PatientsVille.com Logo

PatientsVille

Arthrotec Side Effects

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.

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.

Arthrotec Side Effects Reported to FDA

The following 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.


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.
Nasopharyngitis, Paranasal Sinus Hypersecretion
This is a report of a 78-year-old female patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Nasopharyngitis
  • Paranasal Sinus Hypersecretion
which developed 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.

Malaise, Nausea
This report suggests a potential Arthrotec Malaise, Nausea 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. Soon after starting Arthrotec the patient began experiencing various side effects, including:
  • Malaise
  • Nausea
Drugs used concurrently: NA. Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as malaise, may still occur.

Malaise, Nausea
This Malaise, Nausea 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 commencing Arthrotec, the patient experienced the following unwanted symptoms/side effects:
  • Malaise
  • Nausea
Although 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.

Gastrooesophageal Reflux Disease
This is a report of a 64-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: arthritis and was treated with Arthrotec (dosage: 1 Df, 75/0.2 Mg, 2x/day) starting 1973. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Gastrooesophageal Reflux Disease
This opens a possibility that Arthrotec treatment could cause the above reactions, including gastrooesophageal reflux disease, and some female subjects may be more susceptible.


Arthropathy, Rotator Cuff Syndrome, Psoriasis
A 61-year-old female patient (weight: NA) from US with the following symptoms/conditions: psoriatic arthropathy started Arthrotec treatment (dosage: 75 Mg/ 200 Mcg, 2x/day) on NS. Soon after starting Arthrotec treatment, the subject experienced various side effects, including:
  • Arthropathy
  • Rotator Cuff Syndrome
  • Psoriasis
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Arthrotec.

Hypoaesthesia, Paralysis, Dizziness, Diarrhoea, Amnesia, Ear Pain, Chills, Asthenia, Visual Impairment
A 72-year-old female patient from NO (weight: NA) experienced symptoms, such as: osteoarthritis and was treated with Arthrotec(dosage: 1 Df, 1x/day). The treatment was initiated on Feb 01, 2013. After that a consumer reported the following side effect(s):
  • Hypoaesthesia
  • Paralysis
  • Dizziness
  • Diarrhoea
  • Amnesia
  • Ear Pain
  • Chills
  • Asthenia
  • Visual Impairment
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Arthrotec efficacy: NA.The patient was hospitalized.

Muscle Rupture, Fibromyalgia, Muscle Disorder
In this report, Arthrotec was administered for the following condition: psoriatic arthropathy,fibromyalgia.A 66-year-old female consumer from US (weight: NA) started Arthrotec treatment (dosage: 200mcg/75mg, 2x/day) on 2007.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Muscle Rupture
  • Fibromyalgia
  • Muscle Disorder
A possible interaction with other drugs could have contributed to this reaction:
  • Lyrica (25 Mg, 1x/day)
  • Enbrel (25 Mg, 2x/week)
  • Calcium (Unk)
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Arthrotec treatment could be related to the listed above side effect(s).

Myocardial Infarction
This is a report of the following Arthrotec side effect(s):
  • Myocardial Infarction
A 54-year-old male patient from US (weight: NA) presented with the following condition: disability,spinal osteoarthritis,blood cholesterol abnormal and received a treatment with Arthrotec (dosage: Unk,(50/0.2mg), 2x/day) starting: 2004.The following concurrently used drugs could have generated interactions: NA.The patient was hospitalized.This report suggests that a Arthrotec treatment could be associated with the listed above side effect(s).

Erectile Dysfunction
This Arthrotec report was submitted by a 45-year-old male consumer from US (weight: NA). The patient was diagnosed with: arthritis and Arthrotec was administered (dosage: 200 Mcg/75 Mg) starting: NS. The consumer developed a set of symptoms:
  • Erectile Dysfunction
Other drugs used simultaneously: NA.Those unexpected symptoms could be linked to a Arthrotec treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Urinary Tract Infection, Flushing, Erythema, Tinnitus
This is a report of a possible correlation between Arthrotec use and the following symptoms/side effect(s):
  • Urinary Tract Infection
  • Flushing
  • Erythema
  • Tinnitus
which could contribute to an assessment of Arthrotec risk profile.A 53-year-old female consumer from US (weight: NA) was suffering from tendinitis,thyroid activity decreased and was treated with Arthrotec (dosage: 1 Df(200 Mcg+75mg), 2x/day) starting Dec 17, 2012.Other concurrent medications:
  • Synthroid (Unk)


Transient Ischaemic Attack
A female patient from US (weight: NA) presented with the following symptoms: blood pressure increased,tia and after a treatment with Arthrotec (dosage: 1 Daily 2 Weeks) experienced the following side effect(s):
  • Transient Ischaemic Attack
The treatment was started on NS. Arthrotec was used in combination with the following drugs: NA.This report could alert potential Arthrotec consumers.

Urinary Tract Infection, Tooth Infection, Tooth Abscess, Weight Decreased, Tooth Fracture, Dental Caries
In this report, a 70-year-old female patient from US (weight: NA) was affected by a possible Arthrotec side effect.The patient was diagnosed with arthritis. After a treatment with Arthrotec (dosage: 200 Ug/75 Mg, 2x/day, start date: 201107), the patient experienced the following side effect(s):
  • Urinary Tract Infection
  • Tooth Infection
  • Tooth Abscess
  • Weight Decreased
  • Tooth Fracture
  • Dental Caries
The following simultaneously used drugs could have led to this reaction:
  • Tylenol (Unk, 2x/day)
  • Morphine (Unk)
  • Evista (Unk)
  • Depakote (Unk)
  • Celexa (Unk)
The findings here stress that side effects should be taken into consideration when evaluating a Arthrotec treatment.

Fall, Respiratory Arrest, Feeling Abnormal
This is a report of a 58-year-old male patient from US (weight: NA), who used Arthrotec (dosage: Aug. On - Aug-26) for a treatment of arthritis. After starting a treatment on NS, the patient experienced the following side effect(s):
  • Fall
  • Respiratory Arrest
  • Feeling Abnormal
The following drugs could possibly have interacted with the Arthrotec treatment NA.Taken together, these observations suggest that a Arthrotec treatment could be related to side effect(s), such as Fall, Respiratory Arrest, Feeling Abnormal.

Abdominal Pain Upper, Gastrointestinal Pain, Dizziness, Nausea, Diarrhoea, Faecal Incontinence
This abdominal pain upper side effect was reported by a consumer or non-health professional from US. A 68-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis lupus erythematosis. The patient was prescribed Arthrotec (dosage: Ec 75 Mg - 200 Mcg 1 Tab Twice Daily Mouth), which was started on Oct 30, 2012. Concurrently used drugs: NA. When starting to take Arthrotec the consumer reported the following symptoms:
  • Abdominal Pain Upper
  • Gastrointestinal Pain
  • Dizziness
  • Nausea
  • Diarrhoea
  • Faecal Incontinence
These side effects may potentially be related to Arthrotec.

No Adverse Event
This is a Arthrotec side effect report of a 46-year-old male patient (weight:NA) from US, suffering from the following symptoms/conditions: NA, who was treated with Arthrotec (dosage:NA, start time: NS), combined with: NA., and developed a serious reaction and a no adverse event side effect. The patient presented with:
  • No Adverse Event
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Arthrotec treatment in male patients suffering from NA, resulting in no adverse event.

Eye Swelling, Dyspnoea, Pain, Nausea
This report suggests a potential Arthrotec eye swelling side effect(s) that can have serious consequences. A 89-year-old female patient from US (weight:NA) was diagnosed with the following health condition(s): arthralgia,blood pressure abnormal,cardiac disorder,hypertension and used Arthrotec (dosage: 200ug/50mg, 2x/day) starting 201111. Soon after starting Arthrotec the patient began experiencing various side effects, including:
  • Eye Swelling
  • Dyspnoea
  • Pain
  • Nausea
Drugs used concurrently:
  • Enalapril (5 Mg, Daily)
  • Enalapril (Unk)
  • Enalapril
  • Atenolol (25 Mg, 1x/day)
  • Caduet (1 Df, 1x/day)
  • Caduet
  • Coumadin (Unk)
  • Simvastatin (Unk)
Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as eye swelling, may still occur.

Back Disorder, Pain
This back disorder problem was reported by a consumer or non-health professional from US. A 57-year-old female patient (weight: NA) was diagnosed with the following medical condition(s): arthritis,nerve injury,restless legs syndrome.On 201103 a consumer started treatment with Arthrotec (dosage: 75/200 Mg/mcg , 2x/day). The following drugs/medications were being taken at the same time:
  • Lyrica (150 Mg, 2x/day)
  • Lyrica
  • Lyrica
  • Astelin (Unk)
  • Flonase (Unk)
  • Bumex (Unk)
  • Zantac (Unk)
  • Omeprazole (Unk)
When commencing Arthrotec, the patient experienced the following unwanted symptoms /side effects:
  • Back Disorder
  • Pain
Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as back disorder, may become evident only after a product is in use by the general population.

Back Disorder, Pain, Thoracic Vertebral Fracture, Intervertebral Disc Disorder
This is a Arthrotec side effect report of a female patient (weight: NA) from US. The patient developed the following symptoms/conditions: arthritis,nerve injury,restless legs syndrome and was treated with Arthrotec (dosage: 75/200 Mg/mcg, 2x/day) starting 201104. Concurrently used drugs:
  • Lyrica (150 Mg, 2x/day)
  • Lyrica (150 Mg, 2x/day)
  • Lyrica
  • Lyrica
  • Astelin (Unk)
  • Flonase (Unk)
  • Bumex (Unk)
  • Zantac (Unk)
Soon after that, the consumer experienced the following of symptoms:
  • Back Disorder
  • Pain
  • Thoracic Vertebral Fracture
  • Intervertebral Disc Disorder
The patient was hospitalized. This opens a possibility that Arthrotec could cause back disorder and that some female patients may be more susceptible.

Abdominal Pain Upper, Chest Pain
A 72-year-old female patient (weight: NA) from US with the following symptoms: arthritis started Arthrotec treatment (dosage: 75/200 Mg/mcg, 2x/day) on 201211. Soon after starting Arthrotec treatment, the consumer experienced several side effects, including:
  • Abdominal Pain Upper
  • Chest Pain
. Concurrently used drugs:
  • Diclofenac (75/200 Mg/mcg, 2x/day)
  • Furosemide (Unk)
This finding indicates that some patients can be more vulnerable to developing Arthrotec side effects, such as abdominal pain upper.

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 (dosage: Unk), which was started on NS. Concurrently used drugs: NA..When starting to take Arthrotec the consumer reported symptoms, such as:
  • Abasia
  • Knee Arthroplasty
These side effects may potentially be related to Arthrotec.

No Adverse Event
This is a report of a 60-year-old male patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • No Adverse Event
which developed 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.

Coeliac Disease, Malaise, Diarrhoea, Rectal Discharge, Nausea
This report suggests a potential Arthrotec Coeliac Disease, Malaise, Diarrhoea, Rectal Discharge, Nausea 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. Soon after starting Arthrotec the patient began experiencing various side effects, including:
  • Coeliac Disease
  • Malaise
  • Diarrhoea
  • Rectal Discharge
  • Nausea
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.

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 commencing Arthrotec, the patient experienced the following unwanted symptoms/side effects:
  • Pain
Although 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.

Joint Stiffness
This is a report of a 56-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: arthritis and was treated with Arthrotec (dosage: Unk) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Joint Stiffness
This opens a possibility that Arthrotec treatment could cause the above reactions, including joint stiffness, and some female subjects may be more susceptible.

Nasopharyngitis
A 49-year-old female patient (weight: NA) from US with the following symptoms/conditions: rheumatoid arthritis started Arthrotec treatment (dosage: 75mg/200mcg , 1x/day) on NS. Soon after starting Arthrotec treatment, the subject experienced various side effects, including:
  • Nasopharyngitis
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Arthrotec.

  3 of 21 



Top 10 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

Top 10 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

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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

    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.


    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
    Somewhat Effective
    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