This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Etodolac 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 (79)
Death (17)
Life Threatening Events (9)
Reports by Reaction Type
Pyrexia (8),
Pneumonia (8),
Asthenia (6),
Fatigue (5),
Completed Suicide (5),
Neoplasm Malignant (5),
Asthma (4),
Drug Ineffective (4),
Urticaria (4),
Neoplasm Progression (4),
Colitis Microscopic (4),
Death (4)
Below are a few examples of reports where side effects / adverse reactions may be related to Etodolac. For a complete list or a specific selection of reports, please use the links above.
Possible Etodolac side effects in male
Reported by a physician from Japan on 2012-08-23
Patient: male, weighing 50.0 kg (110.0 pounds)
Reactions: Renal Impairment, C-Reactive Protein Increased, Neoplasm Malignant, Neoplasm Progression, Pyrexia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Zometa
Dosage: unk ukn, unk
Indication: Metastatic Renal Cell Carcinoma
Start date: 2011-06-27
Afinitor
Dosage: 5 mg, daily
Administration route: Oral
Start date: 2012-01-06
End date: 2012-01-09
Etodolac
Dosage: 400 mg, daily
Administration route: Oral
Indication: Metastatic Renal Cell Carcinoma
Afinitor
Dosage: 5 mg, daily
Administration route: Oral
Start date: 2011-12-14
End date: 2011-12-29
Prednisolone
Dosage: 5 mg
Administration route: Oral
Indication: Metastatic Renal Cell Carcinoma
Start date: 2011-06-21
End date: 2011-09-01
Afinitor
Dosage: 10 mg, daily
Administration route: Oral
Indication: Metastatic Renal Cell Carcinoma
Start date: 2011-06-20
End date: 2011-10-03
Other drugs received by patient: Allopurinol; Benidipine Hydrochloride; Vitamin B12; Limaprost Alfadex; Lansoprazole; Limaprost Alfadex; Flivas; Acetaminophen
Possible Etodolac side effects in 50 year old female
Reported by a physician from Japan on 2012-08-16
Patient: 50 year old female
Reactions: Overdose, Hallucination, Visual, Emotional Disorder, Toxicity To Various Agents, Altered State of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lyrica
Administration route: Oral
Levotomin
Administration route: Oral
Etodolac
Administration route: Oral
Possible Etodolac side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-13
Patient: female, weighing 108.9 kg (239.5 pounds)
Reactions: Asthma, Rheumatoid Arthritis, Peroneal Nerve Palsy, Memory Impairment, Feeling Abnormal, Spinal Column Stenosis
Drug(s) suspected as cause:
Bromide
Indication: Asthma
Remicade
Dosage: every 7-8 weeks
Indication: Rheumatoid Arthritis
Etodolac
Administration route: Oral
Indication: Rheumatoid Arthritis
Qvar 40
Indication: Asthma
Other drugs received by patient: Folic Acid; Levoxyl; Atenolol; Adalat; Lipitor; Metformin Hydrochloride; Methotrexate Sodium
Possible Etodolac side effects in female
Reported by a physician from United States on 2012-08-02
Patient: female, weighing 45.4 kg (99.9 pounds)
Reactions: Impaired Healing, DRY Skin, Genital Cyst, Tenderness, Genital Infection, Papule
Drug(s) suspected as cause:
Etodolac
Indication: Papule
Start date: 2012-06-01
Etodolac
Indication: DRY Skin
Humira
Indication: Crohn's Disease
Start date: 2012-05-09
Other drugs received by patient: Avathioprine
Possible Etodolac side effects in 34 year old male
Reported by a pharmacist from United States on 2012-07-26
Patient: 34 year old male
Reactions: Liver Function Test Abnormal, Pancytopenia, Headache, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Etodolac
Possible Etodolac side effects in 58 year old female
Reported by a consumer/non-health professional from United States on 2012-07-19
Patient: 58 year old female, weighing 62.6 kg (137.7 pounds)
Reactions: Fatigue, Pancreatic Carcinoma, Hepatitis
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Etodolac
Possible Etodolac side effects in 51 year old male
Reported by a consumer/non-health professional from United States on 2012-07-18
Patient: 51 year old male, weighing 87.5 kg (192.6 pounds)
Reactions: Night Sweats, Muscle Atrophy, Swelling Face, Body FAT Disorder, CD4 Lymphocytes Decreased, Pneumonia, Abnormal Behaviour, Rash, Amnesia, Malaise, Mood Altered, Oedema Peripheral, Hiccups, Bronchitis, Candidiasis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Etodolac
Possible Etodolac side effects in 83 year old female
Reported by a consumer/non-health professional from United States on 2012-07-11
Patient: 83 year old female, weighing 70.3 kg (154.7 pounds)
Reactions: Liver Injury, Chills, Musculoskeletal Chest Pain, Pyrexia, Hepatic Enzyme Increased, Fatigue, Malaise, Asthenia
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Etodolac
Possible Etodolac side effects in female
Reported by a physician from Japan on 2012-07-11
Patient: female, weighing 42.0 kg (92.4 pounds)
Reactions: Pneumonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Methotrexate
Dosage: started before 20-jan-2006
Administration route: Oral
Indication: Rheumatoid Arthritis
Prednisolone
Administration route: Oral
Indication: Rheumatoid Arthritis
Remicade
Start date: 2008-09-08
Etodolac
Administration route: Oral
Indication: Rheumatoid Arthritis
Remicade
Indication: Rheumatoid Arthritis
Start date: 2008-08-25
Remicade
Dosage: 20th infusion
Start date: 2012-01-06
Remicade
Start date: 2012-04-12
Possible Etodolac side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-09
Patient: female, weighing 45.4 kg (99.9 pounds)
Reactions: Impaired Healing, Tenderness, DRY Skin, Genital Cyst, Genital Infection, Papule
Drug(s) suspected as cause:
Etodolac
Indication: DRY Skin
Humira
Indication: Crohn's Disease
Start date: 2012-05-09
Etodolac
Indication: Milia
Start date: 2012-06-01
Other drugs received by patient: Avathioprine
Possible Etodolac side effects in male
Reported by a physician from Japan on 2012-07-02
Patient: male, weighing 50.0 kg (110.0 pounds)
Reactions: Death, Renal Impairment, Neoplasm Malignant, C-Reactive Protein Increased, Neoplasm Progression, Pyrexia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Afinitor
Dosage: 10 mg, daily
Administration route: Oral
Indication: Metastatic Renal Cell Carcinoma
Start date: 2011-06-20
End date: 2011-10-03
Zometa
Dosage: unk ukn, unk
Indication: Metastatic Renal Cell Carcinoma
Start date: 2011-06-27
Prednisolone Sodium Succinate INJ
Dosage: 5 mg
Administration route: Oral
Indication: Metastatic Renal Cell Carcinoma
Start date: 2011-06-21
End date: 2011-09-01
Afinitor
Dosage: 5 mg, daily
Administration route: Oral
Start date: 2011-12-14
End date: 2011-12-29
Afinitor
Dosage: 5 mg, daily
Administration route: Oral
Start date: 2012-01-06
End date: 2012-01-09
Etodolac
Dosage: 400 mg, daily
Administration route: Oral
Indication: Metastatic Renal Cell Carcinoma
Other drugs received by patient: Lansoprazole; Limaprost Alfadex; Flivastatin Sodium; Allopurinol; Vitamin B12; Limaprost Alfadex; Benidipine Hydrochloride; Acetaminophen
Possible Etodolac side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient: female
Reactions: Asthma, Abdominal Discomfort, Fatigue, Temporomandibular Joint Syndrome, Chest Pain, Insomnia, Ear Pain, Blood Glucose Increased, Cough, Influenza Like Illness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rebif
Indication: Multiple Sclerosis
Start date: 2009-06-10
Etodolac
Indication: Pain
Possible Etodolac side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-20
Patient: female, weighing 54.4 kg (119.7 pounds)
Reactions: Back Pain, Vomiting Projectile, Condition Aggravated, Drug Interaction, Headache, Malaise, Hot Flush, Activities of Daily Living Impaired, Diarrhoea, Nervous System Disorder, Asthenia, Frustration
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Etodolac
Possible Etodolac side effects in female
Reported by a individual with unspecified qualification from United States on 2012-06-15
Patient: female, weighing 59.0 kg (129.7 pounds)
Reactions: Product Quality Issue, Diarrhoea, Skin Ulcer, Drug Ineffective, Product Taste Abnormal, Abdominal Pain Upper
Drug(s) suspected as cause:
Etodolac
Possible Etodolac side effects in 50 year old female
Reported by a physician from Japan on 2012-06-11
Patient: 50 year old female, weighing 51.0 kg (112.2 pounds)
Reactions: Intentional Overdose, Toxicity To Various Agents, Delirium, Left Ventricular Dysfunction, Hallucinations, Mixed, Pulmonary Oedema, Multiple Drug Overdose Intentional, Suicide Attempt, Emotional Disorder, Altered State of Consciousness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Levotomin
Dosage: unk
Administration route: Oral
End date: 2012-03-29
Etodolac
Dosage: unk
Administration route: Oral
End date: 2012-03-29
Lyrica
Dosage: unk
Administration route: Oral
Indication: Back Pain
End date: 2012-03-29
Possible Etodolac side effects in 54 year old male
Reported by a physician from United States on 2012-05-29
Patient: 54 year old male, weighing 84.4 kg (185.6 pounds)
Reactions: Night Sweats, Pneumonia, Nausea, Abnormal Behaviour, Disorientation, Rash, Amnesia, Mood Altered, Oedema Peripheral, Hiccups, Disturbance in Attention, Bronchitis, Candidiasis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Etodolac
Possible Etodolac side effects in female
Reported by a physician from Japan on 2012-05-25
Patient: female, weighing 50.0 kg (110.0 pounds)
Reactions: Activated Partial Thromboplastin Time Prolonged, Rectal Haemorrhage, International Normalised Ratio Increased, Rectal Ulcer, Blood Creatinine Increased, Melaena
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Trichlormethiazide
Dosage: 1 mg
Administration route: Oral
Start date: 2012-03-02
End date: 2012-04-18
Pradaxa
Dosage: 220 mg
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-03-30
End date: 2012-04-18
Torsemide
Dosage: 4 mg
Administration route: Oral
Start date: 2012-03-29
End date: 2012-04-18
Etodolac
Dosage: 400 mg
Administration route: Oral
Start date: 2012-03-07
End date: 2012-04-18
Lasix
Dosage: 4 mg
Administration route: Oral
Start date: 2012-03-02
End date: 2012-04-18
Other drugs received by patient: Progogue D; Magnesium Oxide; Nexium; Depas; Rozerem; Rivastach; Norvasc
Possible Etodolac side effects in 69 year old female
Reported by a physician from Denmark on 2012-05-24
Patient: 69 year old female, weighing 68.0 kg (149.6 pounds)
Reactions: Breast Cancer Female
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Etodolac
Dosage: 200 mg, 2x/day
Indication: Osteoarthritis
Start date: 2010-09-02
NO Subject Drug
Dosage: no dose given
Administration route: Oral
Indication: Osteoarthritis
Start date: 2010-09-02
Possible Etodolac side effects in 50 year old female
Reported by a physician from Japan on 2012-05-18
Patient: 50 year old female, weighing 51.0 kg (112.2 pounds)
Reactions: Hallucinations, Mixed, Left Ventricular Dysfunction, Intentional Overdose, Suicide Attempt, Emotional Disorder, Altered State of Consciousness, Delirium
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Etodolac
Dosage: unk
Administration route: Oral
End date: 2012-03-29
Levotomin
Dosage: unk
Administration route: Oral
End date: 2012-03-29
Lyrica
Dosage: unk
Administration route: Oral
Indication: Back Pain
End date: 2012-03-29
Possible Etodolac side effects in 30 year old male
Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-05-08
Patient: 30 year old male
Reactions: Drug Eruption
Adverse event resulted in: death
Drug(s) suspected as cause:
Etodolac
Dosage: 750 mg, unk
Administration route: Oral
Indication: Allergy Test
Etodolac
Dosage: unk
Indication: Product Used FOR Unknown Indication
Possible Etodolac side effects in 16 year old female
Reported by a physician from Switzerland on 2012-04-18
Patient: 16 year old female
Reactions: Vomiting, Mydriasis, Dyskinesia, Coma, Epilepsy, Tremor, Hypokalaemia, Hepatic Enzyme Increased, Poisoning, Drug Administered To Patient of Inappropriate AGE, Suicide Attempt, Hypocalcaemia, Extrapyramidal Disorder, Multiple Drug Overdose, Hypertonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Bisacodyl
Dosage: unk;unk
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-22
End date: 2012-01-22
Remeron
Dosage: 10 df;once;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-22
End date: 2012-01-22
Mefenamic Acid
Dosage: unk;unk
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-22
End date: 2012-01-22
Pregabalin
Dosage: unk;unk
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-22
End date: 2012-01-22
Etodolac
Dosage: unk;unk
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-22
End date: 2012-01-22
Bupropion HCL
Dosage: 6 df;once;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-22
End date: 2012-01-22
Trazodone HCL
Dosage: 60 df;once;po, 18 df;once;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-22
End date: 2012-01-22
Trazodone HCL
Dosage: 60 df;once;po, 18 df;once;po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-01-22
End date: 2012-01-22
Possible Etodolac side effects in 73 year old female
Reported by a consumer/non-health professional from United States on 2012-04-11
Patient: 73 year old female, weighing 88.6 kg (194.9 pounds)
Reactions: Pruritus, Hypersensitivity, Palpitations, Urticaria, Rash Morbilliform, Erythema
Drug(s) suspected as cause:
Etodolac
Dosage: 500 mg twice daily for 7 days ; 500 mg once daily remaining supply
Indication: Arthralgia
Start date: 2012-03-14
End date: 2012-03-21
Etodolac
Dosage: 500 mg twice daily for 7 days ; 500 mg once daily remaining supply
Indication: Joint Swelling
Start date: 2012-03-14
End date: 2012-03-21
Possible Etodolac side effects in 77 year old male
Reported by a pharmacist from Japan on 2012-04-09
Patient: 77 year old male
Reactions: Neoplasm Malignant, Asthenia
Adverse event resulted in: death
Drug(s) suspected as cause:
Etodolac
Dosage: 400mg, daily
Administration route: Oral
Indication: Cancer Pain
Start date: 2010-01-11
Lyrica
Dosage: 150mg, daily
Administration route: Oral
Indication: Cancer Pain
Start date: 2011-02-15
End date: 2012-02-29
Morphine Sulfate
Dosage: 30mg, daily
Administration route: Oral
Indication: Cancer Pain
Start date: 2010-01-11
Possible Etodolac side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-06
Patient:
Reactions: Death
Adverse event resulted in: death
Drug(s) suspected as cause:
Etodolac
Possible Etodolac side effects in 77 year old male
Reported by a pharmacist from Japan on 2012-04-05
Patient: 77 year old male
Reactions: Neoplasm Malignant, Drug Interaction, Neoplasm Progression, Asthenia
Adverse event resulted in: death
Drug(s) suspected as cause:
Etodolac
Other drugs received by patient possibly interacting with the suspect drug: Lyrica
Dosage: 150mg, daily
Administration route: Oral
Indication: Cancer Pain
Start date: 2011-02-15
End date: 2011-02-28
Morphine Sulfate
Dosage: 30mg, daily
Administration route: Oral
Indication: Cancer Pain
Start date: 2010-01-11
Possible Etodolac side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-04
Patient:
Reactions: Overdose
Adverse event resulted in: death
Drug(s) suspected as cause:
Trazodone Methocarbamol
Diazepam
Hydroxyzine Pamoate
Etodolac
Buspirone HCL
Methadone HCL
Possible Etodolac side effects in 50 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-04
Patient: 50 year old male
Reactions: Completed Suicide
Adverse event resulted in: death
Drug(s) suspected as cause:
Etodolac
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Hydrocodone Bitartrate
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Acetaminophen
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Cyclobenzaprine HCL
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Etodolac side effects in 77 year old male
Reported by a pharmacist from Japan on 2012-04-02
Patient: 77 year old male
Reactions: Death, Drug Interaction, Asthenia
Adverse event resulted in: death
Drug(s) suspected as cause:
Etodolac
Other drugs received by patient possibly interacting with the suspect drug: Morphine Sulfate
Dosage: 30mg, daily
Administration route: Oral
Indication: Cancer Pain
Start date: 2010-01-11
Lyrica
Dosage: 150mg, daily
Administration route: Oral
Indication: Cancer Pain
Start date: 2011-02-15
End date: 2011-02-28
Possible Etodolac side effects in 63 year old male
Reported by a consumer/non-health professional from United States on 2012-03-27
Patient: 63 year old male, weighing 74.8 kg (164.7 pounds)
Reactions: Product Substitution Issue, Drug Ineffective
Drug(s) suspected as cause:
Etodolac
Possible Etodolac side effects in 75 year old male
Reported by a consumer/non-health professional from United States on 2012-03-26
Patient: 75 year old male, weighing 98.9 kg (217.5 pounds)
Reactions: Drug Ineffective, Blood Pressure Fluctuation, Brain Neoplasm, Blood Creatinine Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lodine
Indication: Arthritis
Etodolac
Indication: Arthritis
Other drugs received by patient: Unspecified Unknown Medications; Unspecified Blood Pressure Medications (NO Pref. Name)
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