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Simponi (Golimumab) - Malaise - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Malaise (31)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Simponi (Golimumab) where reactions include malaise. The selected reports were submitted to the FDA during the sample period of about a year.

 Reports 1 - 30 of 31   Next >>

Possible Simponi side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient: female, weighing 61.2 kg (134.7 pounds)

Reactions: Malaise, Lung Disorder, Chest Pain, Cough

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Vitamin; Calcium; Folic Acid



Possible Simponi side effects in female

Reported by a physician from Japan on 2012-08-14

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Malaise, C-Reactive Protein Increased, Pain in Extremity, Paraesthesia

Drug(s) suspected as cause:
Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2011-12-21

Simponi
    Start date: 2011-11-24

Other drugs received by patient: Selbex; Amlodipine; Loxonin; Alprazolam; Maglax; Merislon; Pitavastatin Calcium; Adenosine; Warfarin Potassium



Possible Simponi side effects in female

Reported by a physician from Japan on 2012-07-30

Patient: female

Reactions: Malaise, Hepatic Function Abnormal, Pneumonia, Arthralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Methotrexate
    Indication: Rheumatoid Arthritis
    Start date: 2012-05-02

Prednisolone
    Indication: Rheumatoid Arthritis
    Start date: 2012-05-02

Processe D Aconite Root
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-14

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2012-05-02
    End date: 2012-06-01

Other drugs received by patient: ALL Other Therapeutic Agents; Unasyn



Possible Simponi side effects in female

Reported by a physician from Japan on 2012-07-23

Patient: female

Reactions: Pneumonia, Malaise, Hepatic Function Abnormal, Arthralgia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2012-05-02
    End date: 2012-06-01

Prednisolone
    Indication: Rheumatoid Arthritis
    Start date: 2012-05-02

Processe D Aconite Root
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-14

Methotrexate
    Indication: Rheumatoid Arthritis
    Start date: 2012-05-02

Other drugs received by patient: Unasyn; ALL Other Therapeutic Agents



Possible Simponi side effects in female

Reported by a physician from Japan on 2012-07-11

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Malaise, C-Reactive Protein Increased, Pain in Extremity, Paraesthesia

Drug(s) suspected as cause:
Simponi
    Start date: 2011-11-24

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2011-12-21

Other drugs received by patient: Selbex; Maglax; Pitavastatin Calcium; Amlodipine; Alprazolam; Loxonin; Adenosine; Warfarin Potassium; Merislon



Possible Simponi side effects in female

Reported by a physician from Japan on 2012-07-10

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Malaise, Pain in Extremity, C-Reactive Protein Increased, Paraesthesia

Drug(s) suspected as cause:
Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2011-12-21

Simponi
    Start date: 2011-11-24

Other drugs received by patient: Selbex; Loxonin; Pitavastatin Calcium; Amlodipine; Alprazolam; Maglax; Adenosine; Warfarin Potassium; Merislon



Possible Simponi side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-06-21

Patient: female

Reactions: Productive Cough, Night Sweats, Pain, Headache, Pyrexia, Hyperhidrosis, Malaise, Fatigue, DRY Mouth, Liver Function Test Abnormal, Decreased Appetite, Nausea, Chromaturia, Eye Pain, Flushing, Dehydration, Mobility Decreased

Drug(s) suspected as cause:
Simponi
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-20

Simponi

Simponi
    Start date: 2012-05-20

Simponi
    Start date: 2011-11-17

Simponi
    Start date: 2012-04-20



Possible Simponi side effects in 37 year old female

Reported by a physician from Spain on 2012-06-11

Patient: 37 year old female

Reactions: Leukocytoclastic Vasculitis, Malaise

Drug(s) suspected as cause:
Simponi
    Start date: 2012-04-11

Simponi
    Indication: Ankylosing Spondylitis
    Start date: 2012-05-11



Possible Simponi side effects in male

Reported by a physician from Australia on 2012-06-08

Patient: male

Reactions: Multi-Organ Failure, Malaise, T-Cell Lymphoma, Hypotension, Pyrexia, Splenomegaly

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2012-03-13
    End date: 2012-04-13

Methotrexate
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 2011-08-19
    End date: 2012-04-20

Other drugs received by patient: Folic Acid; Allopurinol



Possible Simponi side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-30

Patient: female, weighing 70.5 kg (155.1 pounds)

Reactions: Abdominal Pain, Malaise, Foot Operation, Pain, Ear Pain, Oropharyngeal Pain, Constipation, Decreased Appetite

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in male

Reported by a physician from Australia on 2012-05-29

Patient: male

Reactions: Malaise, T-Cell Lymphoma, Hypotension, Pyrexia, Splenomegaly

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in

Reported by a pharmacist from Japan on 2012-05-25

Patient:

Reactions: Malaise, Interstitial Lung Disease, Hepatitis B, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Azulfidine



Possible Simponi side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-05-11

Patient: female

Reactions: Productive Cough, Night Sweats, Nausea, Pain, Chromaturia, Headache, Pyrexia, Fatigue, Malaise, Liver Function Test Abnormal, Dehydration, DRY Mouth, Mobility Decreased, Decreased Appetite

Drug(s) suspected as cause:
Simponi
    Start date: 2011-11-17

Simponi
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-20

Simponi
    Start date: 2012-04-20

Simponi



Possible Simponi side effects in male

Reported by a physician from Australia on 2012-05-10

Patient: male

Reactions: Malaise, Hypotension, Pyrexia, Lymphoma, Splenomegaly

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in

Reported by a pharmacist from Japan on 2012-05-03

Patient:

Reactions: Malaise, Interstitial Lung Disease, Hepatitis B, Decreased Appetite

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi

Other drugs received by patient: Azulfidine



Possible Simponi side effects in female

Reported by a physician from Japan on 2012-04-26

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Malaise, C-Reactive Protein Increased, Pain in Extremity, Paraesthesia

Drug(s) suspected as cause:
Simponi
    Start date: 2011-11-24

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2011-12-21

Other drugs received by patient: Selbex; Warfarin Sodium; Magnesium Sulfate; Pitavastatin Calcium; Amlodipine; Alprazolam; Loxonin; Adenosine; Merislon



Possible Simponi side effects in female

Reported by a physician from Japan on 2012-03-26

Patient: female, weighing 82.0 kg (180.4 pounds)

Reactions: Rhabdomyolysis, Malaise, C-Reactive Protein Increased, Pain in Extremity, Thyroid Mass, Paraesthesia, White Blood Cell Count Increased

Drug(s) suspected as cause:
Simponi
    Start date: 2011-11-24

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2011-12-21

Other drugs received by patient: Amlodipine; Alprazolam; Pitavastatin Calcium; Merislon; Warfarin Sodium; Selbex; Adenosine; Magnesium Sulfate; Loxonin



Possible Simponi side effects in female

Reported by a physician from Japan on 2012-03-22

Patient: female, weighing 37.2 kg (81.8 pounds)

Reactions: Malaise, Rhabdomyolysis, C-Reactive Protein Increased, Pain in Extremity, Thyroid Mass, Paraesthesia, White Blood Cell Count Increased

Drug(s) suspected as cause:
Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2011-12-21

Simponi
    Start date: 2011-11-24

Other drugs received by patient: Loxonin; Alprazolam; Adenosine; Magnesium Sulfate; Pitavastatin Calcium; Merislon; Warfarin Sodium; Amlodipine; Selbex



Possible Simponi side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-16

Patient: female, weighing 86.2 kg (189.6 pounds)

Reactions: Blood Pressure Increased, Nausea, Pain in Extremity, Malaise, Blood Cholesterol Increased, Thyroid Disorder, Asthenia, Arthritis

Drug(s) suspected as cause:
Simponi
    Indication: Rheumatoid Arthritis

Remicade
    Dosage: dose:700 or 800mg every 6-8 weeks. started 3-4 years ago
    Indication: Rheumatoid Arthritis

^arthritis Medicine^
    Indication: Arthritis

Remicade
    Start date: 2011-12-20

Antihypertension Medication
    Indication: Blood Pressure

Other drugs received by patient: Hydrocodone; Zyrtec; Omeprazole; Vitamin D



Possible Simponi side effects in female

Reported by a pharmacist from Ireland on 2012-02-09

Patient: female

Reactions: Malaise

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-01-19

Patient: female

Reactions: Night Sweats, Migraine, Malaise, Nausea, Diarrhoea, Musculoskeletal Pain, Psoriasis, Immediate Post-Injection Reaction

Drug(s) suspected as cause:
Simponi

Simponi
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-03



Possible Simponi side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2012-01-18

Patient: female

Reactions: Vomiting, Increased Appetite, Nausea, Rash, Headache, Pyrexia, Malaise, Fatigue, Arthralgia, Dizziness, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi
    Start date: 2011-12-23

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2011-11-04

Simponi
    Start date: 2011-12-23

Simponi
    Indication: Ankylosing Spondylitis
    Start date: 2011-11-04



Possible Simponi side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-16

Patient: female

Reactions: Malaise

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-01-06

Patient: female

Reactions: Migraine, Night Sweats, Nausea, Musculoskeletal Pain, Psoriasis, Immediate Post-Injection Reaction, Malaise, Diarrhoea

Drug(s) suspected as cause:
Simponi
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-12-03

Simponi



Possible Simponi side effects in 76 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-27

Patient: 76 year old female, weighing 56.7 kg (124.7 pounds)

Reactions: Malaise, Dyspnoea, Dysphagia, Mouth Ulceration, Anal Abscess

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in female

Reported by a pharmacist from United States on 2011-12-23

Patient: female, weighing 102.1 kg (224.5 pounds)

Reactions: Product Formulation Issue, Product Quality Issue, Drug Dose Omission, Inappropriate Schedule of Drug Administration, Wrong Technique in Drug Usage Process, Vomiting, Pain, Rash, Malaise, Oedema Peripheral, Insomnia

Drug(s) suspected as cause:
Duragesic-100
    Indication: Back Pain

Duragesic-100
    Start date: 2004-01-01

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2010-08-01

Fentanyl
    Indication: Back Pain

Other drugs received by patient: Methotrexate; Spironolactone; Lexapro; Methotrexate; Aspirin; Hydroxychloroquine; Neurontin; Cymbalta; Sulfazine; Sulfazine; Nasal Spray NOS



Possible Simponi side effects in female

Reported by a consumer/non-health professional from United States on 2011-11-16

Patient: female

Reactions: Confusional State, Malaise

Drug(s) suspected as cause:
Simponi



Possible Simponi side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-11-04

Patient: female

Reactions: Malaise, Fatigue, Blood Urine Present, Dysuria, DRY Mouth, Abdominal Distension, Abdominal Tenderness

Drug(s) suspected as cause:
Simponi
    Start date: 2011-10-16

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2011-07-16

Other drugs received by patient: Actonel; Methotrexate; Prednisone



Possible Simponi side effects in female

Reported by a health professional (non-physician/pharmacist) from Australia on 2011-10-28

Patient: female

Reactions: Fatigue, Malaise, Blood Urine Present, Dysuria, DRY Mouth, Abdominal Distension, Abdominal Tenderness

Drug(s) suspected as cause:
Simponi
    Start date: 2011-10-16

Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2011-07-16

Other drugs received by patient: Actonel; Prednisone; Methotrexate



Possible Simponi side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-19

Patient: female

Reactions: Dyspnoea, Pain in Extremity, Nasal Congestion, Oropharyngeal Pain, Hyperhidrosis, Abdominal Pain Upper, Anxiety, Malaise, Oedema Peripheral, Cough

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Simponi
    Start date: 2011-06-27

Simponi
    Start date: 2011-08-31

Simponi
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-29



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