATIN (1 patients)
PRAVASTATIN SODIUM (1 patients)
PREDNISONE TAB (1 patients)
RADIATION THERAPY (1 patients)
REBETOL (1 patients)
RIBAVIRIN (1 patients)
TAREG (1 patients)
TOPICAL MEDICATIONS (FOR PSORIASIS) (1 patients)
ZETIA (1 patients)
Most common side effects for patients taking NAPROSYN:
PAIN (651 patients)
NAUSEA (476 patients)
ANXIETY (470 patients)
DYSPNOEA (465 patients)
DEPRESSION (392 patients)
BACK PAIN (386 patients)
ARTHRALGIA (369 patients)
FATIGUE (360 patients)
HEADACHE (359 patients)
DIZZINESS (332 patients)
VOMITING (312 patients)
PAIN IN EXTREMITY (310 patients)
OEDEMA PERIPHERAL (305 patients)
ASTHENIA (282 patients)
CHEST PAIN (282 patients)
WEIGHT DECREASED (282 patients)
DIARRHOEA (281 patients)
FALL (278 patients)
HYPERTENSION (265 patients)
ANAEMIA (262 patients)
INJURY (241 patients)
HYPOAESTHESIA (235 patients)
PYREXIA (227 patients)
OSTEONECROSIS OF JAW (220 patients)
MYOCARDIAL INFARCTION (220 patients)
PULMONARY EMBOLISM (215 patients)
DRUG INEFFECTIVE (209 patients)
PNEUMONIA (206 patients)
OSTEOARTHRITIS (203 patients)
COUGH (200 patients)
CONSTIPATION (199 patients)
INSOMNIA (197 patients)
ABDOMINAL PAIN (191 patients)
DEEP VEIN THROMBOSIS (190 patients)
DIABETES MELLITUS (189 patients)
EMOTIONAL DISTRESS (184 patients)
URINARY TRACT INFECTION (183 patients)
HYPOTENSION (173 patients)
BONE DISORDER (165 patients)
RASH (164 patients)
DECREASED APPETITE (163 patients)
DYSPEPSIA (163 patients)
CELLULITIS (162 patients)
PARAESTHESIA (161 patients)
BRONCHITIS (160 patients)
GASTROOESOPHAGEAL REFLUX DISEASE (160 patients)
VISION BLURRED (159 patients)
CHOLELITHIASIS (156 patients)
NEUROPATHY PERIPHERAL (154 patients)
OSTEOMYELITIS (154 patients)
DEHYDRATION (154 patients)
MALAISE (153 patients)
CEREBROVASCULAR ACCIDENT (153 patients)
DYSPHAGIA (147 patients)
MYALGIA (147 patients)
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (147 patients)
MUSCLE SPASMS (147 patients)
ABDOMINAL PAIN UPPER (146 patients)
WEIGHT INCREASED (143 patients)
GENERAL PHYSICAL HEALTH DETERIORATION (142 patients)
CARDIAC FAILURE CONGESTIVE (141 patients)
OSTEONECROSIS (137 patients)
IMPAIRED HEALING (137 patients)
CONFUSIONAL STATE (135 patients)
TOOTH EXTRACTION (134 patients)
MUSCULOSKELETAL PAIN (133 patients)
GAIT DISTURBANCE (132 patients)
MITRAL VALVE INCOMPETENCE (130 patients)
DEATH (129 patients)
PAIN IN JAW (124 patients)
ANHEDONIA (122 patients)
CONVULSION (119 patients)
GASTROINTESTINAL HAEMORRHAGE (118 patients)
NECK PAIN (118 patients)
HERPES ZOSTER (117 patients)
RENAL FAILURE ACUTE (117 patients)
PALPITATIONS (116 patients)
SEPSIS (111 patients)
SPINAL OSTEOARTHRITIS (110 patients)
CONTUSION (108 patients)
PLEURAL EFFUSION (108 patients)
PANCYTOPENIA (108 patients)
SYNCOPE (107 patients)
TREMOR (107 patients)
PRURITUS (106 patients)
MEMORY IMPAIRMENT (106 patients)
BLOOD GLUCOSE INCREASED (106 patients)
INTERVERTEBRAL DISC DEGENERATION (106 patients)
ARTHRITIS (106 patients)
RENAL FAILURE (105 patients)
ATELECTASIS (105 patients)
SWELLING (103 patients)
INTERVERTEBRAL DISC PROTRUSION (103 patients)
CHEST DISCOMFORT (102 patients)
CORONARY ARTERY DISEASE (102 patients)
ATRIAL FIBRILLATION (101 patients)
MUSCULAR WEAKNESS (101 patients)
UPPER RESPIRATORY TRACT INFECTION (101 patients)
SINUSITIS (100 patients)
BONE PAIN (99 patients)
SOMNOLENCE (98 patients)
DECREASED INTEREST (98 patients)
DIVERTICULUM (96 patients)
ERYTHEMA (96 patients)
FEELING ABNORMAL (96 patients)
CHOLECYSTITIS CHRONIC (95 patients)
ABSCESS (93 patients)
CARDIOMEGALY (92 patients)
HYPERHIDROSIS (91 patients)
HAEMATURIA (90 patients)
INFECTION (89 patients)
GASTRITIS (88 patients)
HYPOKALAEMIA (86 patients)
HYPERLIPIDAEMIA (86 patients)
CONDITION AGGRAVATED (85 patients)
INJECTION SITE PAIN (83 patients)
HYPERGLYCAEMIA (83 patients)
HAEMOGLOBIN DECREASED (83 patients)
CHILLS (82 patients)
COLONIC POLYP (82 patients)
HALLUCINATION (81 patients)
BURSITIS (81 patients)
SWELLING FACE (81 patients)
DRY MOUTH (81 patients)
ROAD TRAFFIC ACCIDENT (79 patients)
GASTRIC ULCER (79 patients)
RESPIRATORY FAILURE (79 patients)
BLOOD CHOLESTEROL INCREASED (79 patients)
OEDEMA (79 patients)
PANCREATITIS (78 patients)
RENAL FAILURE CHRONIC (78 patients)
RECTAL HAEMORRHAGE (78 patients)
HAEMORRHOIDS (78 patients)
POLLAKIURIA (78 patients)
NEPHROLITHIASIS (78 patients)
URTICARIA (78 patients)
ASTHMA (77 patients)
LOSS OF CONSCIOUSNESS (77 patients)
VERTIGO (77 patients)
PULMONARY OEDEMA (77 patients)
HIATUS HERNIA (77 patients)
BLOOD PRESSURE INCREASED (76 patients)
CATARACT (74 patients)
JOINT SWELLING (74 patients)
LUNG INFILTRATION (73 patients)
TRICUSPID VALVE INCOMPETENCE (73 patients)
RIB FRACTURE (73 patients)
TOOTH DISORDER (73 patients)
ARTERIOSCLEROSIS (73 patients)
HAEMATOCHEZIA (72 patients)
TYPE 2 DIABETES MELLITUS (71 patients)
DRUG WITHDRAWAL SYNDROME (70 patients)
OSTEOPOROSIS (70 patients)
SLEEP APNOEA SYNDROME (70 patients)
LETHARGY (69 patients)
TOOTH FRACTURE (68 patients)
OROPHARYNGEAL PAIN (68 patients)
RESPIRATORY DISTRESS (68 patients)
THROMBOCYTOPENIA (68 patients)
SUICIDAL IDEATION (68 patients)
EPISTAXIS (68 patients)
DENTAL CARIES (66 patients)
ARRHYTHMIA (66 patients)
TACHYCARDIA (65 patients)
ABDOMINAL DISCOMFORT (64 patients)
TOOTH INFECTION (64 patients)
RENAL CYST (64 patients)
BALANCE DISORDER (64 patients)
HYPERCHOLESTEROLAEMIA (64 patients)
DRUG DEPENDENCE (63 patients)
HYPOXIA (63 patients)
MENISCUS LESION (63 patients)
ACUTE MYOCARDIAL INFARCTION (62 patients)
CARDIAC DISORDER (62 patients)
METASTASES TO BONE (62 patients)
SLEEP DISORDER (61 patients)
CARPAL TUNNEL SYNDROME (61 patients)
NEOPLASM MALIGNANT (60 patients)
SCOLIOSIS (60 patients)
TOOTHACHE (59 patients)
GALLBLADDER DISORDER (59 patients)
ABDOMINAL DISTENSION (58 patients)
DEFORMITY (58 patients)
FLUSHING (58 patients)
FISTULA (58 patients)
LIVER FUNCTION TEST ABNORMAL (58 patients)
CHOLECYSTITIS (58 patients)
HAEMORRHAGE (57 patients)
URINARY INCONTINENCE (56 patients)
SINUS TACHYCARDIA (56 patients)
PRIMARY SEQUESTRUM (56 patients)
TOOTH LOSS (56 patients)
ERECTILE DYSFUNCTION (56 patients)
STOMATITIS (56 patients)
MENTAL STATUS CHANGES (55 patients)
OVERDOSE (55 patients)
MUSCULOSKELETAL STIFFNESS (55 patients)
ROTATOR CUFF SYNDROME (55 patients)
RENAL DISORDER (55 patients)
MUSCULOSKELETAL CHEST PAIN (55 patients)
FOOT FRACTURE (54 patients)
LUMBAR SPINAL STENOSIS (54 patients)
DIVERTICULUM INTESTINAL (54 patients)
DRUG INTERACTION (54 patients)
HEPATIC STEATOSIS (54 patients)
ARTHROPATHY (54 patients)
SCAR (53 patients)
FEAR (53 patients)
BONE LESION (53 patients)
HOT FLUSH (52 patients)

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Recent FactMed Activity for NAPROSYN


Issue Description / Topic Timestamp
QUESTION
MYASTHENIA GRAVIS
Can a patient w myasthenia gravis take naprosyn 2015-03-08 19:24:51
QUESTION
DERMATITIS
I have had for many years a high level of Monoclonal Antibodies unrelated to cancer. During the years I noticed if I took Alieve for any reason that ailed me, I had lot more energy that day and was less sleepy. While searching for more information on Monoclonal Antibodies I found a study where Naprosyn reduced the Monoclonal Antibodies. This prompted me to try Naprosyn. I started taking Naproxina available in Acapulco, Mexico, where I was vacationing in March 2016. I took only 250 Mg daily and I felt great. I had plenty of energy, was very active and started to shed some of the excess weight. I lost noticeable amount of fat from my body ("Loss of fat contributing to dermatitis?"). After 4 weeks of Naproxina I started itching in the neck, back and upper arms. I returned to US in the middle of April and continued Naprosyn in the form of Alieve 220 Mg daily. The itching increased in severity and in extent. Started getting small reddish pimples causing throbbing pain and severe itching. These lesions became larger in size, varying from 1 to 4 mm. Most of them either flat or a mm in size. Some areas show no skin eruption but a lot of pain and itching. Scratching makes everything worse. So I am doing my best not to scratch. Thinking, Naprosyn may be the cause I have stopped Naprosyn three weeks ago without any change in the skin lesions nor the painful itch? As treatment, I took Medral Dose pack, tried Benedryl tabs, Benadryl cream and calamine lotion. These have not helped. The Clobestasol Propionate 0.05 % gives me 4 hours relief from many of the lesions, but not all. The pain and itching from some areas is relentless. The only way I am dealing with this is continuously doing something until I am exhausted and then fall asleep for a while. I have been bit by mosquitos in Acapulco. I don't think this is Zika. It could be some other virus. 2016-06-01 17:47:00

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