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Thyroid Function (5)
Blurring Eyes (2)
Chills (2)
Depression (2)
Itching (2)
Bloody Stools (1)
Hunger Pain (1)
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Arthrotec Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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  Showing 76-100 of 426 

Diarrhoea, Gastrointestinal Disorder, Flatulence (7729260-6)
on Sep 02, 2011 Female from UNITED STATES , weighting 165.0 lb, was diagnosed with
  • arthritis
  • blood pressure abnormal
and was treated with Arthrotec. Directly after, patient experienced the unwanted or unexpected Arthrotec side effects: diarrhoea, gastrointestinal disorder, flatulence. Arthrotec dosage: 75 Mg, 1x/day.
Associated medications used:
  • Lisinopril (10mg Two At A Time, Daily)
  • Ibuprofen (200 Mg, 3x/day)
  • Allopurinol (300 Mg, 1x/day)
  • Zolpidem Tartrate (10 Mg, As Needed)
  • Simvastatin (20 Mg, 1x/day)
  • Acetylsalicylic Acid (81 Mg, 1x/day)
  • Tylenol-500 (Unk)


Off Label Use, Coagulation Test Abnormal, Increased Tendency To Bruise (7710996-8)
Patient was taking Arthrotec. Patient felt the following Arthrotec side effects: off label use, coagulation test abnormal, increased tendency to bruise on Aug 16, 2011 from UNITED STATES Additional patient health information: Female , 38 years of age, weighting 179.0 lb, was diagnosed with
  • osteoarthritis
and. Arthrotec dosage: N/A.
Multiple prescriptions taken:
  • Naproxen
  • Vivelle
  • Nexium


Multiple Allergies, Oedema Peripheral, Fall, Amnesia, Gait Disturbance, Lower Limb Fracture, Scar, Rash, Psoriasis (7635999-3)
Adverse event was reported on Jul 12, 2011 by a Male taking Arthrotec (Dosage: 75 Mg, Tid) was diagnosed with
  • bone pain
  • sleep disorder
and. Location: UNITED STATES , 42 years of age, weighting 224.9 lb, After Arthrotec was administered, patient encountered several Arthrotec side effects: multiple allergies, oedema peripheral, fall, amnesia, gait disturbance, lower limb fracture, scar, rash, psoriasis.
Multiple concurrent drugs taken:
  • Trazodone Hcl (50 Mg, Hs)
  • Ibuprofen (Unk)
  • Protonix (Unk)
  • Aspirin (Unk)
  • Vicodin (5 / 500 Mg)
Patient was hospitalized and became disabled.

Bone Pain, Oedema Peripheral, Hepatic Function Abnormal, Lower Limb Fracture, Gait Disturbance, Somnambulism, Hypersensitivity, Fall (7633916-3)
on Jul 15, 2011 Male from UNITED STATES , 42 years of age, weighting 225.1 lb, was diagnosed with
  • bone pain
  • gastrooesophageal reflux disease
and was treated with Arthrotec. Directly after, patient experienced the unwanted or unexpected Arthrotec side effects: bone pain, oedema peripheral, hepatic function abnormal, lower limb fracture, gait disturbance, somnambulism, hypersensitivity, fall. Arthrotec dosage: N/A.
Associated medications used:
  • Protonix
  • Vicodin (5/500mg, 2x/day)
  • Ibuprofen
  • Aspirin
  • Trazodone Hcl (50 Mg Once Daily Before Bed)
Patient was hospitalized and became disabled.


Nausea (7620050-1)
on Jul 13, 2011 Female from UNITED STATES , weighting 110.0 lb, was diagnosed with
  • arthritis
and was treated with Arthrotec. Patient felt the following Arthrotec side effects: nausea. Arthrotec dosage: 75 Mg, 2x/day.
Multiple prescriptions taken:
  • Neurontin


Pain (7620029-X)
Patient was taking Arthrotec. After Arthrotec was administered, patient encountered several Arthrotec side effects: pain on Jul 15, 2011 from UNITED STATES Additional patient health information: Female , 42 years of age, . Arthrotec dosage: Unk.

Emotional Distress, Chest Pain (7605703-3)
Adverse event was reported on Jul 08, 2011 by a Female taking Arthrotec (Dosage: 1 Df,2x/day) was diagnosed with
  • arthralgia
  • pain
and. Location: IRELAND , 62 years of age, Directly after, patient experienced the unwanted or unexpected Arthrotec side effects: emotional distress, chest pain.
Associated medications used:
  • Paramol (Unk)


Pain In Extremity, Oedema Peripheral (7603867-9)
on Jul 08, 2011 Male from UNITED STATES , weighting 168.0 lb, was diagnosed with
  • oedema peripheral
and was treated with Arthrotec. Patient felt the following Arthrotec side effects: pain in extremity, oedema peripheral. Arthrotec dosage: Unk.

Oedema Peripheral (7577050-X)
on Jun 23, 2011 Female from UNITED STATES , 85 years of age, was diagnosed with
  • pain management
and was treated with Arthrotec. After Arthrotec was administered, patient encountered several Arthrotec side effects: oedema peripheral. Arthrotec dosage: 50/200 Mg, Unk.

Erythema, Flushing (7576925-5)
Patient was taking Arthrotec. Directly after, patient experienced the unwanted or unexpected Arthrotec side effects: erythema, flushing on Jun 24, 2011 from UNITED STATES Additional patient health information: Male , weighting 154.0 lb, was diagnosed with
  • arthritis
and. Arthrotec dosage: Unk.

Hallucination, Hyperhidrosis, Memory Impairment (7573228-X)
Adverse event was reported on Jun 21, 2011 by a Male taking Arthrotec (Dosage: 50 Mg, 4x/day) was diagnosed with
  • bursitis
and. Location: NETHERLANDS , 31 years of age, weighting 220.5 lb, Patient felt the following Arthrotec side effects: hallucination, hyperhidrosis, memory impairment.
Multiple prescriptions taken:
  • Codeine Phosphate And Acetaminophen (500 Mg, Unk)


Alopecia (7570244-9)
on Jun 22, 2011 Female from UNITED STATES , weighting 185.0 lb, was treated with Arthrotec. After Arthrotec was administered, patient encountered several Arthrotec side effects: alopecia. Arthrotec dosage: N/A.
Multiple concurrent drugs taken:
  • Lovastatin
  • Imatrix
  • Hydrocodone


Chills, Oxygen Saturation Abnormal, Chest Pain, Anaphylactic Shock, Paraesthesia, Hypotension, Renal Failure Acute (7564152-7)
on Jun 17, 2011 Male from FRANCE , 37 years of age, was diagnosed with
  • back pain
and was treated with Arthrotec. Directly after, patient experienced the unwanted or unexpected Arthrotec side effects: chills, oxygen saturation abnormal, chest pain, anaphylactic shock, paraesthesia, hypotension, renal failure acute. Arthrotec dosage: 1 Df, Single. Patient was hospitalized.

Renal Failure (7539439-4)
Patient was taking Arthrotec. Patient felt the following Arthrotec side effects: renal failure on Jun 08, 2011 from UNITED STATES Additional patient health information: Female , 51 years of age, . Arthrotec dosage: Unk.

Injury, Emotional Distress, Unevaluable Event, Anxiety, Renal Failure, Fear, Renal Failure Acute, Pain (7507161-6)
Adverse event was reported on Nov 09, 2010 by a Female taking Arthrotec (Dosage: 75/200 One Tablet) . Location: UNITED STATES , 66 years of age, weighting 187.4 lb, After Arthrotec was administered, patient encountered several Arthrotec side effects: injury, emotional distress, unevaluable event, anxiety, renal failure, fear, renal failure acute, pain.
Multiple concurrent drugs taken:
  • Nitroglycerin
  • Sodium Bicarbonate (150 Meq)
  • Red Blood Cells (2 U, Unk)
  • Lipitor (20 Mg At Night)
  • Heparin (30000 Units)
  • Trasylol (200 Cc)
  • Trasylol
  • Lotensin (10 Mg, Qd)
Patient was hospitalized.

Gastrointestinal Haemorrhage (7505471-X)
on May 23, 2011 Male from UNITED STATES , 45 years of age, weighting 185.0 lb, was treated with Arthrotec. Directly after, patient experienced the unwanted or unexpected Arthrotec side effects: gastrointestinal haemorrhage. Arthrotec dosage: 200ug/75mg, 2x/day.

Blood Magnesium Decreased, Fall, Blood Potassium Decreased, Oedema Peripheral (7497006-5)
on May 09, 2011 Female from CANADA , weighting 95.24 lb, was treated with Arthrotec. Patient felt the following Arthrotec side effects: blood magnesium decreased, fall, blood potassium decreased, oedema peripheral. Arthrotec dosage: N/A.
Multiple prescriptions taken:
  • Quinine Sulfate
  • Folic Acid
  • Triazide
  • Apo-nifed
  • Mtx
  • Potassium Chloride
  • Prevacid
  • Amitriptyline Hcl
Patient was hospitalized.

Injury, Unevaluable Event, Renal Failure, Pain, Renal Failure Acute (7490767-0)
Patient was taking Arthrotec. After Arthrotec was administered, patient encountered several Arthrotec side effects: injury, unevaluable event, renal failure, pain, renal failure acute on Oct 29, 2009 from UNITED STATES Additional patient health information: Male , 77 years of age, weighting 277.8 lb, . Arthrotec dosage: 75 Mg, Bid.
Multiple concurrent drugs taken:
  • Norvasc (10 Mg, Qd)
  • Versed (10 Mg, Iv Push)
  • Amidate (20 Mg,iv Push X2)
  • Lipitor (20 Mg, Qd)
  • Isosorbide Dinitrate (60 G, Qd)
  • Micardis Hct (80/12.5 Mg , Qd)
  • Avandamet (2/500 Mg, Bid)
  • Trasylol (1 Ml, Initial Test Dose)
Patient was hospitalized.

Rash Pruritic, Nausea, Urticaria, Rash Erythematous (7480822-3)
Adverse event was reported on May 12, 2011 by a Female taking Arthrotec (Dosage: 50mg -200 1 Tab By Mouth Twice A Day With Food As Needed 1 2x Day) was diagnosed with
  • arthritis
and. Location: UNITED STATES , 63 years of age, weighting 210.0 lb, Directly after, patient experienced the unwanted or unexpected Arthrotec side effects: rash pruritic, nausea, urticaria, rash erythematous.

Decreased Appetite, Fibrosis, Abdominal Discomfort, Diarrhoea, Mucosal Inflammation, Tenderness, Weight Decreased (7474077-3)
on Apr 28, 2011 Female from UNITED STATES , 80 years of age, was diagnosed with
  • arthritis
  • hypertension
and was treated with Arthrotec. Patient felt the following Arthrotec side effects: decreased appetite, fibrosis, abdominal discomfort, diarrhoea, mucosal inflammation, tenderness, weight decreased. Arthrotec dosage: 50 Mg, Bid.
Multiple prescriptions taken:
  • Atenolol (50 Mg, Unk)
  • Aspirin (75 Mg, Daily)
  • Pravastatin Sodium (20 Mg, Daily)
  • Amitriptyline Hcl (Unk)
  • Hydrocortisone
  • Levothyroxine Sodium (75 Mcg, Daily)
Patient was hospitalized.

Abdominal Pain Upper, Product Substitution Issue, Economic Problem (7465004-3)
on May 05, 2011 Female from UNITED STATES , weighting 150.4 lb, was diagnosed with
  • arthritis
and was treated with Arthrotec. After Arthrotec was administered, patient encountered several Arthrotec side effects: abdominal pain upper, product substitution issue, economic problem. Arthrotec dosage: 75mg/200mg 2x Over 30 Years.

Diarrhoea, Product Quality Issue, Muscle Spasms (7464568-3)
Patient was taking Arthrotec. Directly after, patient experienced the unwanted or unexpected Arthrotec side effects: diarrhoea, product quality issue, muscle spasms on May 03, 2011 from UNITED STATES Additional patient health information: Female , weighting 160.0 lb, . Arthrotec dosage: N/A.
Associated medications used:
  • Atenolol (Unk)


Headache, Blood Pressure Increased (7462306-1)
Adverse event was reported on Apr 19, 2011 by a Female taking Arthrotec (Dosage: 75 Mg, As Needed) was diagnosed with
  • arthritis
and. Location: NETHERLANDS , 67 years of age, Patient felt the following Arthrotec side effects: headache, blood pressure increased.
Multiple prescriptions taken:
  • Urso Falk (250 Mg, 1x/day)
  • Gabapentin (300 Mg, 1x/day)
  • Omeprazole (40 Mg, 1x/day)
  • Enbrel (50 Mg, Weekly)
  • Metoprolol Succinate (200 Mg, 1x/day)


Abdominal Pain, Back Pain, Muscular Weakness, Nausea, Pain In Extremity, Oedema Peripheral, Night Sweats, Neck Pain (7455386-0)
on Apr 28, 2011 Female from UNITED STATES , weighting 105.1 lb, was diagnosed with
  • rheumatoid arthritis
and was treated with Arthrotec. After Arthrotec was administered, patient encountered several Arthrotec side effects: abdominal pain, back pain, muscular weakness, nausea, pain in extremity, oedema peripheral, night sweats, neck pain. Arthrotec dosage: N/A.
Multiple concurrent drugs taken:
  • Humira
  • Multi-vitamins
  • Humira


Bronchitis, Diarrhoea, Upper Respiratory Tract Infection, Abdominal Discomfort (7450935-0)
on Apr 30, 2011 Female from UNITED STATES , weighting 134.5 lb, was diagnosed with
  • arthritis
and was treated with Arthrotec. Directly after, patient experienced the unwanted or unexpected Arthrotec side effects: bronchitis, diarrhoea, upper respiratory tract infection, abdominal discomfort. Arthrotec dosage: Unk.

  Showing 76-100 of 426 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Arthrotec Information

Alternative ARTHROTEC Names:DICLOFENA

Active Ingredient: DICLOFENA

Arthrotec Dosage, Warnings, Usage.

Side Effects reported to FDA: 426. View Arthrotec Adverse Reports

Arthrotec safety alerts: No

Reported deaths: 26

Reported hospitalizations: 138

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