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Arthrotec Side Effects

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Common Arthrotec Side Effects


The most commonly reported Arthrotec side effects (click to view or check a box to report):

Diarrhoea (47)
Abdominal Pain Upper (39)
Nausea (36)
Pain (27)
Malaise (25)
Arthralgia (18)
Fall (18)
Chest Pain (18)
Abdominal Pain (17)
Abdominal Discomfort (17)
Arthropathy (16)
Dyspnoea (16)
Dyspepsia (15)
Pruritus (14)
Chills (13)
Urticaria (13)
Headache (13)
Renal Failure (12)
Rash (12)
Oedema Peripheral (11)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Arthrotec Side Effects Reported to FDA



Arthrotec Side Effect Report#9133642
Nasopharyngitis, Paranasal Sinus Hypersecretion
This is a report of a 78-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthralgia,urinary incontinence, who was treated with Arthrotec (dosage: Unk, 2x/day, start time: NS), combined with:
  • Toviaz (4 Mg, 1x/day)
  • Micardis (80 Mg, Unk)
and developed a serious reaction and side effect(s): Nasopharyngitis, Paranasal Sinus Hypersecretion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in female patients, resulting in Nasopharyngitis side effect.
Arthrotec Side Effect Report#9105834
Malaise, Nausea
This report suggests a potential Arthrotec Malaise side effect(s) that can have serious consequences. A 70-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteoarthritis,rheumatoid arthritis,blood cholesterol increased and used Arthrotec (dosage: 50 Mg, 2x/day) starting 201302. After starting Arthrotec the patient began experiencing various side effects, including: Malaise, NauseaAdditional drugs used concurrently: NA. Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Malaise, may still occur.
Arthrotec Side Effect Report#9105833
Malaise, Nausea
This Malaise problem was reported by a consumer or non-health professional from US. A 70-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoarthritis,rheumatoid arthritis,blood cholesterol increased. On 201302 this consumer started treatment with Arthrotec (dosage: 50 Mg, 2x/day). The following drugs were being taken at the same time: NA. When using Arthrotec, the patient experienced the following unwanted symptoms/side effects: Malaise, NauseaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Malaise, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#9098649
Gastrooesophageal Reflux Disease
This Gastrooesophageal Reflux Disease side effect was reported by a consumer or non-health professional from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Arthrotec (drug dosage: 1 Df, 75/0.2 Mg, 2x/day), which was initiated on 1973. Concurrently used drugs: NA..After starting to take Arthrotec the consumer reported adverse symptoms, such as: Gastrooesophageal Reflux DiseaseThese side effects may potentially be related to Arthrotec.
Arthrotec Side Effect Report#9097364
Arthropathy, Arthropathy, Rotator Cuff Syndrome, Psoriasis
This is a report of a 61-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: psoriatic arthropathy, who was treated with Arthrotec (dosage: 75 Mg/ 200 Mcg, 2x/day, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Arthropathy, Arthropathy, Rotator Cuff Syndrome, Psoriasis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in female patients, resulting in Arthropathy side effect.
Arthrotec Side Effect Report#9054759
Hypoaesthesia, Paralysis, Dizziness, Diarrhoea, Amnesia, Ear Pain, Chills, Asthenia, Visual Impairment
This report suggests a potential Arthrotec Hypoaesthesia side effect(s) that can have serious consequences. A 72-year-old female patient (weight: NA) from NO was diagnosed with the following symptoms/conditions: osteoarthritis and used Arthrotec (dosage: 1 Df, 1x/day) starting
Feb 01, 2013. After starting Arthrotec the patient began experiencing various side effects, including: Hypoaesthesia, Paralysis, Dizziness, Diarrhoea, Amnesia, Ear Pain, Chills, Asthenia, Visual ImpairmentAdditional drugs used concurrently: NA.The patient was hospitalized. Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypoaesthesia, may still occur.
Arthrotec Side Effect Report#9054116
Muscle Rupture, Fibromyalgia, Muscle Disorder
This Muscle Rupture problem was reported by a consumer or non-health professional from US. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: psoriatic arthropathy,fibromyalgia. On 2007 this consumer started treatment with Arthrotec (dosage: 200mcg/75mg, 2x/day). The following drugs were being taken at the same time:
  • Lyrica (25 Mg, 1x/day)
  • Enbrel (25 Mg, 2x/week)
  • Calcium (Unk)
When using Arthrotec, the patient experienced the following unwanted symptoms/side effects: Muscle Rupture, Fibromyalgia, Muscle DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Muscle Rupture, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#9031307
Myocardial Infarction, Myocardial Infarction
This Myocardial Infarction side effect was reported by a consumer or non-health professional from US. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: disability,spinal osteoarthritis,blood cholesterol abnormal.The patient was prescribed Arthrotec (drug dosage: Unk,(50/0.2mg), 2x/day), which was initiated on 2004. Concurrently used drugs: NA..After starting to take Arthrotec the consumer reported adverse symptoms, such as: Myocardial Infarction, Myocardial InfarctionThese side effects may potentially be related to Arthrotec. The patient was hospitalized.
Arthrotec Side Effect Report#9018543
Erectile Dysfunction
This is a report of a 45-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis, who was treated with Arthrotec (dosage: 200 Mcg/75 Mg, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Erectile Dysfunction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in male patients, resulting in Erectile Dysfunction side effect.
Arthrotec Side Effect Report#8984886
Urinary Tract Infection, Flushing, Erythema, Tinnitus
This report suggests a potential Arthrotec Urinary Tract Infection side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: tendinitis,thyroid activity decreased and used Arthrotec (dosage: 1 Df(200 Mcg+75mg), 2x/day) starting
Dec 17, 2012. After starting Arthrotec the patient began experiencing various side effects, including: Urinary Tract Infection, Flushing, Erythema, TinnitusAdditional drugs used concurrently:
  • Synthroid (Unk)
Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Urinary Tract Infection, may still occur.
Arthrotec Side Effect Report#8978348
Transient Ischaemic Attack
This Transient Ischaemic Attack problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: blood pressure increased,tia. On NS this consumer started treatment with Arthrotec (dosage: 1 Daily 2 Weeks). The following drugs were being taken at the same time: NA. When using Arthrotec, the patient experienced the following unwanted symptoms/side effects: Transient Ischaemic AttackAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Transient Ischaemic Attack, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#8966927
Urinary Tract Infection, Tooth Infection, Tooth Abscess, Weight Decreased, Tooth Fracture, Dental Caries
This Urinary Tract Infection side effect was reported by a consumer or non-health professional from US. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Arthrotec (drug dosage: 200 Ug/75 Mg, 2x/day), which was initiated on 201107. Concurrently used drugs:
  • Tylenol (Unk, 2x/day)
  • Morphine (Unk)
  • Evista (Unk)
  • Depakote (Unk)
  • Celexa (Unk)
.After starting to take Arthrotec the consumer reported adverse symptoms, such as: Urinary Tract Infection, Tooth Infection, Tooth Abscess, Weight Decreased, Tooth Fracture, Dental CariesThese side effects may potentially be related to Arthrotec.
Arthrotec Side Effect Report#8962350
Fall, Respiratory Arrest, Feeling Abnormal
This is a report of a 58-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis, who was treated with Arthrotec (dosage: Aug. On - Aug-26, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Fall, Respiratory Arrest, Feeling Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in male patients, resulting in Fall side effect.
Arthrotec Side Effect Report#8962338
Abdominal Pain Upper, Gastrointestinal Pain, Dizziness, Nausea, Diarrhoea, Faecal Incontinence
This report suggests a potential Arthrotec Abdominal Pain Upper side effect(s) that can have serious consequences. A 68-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthritis lupus erythematosis and used Arthrotec (dosage: Ec 75 Mg - 200 Mcg 1 Tab Twice Daily Mouth) starting
Oct 30, 2012. After starting Arthrotec the patient began experiencing various side effects, including: Abdominal Pain Upper, Gastrointestinal Pain, Dizziness, Nausea, Diarrhoea, Faecal IncontinenceAdditional drugs used concurrently: NA. Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abdominal Pain Upper, may still occur.
Arthrotec Side Effect Report#8962328
No Adverse Event
This No Adverse Event problem was reported by a health professional from US. A 46-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Arthrotec (dosage: NA). The following drugs were being taken at the same time: NA. When using Arthrotec, the patient experienced the following unwanted symptoms/side effects: No Adverse EventAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as No Adverse Event, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#8960741
Eye Swelling, Dyspnoea, Pain, Nausea
This Eye Swelling side effect was reported by a physician from US. A 89-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthralgia,blood pressure abnormal,cardiac disorder,hypertension.The patient was prescribed Arthrotec (drug dosage: 200ug/50mg, 2x/day), which was initiated on 201111. Concurrently used drugs:
  • Enalapril (5 Mg, Daily)
  • Enalapril (Unk)
  • Enalapril
  • Atenolol (25 Mg, 1x/day)
  • Caduet (1 Df, 1x/day)
  • Caduet
  • Coumadin (Unk)
  • Simvastatin (Unk)
.After starting to take Arthrotec the consumer reported adverse symptoms, such as: Eye Swelling, Dyspnoea, Pain, NauseaThese side effects may potentially be related to Arthrotec.
Arthrotec Side Effect Report#8949892
Back Disorder, Pain
This is a report of a 57-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis,nerve injury,restless legs syndrome, who was treated with Arthrotec (dosage: 75/200 Mg/mcg , 2x/day, start time: 201103), combined with:
  • Lyrica (150 Mg, 2x/day)
  • Lyrica
  • Lyrica
  • Astelin (Unk)
  • Flonase (Unk)
  • Bumex (Unk)
  • Zantac (Unk)
  • Omeprazole (Unk)
and developed a serious reaction and side effect(s): Back Disorder, Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in female patients, resulting in Back Disorder side effect.
Arthrotec Side Effect Report#8949892
Back Disorder, Pain, Thoracic Vertebral Fracture, Intervertebral Disc Disorder
This report suggests a potential Arthrotec Back Disorder side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthritis,nerve injury,restless legs syndrome and used Arthrotec (dosage: 75/200 Mg/mcg, 2x/day) starting 201104. After starting Arthrotec the patient began experiencing various side effects, including: Back Disorder, Pain, Thoracic Vertebral Fracture, Intervertebral Disc DisorderAdditional drugs used concurrently:
  • Lyrica (150 Mg, 2x/day)
  • Lyrica (150 Mg, 2x/day)
  • Lyrica
  • Lyrica
  • Astelin (Unk)
  • Flonase (Unk)
  • Bumex (Unk)
  • Zantac (Unk)
The patient was hospitalized. Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Back Disorder, may still occur.
Arthrotec Side Effect Report#8948175
Abdominal Pain Upper, Chest Pain
This Abdominal Pain Upper problem was reported by a consumer or non-health professional from US. A 72-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: arthritis. On 201211 this consumer started treatment with Arthrotec (dosage: 75/200 Mg/mcg, 2x/day). The following drugs were being taken at the same time:
  • Diclofenac (75/200 Mg/mcg, 2x/day)
  • Furosemide (Unk)
When using Arthrotec, the patient experienced the following unwanted symptoms/side effects: Abdominal Pain Upper, Chest PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Pain Upper, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#8943848
Abasia, Knee Arthroplasty
This Abasia side effect was reported by a consumer or non-health professional from US. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Arthrotec (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Arthrotec the consumer reported adverse symptoms, such as: Abasia, Knee ArthroplastyThese side effects may potentially be related to Arthrotec.
Arthrotec Side Effect Report#8923884
No Adverse Event
This is a report of a 60-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Arthrotec (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): No Adverse Event after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in male patients, resulting in No Adverse Event side effect.
Arthrotec Side Effect Report#8922626
Coeliac Disease, Malaise, Diarrhoea, Rectal Discharge, Nausea
This report suggests a potential Arthrotec Coeliac Disease side effect(s) that can have serious consequences. A 61-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: knee arthritis,joint disorder,glaucoma and used Arthrotec (dosage: 200ug/75mg , 2x/day) starting 201210. After starting Arthrotec the patient began experiencing various side effects, including: Coeliac Disease, Malaise, Diarrhoea, Rectal Discharge, NauseaAdditional drugs used concurrently: NA. Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Coeliac Disease, may still occur.
Arthrotec Side Effect Report#8905960
Pain
This Pain problem was reported by a consumer or non-health professional from US. A 49-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: arthritis. On
Nov 01, 2012 this consumer started treatment with Arthrotec (dosage: 75/200mg Two Times A Day). The following drugs were being taken at the same time: NA. When using Arthrotec, the patient experienced the following unwanted symptoms/side effects: PainAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pain, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#8903619
Joint Stiffness
This Joint Stiffness side effect was reported by a health professional from US. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Arthrotec (drug dosage: Unk), which was initiated on NS. Concurrently used drugs: NA..After starting to take Arthrotec the consumer reported adverse symptoms, such as: Joint StiffnessThese side effects may potentially be related to Arthrotec.
Arthrotec Side Effect Report#8885742
Nasopharyngitis
This is a report of a 49-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: rheumatoid arthritis, who was treated with Arthrotec (dosage: 75mg/200mcg , 1x/day, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Nasopharyngitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in female patients, resulting in Nasopharyngitis side effect.


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The appearance of Arthrotec on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

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What are common Arthrotec Side Effects for Women?

Women Side EffectsReports
Diarrhoea 39
Abdominal Pain Upper 37
Nausea 34
Pain 25
Malaise 19
Abdominal Pain 17
Arthropathy 15
Abdominal Discomfort 14
Arthralgia 13
Chest Pain 13

What are common Arthrotec Side Effects for Men?

Men Side EffectsReports
Vision Blurred 7
Diarrhoea 6
Malaise 6
Urticaria 6
Arthralgia 5
Chest Pain 5
Death 5
Rash 5
Renal Failure 5
Renal Failure Acute 5

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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 reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Discuss Arthrotec Side Effects

    Did You Have a Arthrotec Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Arthrotec for You?

    Exceeded Expectations
    Effective
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    Not Effective

    Arthrotec Safety Alerts, Active Ingredients, Usage Information

    NDC0025-1411
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameARTHROTEC
    Namediclofenac sodium and misoprostol
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since19971224
    LabelerG.D. Searle LLC Division of Pfizer Inc
    Active Ingredient(s)DICLOFENAC SODIUM; MISOPROSTOL
    Strength(s)50; 200
    Unit(s)mg/1; ug/1
    Pharma ClassCyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammato

    Arthrotec Dosage, Warnings, Usage.

    Side Effects reported to FDA: 525

    Arthrotec safety alerts: No

    Reported deaths: 29

    Reported hospitalizations: 165

    Latest Arthrotec clinical trials