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Arthrotec Side Effects

PatientsVille

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#9447453
Gastric Disorder
This is a report of a 54-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: tendon disorder, who was treated with Arthrotec (dosage: 0.2 Mg/ 75 Mg, Once A Day, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Gastric Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in female patients, resulting in Gastric Disorder side effect.
Arthrotec Side Effect Report#9447443
Cataract
This report suggests a potential Arthrotec Cataract side effect(s) that can have serious consequences. A 83-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteoarthritis,hypertension and used Arthrotec (dosage: Unk, 2x/day) starting NS. After starting Arthrotec the patient began experiencing various side effects, including: CataractAdditional drugs used concurrently:
  • Amlodipine/olmesartan Medoxomil (Unk)
Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cataract, may still occur.
Arthrotec Side Effect Report#9443640
Hallucination, Vision Blurred
This Hallucination problem was reported by a consumer or non-health professional from US. A 57-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoarthritis,hypersensitivity. On 2012 this consumer started treatment with Arthrotec (dosage: 75 Mg/200, 2x/day). The following drugs were being taken at the same time:
  • Benadryl (Unk)
  • Lortab (Unk)
  • Flonase (Unk)
When using Arthrotec, the patient experienced the following unwanted symptoms/side effects: Hallucination, Vision BlurredAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hallucination, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#9379901
Bundle Branch Block Left, Left Ventricular Dysfunction
This Bundle Branch Block Left side effect was reported by a physician from GB. A 83-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoarthritis,hypertension,blood cholesterol increased.The patient was prescribed Arthrotec (drug dosage: 75 Mg, Unk), which was initiated on 200310. Concurrently used drugs:
  • Lercanidipine (Unk)
  • Simvastatin (20 Mg, 1x/day)
.After starting to take Arthrotec the consumer reported adverse symptoms, such as: Bundle Branch Block Left, Left Ventricular DysfunctionThese side effects may potentially be related to Arthrotec. The patient was hospitalized.
Arthrotec Side Effect Report#9378848
Sciatica, Headache
This is a report of a 54-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: psoriatic arthropathy,neuropathy peripheral, who was treated with Arthrotec (dosage: Unk, 1x/day, start time: NS), combined with:
  • Neurontin (Unk)
  • Hydrocodone W/acetaminophen
and developed a serious reaction and side effect(s): Sciatica, Headache after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in female patients, resulting in Sciatica side effect.
Arthrotec Side Effect Report#9372818
Blood Pressure Increased, Skin Reaction, Urticaria, Rash Papular, Off Label Use
This report suggests a potential Arthrotec Blood Pressure Increased side effect(s) that can have serious consequences. A 54-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: dermatitis,hypertension and used Arthrotec (dosage: Unk, Once A Day) starting 201306. After starting Arthrotec the patient began experiencing various side effects, including: Blood Pressure Increased, Skin Reaction, Urticaria, Rash Papular, Off Label UseAdditional drugs used concurrently:
  • Lisinopril (Unk)
  • Aspirin (Unk, Once A Day)
  • Prevacid (Unk)
  • Hydrocortisone (Unk)
  • Clonazepam (2 Mg, Unk)
Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Pressure Increased, may still occur.
Arthrotec Side Effect Report#9337128
Arthropathy, Arthralgia
This Arthropathy problem was reported by a consumer or non-health professional from US. A 71-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: arthritis. On NS this consumer started treatment with Arthrotec (dosage: 75 Mg, 2x/day). The following drugs were being taken at the same time:
  • Omeprazole (Unk)
  • Diltiazem (240 Mg, Unk)
  • Synthroid (150 Ug, Unk)
  • Lexapro (20 Mg, Unk)
  • Wellbutrin Sr (150 Mg, Unk)
When using Arthrotec, the patient experienced the following unwanted symptoms/side effects: Arthropathy, ArthralgiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arthropathy, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#9337127
Upper Limb Fracture, Arthropathy, Neuropathy Peripheral
This Upper Limb Fracture side effect was reported by a consumer or non-health professional from US. A 75-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Arthrotec (drug dosage: 75 Mg, 2x/day), which was initiated on NS. Concurrently used drugs:
  • Omeprazole (Unk)
  • Diltiazem (240 Mg, Unk)
  • Synthroid (150 Ug, Unk)
  • Lexapro (20 Mg, Unk)
  • Wellbutrin Sr (150 Mg, Unk)
.After starting to take Arthrotec the consumer reported adverse symptoms, such as: Upper Limb Fracture, Arthropathy, Neuropathy PeripheralThese side effects may potentially be related to Arthrotec.
Arthrotec Side Effect Report#9337053
Myelopathy, Lumbar Spinal Stenosis, Spinal Osteoarthritis
This is a report of a 66-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis, who was treated with Arthrotec (dosage: 75 Mg, Two Times A Day, start time: NS), combined with:
  • Omeprazole (Unk)
  • Diltiazem (240 Mg, Unk)
  • Synthroid (150 Ug, Unk)
  • Lexapro (20 Mg, Unk)
  • Wellbutrin Sr (150 Mg, Unk)
and developed a serious reaction and side effect(s): Myelopathy, Lumbar Spinal Stenosis, Spinal Osteoarthritis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in female patients, resulting in Myelopathy side effect.
Arthrotec Side Effect Report#9320982
Fall, Joint Injury
This report suggests a potential Arthrotec Fall side effect(s) that can have serious consequences. A 72-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pain and used Arthrotec (dosage: 50/200 Mg/mcg, 2x/day) starting NS. After starting Arthrotec the patient began experiencing various side effects, including: Fall, Joint InjuryAdditional drugs used concurrently: NA. Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Fall, may still occur.
Arthrotec Side Effect Report#9314598
Myasthenia Gravis, Libido Decreased, Hearing Impaired, Abdominal Discomfort, Diarrhoea, Alopecia
This Myasthenia Gravis problem was reported by a consumer or non-health professional from US. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoarthritis. On NS this consumer started treatment with Arthrotec (dosage: 75 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: Myasthenia Gravis, Libido Decreased, Hearing Impaired, Abdominal Discomfort, Diarrhoea, AlopeciaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myasthenia Gravis, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#9311280
Arthropathy, Hypertension, Pain, Weight Abnormal
This Arthropathy side effect was reported by a consumer or non-health professional from US. A 76-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Arthrotec (drug dosage: 0.2/50 Mg, 1x/day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Arthrotec the consumer reported adverse symptoms, such as: Arthropathy, Hypertension, Pain, Weight AbnormalThese side effects may potentially be related to Arthrotec.
Arthrotec Side Effect Report#9305967
Diverticulitis
This is a report of a 74-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: osteoarthritis, who was treated with Arthrotec (dosage: 75 Mg, 2x/day, start time:
Feb 11, 2010), combined with: NA. and developed a serious reaction and side effect(s): Diverticulitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in male patients, resulting in Diverticulitis side effect.
Arthrotec Side Effect Report#9263608
Chronic Obstructive Pulmonary Disease
This report suggests a potential Arthrotec Chronic Obstructive Pulmonary Disease side effect(s) that can have serious consequences. A 41-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthritis,osteoarthritis,neuropathy peripheral,tachycardia,blood cholesterol abnormal and used Arthrotec (dosage: Unk , 2x/day) starting NS. After starting Arthrotec the patient began experiencing various side effects, including: Chronic Obstructive Pulmonary DiseaseAdditional drugs used concurrently: NA. Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Chronic Obstructive Pulmonary Disease, may still occur.
Arthrotec Side Effect Report#9260184
Hearing Impaired, Epigastric Discomfort
This Hearing Impaired problem was reported by a consumer or non-health professional from US. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoarthritis. On
Apr 22, 2013 this consumer started treatment with Arthrotec (dosage: 1 Df, 2x/day). The following drugs were being taken at the same time:
  • Diclofenac Epolamine (Unk)
When using Arthrotec, the patient experienced the following unwanted symptoms/side effects: Hearing Impaired, Epigastric DiscomfortAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hearing Impaired, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#9245637
Abdominal Discomfort
This Abdominal Discomfort side effect was reported by a consumer or non-health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: arthritis.The patient was prescribed Arthrotec (drug dosage: 75 Mg, 1x/day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Arthrotec the consumer reported adverse symptoms, such as: Abdominal DiscomfortThese side effects may potentially be related to Arthrotec.
Arthrotec Side Effect Report#9239553
Hypertension
This is a report of a 51-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis,convulsion, who was treated with Arthrotec (dosage: 1 Df, 1x/day, start time: 2000), combined with:
  • Lyrica (200 Mg, Daily)
and developed a serious reaction and side effect(s): Hypertension after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in male patients, resulting in Hypertension side effect.
Arthrotec Side Effect Report#9216881
Arthropathy
This report suggests a potential Arthrotec Arthropathy side effect(s) that can have serious consequences. A 81-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthritis,hypertension and used Arthrotec (dosage: 75/0.2 Mg, 2x/day) starting NS. After starting Arthrotec the patient began experiencing various side effects, including: ArthropathyAdditional drugs used concurrently:
  • Diovan (valsartan) (80 Mg, 2x/day)
  • Metoprolol (50 Mg, 2x/day)
The patient was hospitalized. Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Arthropathy, may still occur.
Arthrotec Side Effect Report#9204211
Osteoarthritis, Diverticulitis, Diverticulum Intestinal Haemorrhagic, Gastric Haemorrhage
This Osteoarthritis problem was reported by a consumer or non-health professional from US. A 85-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoarthritis. On NS this consumer started treatment with Arthrotec (dosage: [diclofenac 75]/ [misoprostol 200 Mcg], 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: Osteoarthritis, Diverticulitis, Diverticulum Intestinal Haemorrhagic, Gastric HaemorrhageThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Osteoarthritis, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#9169638
Abdominal Pain Upper, Enzyme Level Increased
This Abdominal Pain Upper side effect was reported by a consumer or non-health professional from DK. A 57-year-old female patient (weight:NA) experienced the following symptoms/conditions: arthralgia.The patient was prescribed Arthrotec (drug dosage: 1 Df, 1x/day (200mcg+50mg)), which was initiated on
Feb 14, 2013. Concurrently used drugs:
  • Omeprazol
  • Lercanidipine Hydrochloride
.After starting to take Arthrotec the consumer reported adverse symptoms, such as: Abdominal Pain Upper, Enzyme Level IncreasedThese side effects may potentially be related to Arthrotec. The patient was hospitalized.
Arthrotec Side Effect Report#9168338
Ankle Fracture, Off Label Use
This is a report of a 76-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis,neuropathy peripheral,hypoaesthesia,blood pressure abnormal, who was treated with Arthrotec (dosage: 200/75 Mg, 2x/day, start time: NS), combined with:
  • Simvastatin (Unk)
  • Simvastatin
  • Hydrochlorothiazide (Unk)
and developed a serious reaction and side effect(s): Ankle Fracture, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in female patients, resulting in Ankle Fracture side effect.
Arthrotec Side Effect Report#9160959
Hepatic Enzyme Increased
This report suggests a potential Arthrotec Hepatic Enzyme Increased side effect(s) that can have serious consequences. A female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arthritis and used Arthrotec (dosage: Unk) starting NS. After starting Arthrotec the patient began experiencing various side effects, including: Hepatic Enzyme IncreasedAdditional drugs used concurrently:
  • Excedrin (Unk)
  • Meloxicam (Unk)
  • Aleve (Unk)
Although Arthrotec demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hepatic Enzyme Increased, may still occur.
Arthrotec Side Effect Report#9149224
Bronchitis, Upper Respiratory Tract Infection, Arthralgia, Malaise, Pain, Insomnia
This Bronchitis problem was reported by a consumer or non-health professional from US. A 62-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: arthritis. On 201302 this consumer started treatment with Arthrotec (dosage: Unk, 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: Bronchitis, Upper Respiratory Tract Infection, Arthralgia, Malaise, Pain, InsomniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Bronchitis, may become evident only after a product is in use by the general population.
Arthrotec Side Effect Report#9146227
Cardiac Discomfort, Spinal Cord Compression, Cerebrospinal Fluid Leakage, Meningitis, Hypertension, Blood Cholesterol Increased, Body Height Decreased
This Cardiac Discomfort side effect was reported by a health professional from US. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoarthritis.The patient was prescribed Arthrotec (drug dosage: 75/200 Mg/mcg, 2x/day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Arthrotec the consumer reported adverse symptoms, such as: Cardiac Discomfort, Spinal Cord Compression, Cerebrospinal Fluid Leakage, Meningitis, Hypertension, Blood Cholesterol Increased, Body Height DecreasedThese side effects may potentially be related to Arthrotec. The patient was hospitalized.
Arthrotec Side Effect Report#9135816
Gastrointestinal Haemorrhage
This is a report of a 70-year-old female patient (weight: NA) from CA, suffering from the following health symptoms/conditions: NA, who was treated with Arthrotec (dosage: 50 Mg, Unk, start time:
Sep 04, 2011), combined with:
  • Pantoloc (40 Mg, 2x/day)
and developed a serious reaction and side effect(s): Gastrointestinal Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Arthrotec treatment in female patients, resulting in Gastrointestinal Haemorrhage side effect. The patient was hospitalized.


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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.

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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    How Effective is Arthrotec for You?

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    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