This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Arthrotec (Diclofenac / Misoprostol) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (199)
Death (2)
Life Threatening Events (5)
Disability (5)
Reports by Reaction Type
Drug Ineffective (21),
Nausea (15),
Drug Hypersensitivity (14),
Pain (13),
Malaise (12),
Abdominal Pain Upper (11),
Diarrhoea (10),
Arthritis (10),
Cholestasis (9),
Fall (9),
Myocardial Infarction (8),
Anaemia (7)
Below are a few examples of reports where side effects / adverse reactions may be related to Arthrotec (Diclofenac / Misoprostol). For a complete list or a specific selection of reports, please use the links above.
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: female
Reactions: Muscle Strain, Pain, Gait Disturbance, Back Injury
Drug(s) suspected as cause:
Arthrotec
Dosage: unk
Feldene
Dosage: 10 mg, unk
Possible Arthrotec side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: male
Reactions: Pneumonia, Pneumothorax
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arthrotec
Possible Arthrotec side effects in 87 year old female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: 87 year old female, weighing 70.3 kg (154.6 pounds)
Reactions: Weight Increased, Epigastric Discomfort, Joint Swelling, Arthralgia, Oedema Peripheral, Hypertension, Arthritis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arthrotec
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: female
Reactions: Arthritis
Drug(s) suspected as cause:
Arthrotec
Norvasc
Zoloft
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Arthrotec
Possible Arthrotec side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 50 year old female, weighing 72.0 kg (158.4 pounds)
Reactions: Pruritus, Upper Limb Fracture, Nausea, Pain, Fall, Blood Glucose Increased
Drug(s) suspected as cause:
Armodafinil
Dosage: unk
Arthrotec
Dosage: unk
Glucotrol
Dosage: unk
Hydrocodone Bitartrate + Acetaminophen
Dosage: 7.5/750 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2012-04-24
End date: 2012-05-01
Neurontin
Dosage: 600 mg, 1x/day
Administration route: Oral
Neurontin
Dosage: 300 mg, 1x/day
Administration route: Oral
Indication: Neuropathy Peripheral
Percocet
Dosage: 10/325 mg, 3x/day
Administration route: Oral
Indication: Pain
Start date: 2012-04-21
End date: 2012-04-22
Possible Arthrotec side effects in 88 year old female
Reported by a consumer/non-health professional from United States on 2012-08-14
Patient: 88 year old female, weighing 68.0 kg (149.7 pounds)
Reactions: Weight Decreased, Malaise, Vomiting, Gastrointestinal Ulcer Haemorrhage, Nausea, Decreased Appetite, Abdominal Pain Upper
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arthrotec
Dosage: 200 mcg+75mg 2xday 5days in a week
Administration route: Oral
Indication: Arthritis
Start date: 2011-08-01
End date: 2012-04-06
Voltaren
Dosage: 1 df, 2x/day
Other drugs received by patient: Norco; Lidoderm; Microzide; CO-Q-10
Possible Arthrotec side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Ambien CR
Amoxicillin
Dosage: 0.5, qd
Arthrotec
Administration route: Oral
Biaxin
Cefzil
Lipitor
Administration route: Oral
Livalo
Lortab
Oxacillin Sodium
PCE
Pravachol
Provigil
Sulfamethoxazole
Ultram
Zetia
Administration route: Oral
Zocor
Administration route: Oral
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: female
Reactions: Arthropathy, Arthralgia, Dyspepsia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arthrotec
Dosage: 0.2/50 mg, 2x/day
Administration route: Oral
Indication: Arthritis
Arthrotec
Dosage: 0.2/50 mg, 1x/day
Administration route: Oral
End date: 2011-11-01
Celebrex
Dosage: 200 mg, 1x/day
Administration route: Oral
Start date: 2012-01-01
Celebrex
Dosage: 200 mg, 2x/day
Administration route: Oral
Indication: Arthritis
Start date: 2012-01-01
End date: 2012-01-01
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: female
Reactions: Malaise, Impaired Work Ability, Mental Disorder
Drug(s) suspected as cause:
Arthrotec
Possible Arthrotec side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-30
Patient: male
Reactions: Headache, Malignant Neoplasm of Eye, Local Swelling, Attention Deficit / Hyperactivity Disorder, Joint Injury, Arthritis, Cardiac Disorder
Drug(s) suspected as cause:
Arthrotec
Dosage: unk
Neurontin
Dosage: unk
Nitrostat
Dosage: unk
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: female, weighing 65.0 kg (143.0 pounds)
Reactions: Drug Ineffective
Drug(s) suspected as cause:
Arthrotec
Dosage: 75 mg, 2x/day
Administration route: Oral
Arthrotec
Dosage: 50 mg, 2x/day
Administration route: Oral
Indication: Arthritis
Other drugs received by patient: Wellbutrin; Atenolol
Possible Arthrotec side effects in 91 year old female
Reported by a pharmacist from United States on 2012-07-27
Patient: 91 year old female, weighing 58.5 kg (128.7 pounds)
Reactions: Anaemia, International Normalised Ratio Increased, Hypophagia, Thrombocytopenia, Melaena, Odynophagia, Renal Failure Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Amiodarone HCL
Dosage: 200 mg daily po chronic
Administration route: Oral
Indication: Atrial Fibrillation
Arthrotec
Dosage: 50-200mg daily po chronic
Administration route: Oral
Warfarin Sodium
Dosage: 2 mg / 3 mg eod alt po recently restarted
Administration route: Oral
Indication: Atrial Fibrillation
Other drugs received by patient: VIT C; Oxybutynin Chloride; Allegra; Hydrochlorothiazide; Furosemide; Prilosec; M.v.i.; Doxazosin Mesylate; Diazepam; Vit+d3
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: female
Reactions: Arthritis
Drug(s) suspected as cause:
Arthrotec
Dosage: unk
Indication: Arthritis
Celebrex
Dosage: unk
Administration route: Oral
Indication: Arthritis
Lyrica
Dosage: two capsules of 75mg in the evening and one capsule of 75mg with one capsule of 50mg in the morning
Administration route: Oral
Lyrica
Dosage: unk, 1x/day
Administration route: Oral
Possible Arthrotec side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-26
Patient:
Reactions: Breast Cancer
Drug(s) suspected as cause:
Arthrotec
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-26
Patient: female
Reactions: Urinary Incontinence
Drug(s) suspected as cause:
Arthrotec
Possible Arthrotec side effects in 82 year old female
Reported by a consumer/non-health professional from United Kingdom on 2012-07-25
Patient: 82 year old female
Reactions: Drug Interaction, Aura, Vaginal Haemorrhage, Metrorrhagia
Drug(s) suspected as cause:
Arthrotec
Other drugs received by patient possibly interacting with the suspect drug:
Premarin
Dosage: 0.625 mg, 1x/day, 3 weeks out of four
Indication: Hormone Replacement Therapy
Start date: 1985-01-01
Other drugs received by patient: Acetaminophen with Propoxyphene HCL TAB; Chromium Picolinate; Depo-Provera; Vitamin B-Complex, Incl Combinations; Copper; Lutein; Selenium; Pycnogenol; COD-Liver OIL; Dextropropoxyphene Hydrochloride; Levothyroxine; Bendroflumethiazide; Garlic; Provera; Calcium Magnesium Zinc; Voltarol - Slow Release; Flecainide; Acetylsalicylic Acid; Ascorbic Acid; Vitamin D; Vitamin E; Glucosamine Sulfate; Ginkgo Biloba
Possible Arthrotec side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-24
Patient: male, weighing 83.9 kg (184.6 pounds)
Reactions: Malaise, Local Swelling, Hypoaesthesia
Drug(s) suspected as cause:
Arthrotec
Indication: Neck Pain
Arthrotec
Indication: Neck Injury
Arthrotec
Dosage: 75/200 mg, as needed
Administration route: Oral
Indication: Tendonitis
Start date: 2009-01-01
Norvasc
Dosage: 10 mg, daily
Indication: Hypertension
Start date: 2009-01-01
Other drugs received by patient: Tylenol; Lisinopril; Tylenol; Tylenol; Diovan; Tylenol; Gemfibrozil
Possible Arthrotec side effects in
Reported by a consumer/non-health professional from United States on 2012-07-23
Patient:
Reactions: Intervertebral Disc Protrusion, HIP Arthroplasty
Drug(s) suspected as cause:
Arthrotec
Dosage: unk
Lyrica
Dosage: unk
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: female
Reactions: Cataract
Drug(s) suspected as cause:
Arthrotec
Dosage: unk
Neurontin
Dosage: unk
Administration route: Oral
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: female
Reactions: Nausea, Oropharyngeal Pain
Drug(s) suspected as cause:
Arthrotec
Dosage: unk
Start date: 2006-01-01
Celecoxib
Dosage: unk
Start date: 2010-01-01
Xalatan
Dosage: unk
Start date: 2006-01-01
Zocor
Dosage: unk
Possible Arthrotec side effects in 65 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-19
Patient: 65 year old male
Reactions: Pneumonia, Condition Aggravated, Infectious Pleural Effusion
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arthrotec
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: female, weighing 65.0 kg (143.0 pounds)
Reactions: Petechiae
Drug(s) suspected as cause:
Arthrotec
Other drugs received by patient: Xanax; ESI; Ultram; Simvastatin; Cardiazem (Diltiazem Hydrochloride); Dexilant; Bentyl
Possible Arthrotec side effects in male
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: male
Reactions: Pain in Extremity, Upper Limb Fracture, Insomnia, Fall
Drug(s) suspected as cause:
Arthrotec
Dilantin
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-17
Patient: female
Reactions: Malaise, Impaired Work Ability, Mental Disorder
Drug(s) suspected as cause:
Arthrotec
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-11
Patient: female, weighing 100.0 kg (220.0 pounds)
Reactions: Arthropathy, Musculoskeletal Pain, Heart Rate Irregular
Drug(s) suspected as cause:
Arthrotec
Dosage: unk, twice daily
Administration route: Oral
Indication: Arthritis
Start date: 2009-01-01
End date: 2012-04-17
Arthrotec
Indication: Inflammation
Other drugs received by patient: Lipitor; Cymbalta
Possible Arthrotec side effects in
Reported by a consumer/non-health professional from United States on 2012-07-05
Patient:
Reactions: Fall
Drug(s) suspected as cause:
Arthrotec
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-02
Patient: female, weighing 64.9 kg (142.7 pounds)
Reactions: Rash Erythematous
Drug(s) suspected as cause:
Arthrotec
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-29
Patient: female
Reactions: Cerebrovascular Accident, Hypertension
Drug(s) suspected as cause:
Arthrotec
Possible Arthrotec side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-27
Patient: female, weighing 79.4 kg (174.6 pounds)
Reactions: Rash
Drug(s) suspected as cause:
Arthrotec
Other drugs received by patient: Lisinopril
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