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Etodolac (Etodolac) - Side Effect Reports to FDA

 
 



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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