This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Orencia (Abatacept) 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 (1600)
Death (102)
Life Threatening Events (53)
Disability (15)
Reports by Reaction Type
Drug Ineffective (115),
Headache (87),
Fatigue (83),
Nausea (62),
Pneumonia (59),
Dyspnoea (50),
Circumstance or Information Capable of Leading To Medication Error (49),
Diarrhoea (49),
Incorrect Storage of Drug (47),
Interstitial Lung Disease (45),
Rheumatoid Arthritis (40),
Medication Error (40)
Below are a few examples of reports where side effects / adverse reactions may be related to Orencia (Abatacept). For a complete list or a specific selection of reports, please use the links above.
Possible Orencia side effects in 63 year old female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: 63 year old female
Reactions: Urinary Tract Infection, Pathological Fracture
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orencia
Indication: Rheumatoid Arthritis
Start date: 2011-07-01
Prednisone TAB
Indication: Rheumatoid Arthritis
Possible Orencia side effects in 54 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-27
Patient: 54 year old female
Reactions: Cholelithiasis
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Sulfasalazine; Naproxen; Triamterene HCL; Pantoprazole Sodium; Tevapirin; Leucovorin Calcium; Fenofibrate; Alendronate Sodium
Possible Orencia side effects in 33 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-26
Patient: 33 year old female
Reactions: Stomatitis, Arthralgia, Infertility
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Folic Acid; Methotrexate; Synthroid; Prednisone TAB; Plaquenil
Possible Orencia side effects in 87 year old female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-24
Patient: 87 year old female, weighing 98.0 kg (215.6 pounds)
Reactions: Pneumonia, Tachycardia, Oedema Peripheral, Lower Respiratory Tract Infection
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Sertraline Hydrochloride; Allopurinol; Simvastatin; Warfarin Sodium; Zolpidem; Aldactone; Vitamin D; Levothyroxine Sodium; Digoxin; Furosemide; Calcium Carbonate
Possible Orencia side effects in 45 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-24
Patient: 45 year old female
Reactions: Blood Pressure Increased, Generalised Erythema
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Plaquenil; Vitamin D; Folic Acid; Hydromorphone Hydrochloride; Prednisone TAB; Methotrexate; Alendronate Sodium; Dexlansoprazole
Possible Orencia side effects in 48 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 48 year old female, weighing 58.0 kg (127.6 pounds)
Reactions: Depression
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Prednisone TAB
Possible Orencia side effects in 61 year old female
Reported by a consumer/non-health professional from Canada on 2012-08-24
Patient: 61 year old female
Reactions: Vomiting, Nausea, Mass, Dyspepsia, Cardiomegaly
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Prednisone TAB; Salmon OIL; Vitamin D; Milk Thistle; Methotrexate; Temazepam; Zinc Sulfate; Oxycodone HCL; Flaxseed OIL
Possible Orencia side effects in 53 year old female
Reported by a physician from France on 2012-08-24
Patient: 53 year old female
Reactions: Cardiac Tamponade, Pericarditis, Progressive Multifocal Leukoencephalopathy
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Start date: 2009-01-01
Orencia
Dosage: 250 mg powder concentrate for solution for infusion
Start date: 2012-03-01
End date: 2012-06-30
Prednisone TAB
Dosage: 20 mg (prednisone) 1/d or 1.5/d
End date: 2012-07-01
Other drugs received by patient: Atorvastatin; Fosavance; Metformin HCL; Nexium
Possible Orencia side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 65 year old female
Reactions: Arthralgia, Cerebrovascular Accident
Drug(s) suspected as cause:
Orencia
Possible Orencia side effects in 72 year old male
Reported by a consumer/non-health professional from United States on 2012-08-24
Patient: 72 year old male, weighing 88.0 kg (193.6 pounds)
Reactions: Insomnia, Prostatic Disorder
Drug(s) suspected as cause:
Orencia
Possible Orencia side effects in 34 year old male
Reported by a consumer/non-health professional from France on 2012-08-24
Patient: 34 year old male
Reactions: Psoriasis
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Methotrexate
Possible Orencia side effects in 24 year old female
Reported by a consumer/non-health professional from Japan on 2012-08-24
Patient: 24 year old female, weighing 52.0 kg (114.4 pounds)
Reactions: Colitis Ulcerative
Drug(s) suspected as cause:
Orencia
Dosage: sc,125mg/dose from 09jul2010-15dec2011.
Indication: Rheumatoid Arthritis
Start date: 2012-01-13
End date: 2012-05-18
Rheumatrex
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2010-03-18
End date: 2012-06-22
Other drugs received by patient: Mucosta; Folic Acid; Loxonin
Possible Orencia side effects in 82 year old female
Reported by a consumer/non-health professional from Sweden on 2012-08-24
Patient: 82 year old female
Reactions: Large Intestinal Ulcer Haemorrhage, Diverticulitis
Drug(s) suspected as cause:
Methotrexate
Orencia
Possible Orencia side effects in 70 year old female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-24
Patient: 70 year old female
Reactions: Fatigue, Anaemia, Mouth Ulceration, Gastrointestinal Disorder, Influenza Like Illness
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Folic Acid; Aspirin; Metformin HCL; Methotrexate; Furosemide; Atenolol; Lipitor; Prednisolone; Actonel; Calcium; Meloxicam; Nexium; Folic Acid; Prednisone TAB; Humalog
Possible Orencia side effects in 48 year old female
Reported by a consumer/non-health professional from Japan on 2012-08-23
Patient: 48 year old female, weighing 50.0 kg (110.0 pounds)
Reactions: Arthropathy
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Methotrexate; Laxoberon; Zyrtec; Voltaren; Folic Acid; Prednisolone; Teprenone; Maglax
Possible Orencia side effects in 58 year old female
Reported by a consumer/non-health professional from Canada on 2012-08-22
Patient: 58 year old female
Reactions: Localised Infection, Nausea, Paralysis, Cystitis, Rheumatoid Arthritis, Diarrhoea, Dehydration, Kidney Infection, Cardiac Arrest, Asthenia
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Rabeprazole Sodium; Adalat; Flexeril; Vitamin D; NPH Insulin; Percocet; Arava; Iron; Altace; Vitamin B-12; Humira; Tylenol; Bisoprolol Fumarate; Prednisone TAB; Viokase 16; Prezista; Pantoprazole Sodium; Ibuprofen
Possible Orencia side effects in 36 year old female
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-22
Patient: 36 year old female, weighing 91.0 kg (200.2 pounds)
Reactions: Ocular Hyperaemia, Eye Swelling, DRY Eye, Vertigo Positional
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Acetaminophen W / Codeine; Ventolin; Fluticasone Propionate / Salmeterol; Rabeprazole Sodium; Folic Acid; Prochlorperazine; Methotrexate
Possible Orencia side effects in 63 year old female
Reported by a physician from Japan on 2012-08-22
Patient: 63 year old female
Reactions: Cerebral Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Methotrexate; Loxonin; Lansoprazole; Celecoxib; Irsogladine Maleate; Prednisone TAB; Folic Acid; Alendronate Sodium
Possible Orencia side effects in 84 year old female
Reported by a consumer/non-health professional from Canada on 2012-08-21
Patient: 84 year old female
Reactions: Transient Ischaemic Attack, Herpes Zoster
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Plaquenil; Arava; Atenolol
Possible Orencia side effects in 70 year old female
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: 70 year old female
Reactions: Drug Dose Omission, Pain, Headache, Cardiac Disorder, Rheumatoid Arthritis, Arthropathy, Arthralgia, Oedema Peripheral, Musculoskeletal Stiffness, Carpal Tunnel Syndrome, Depression, Influenza
Drug(s) suspected as cause:
Orencia
Possible Orencia side effects in 66 year old female
Reported by a consumer/non-health professional from Japan on 2012-08-21
Patient: 66 year old female
Reactions: Parkinson's Disease
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Livalo
Possible Orencia side effects in 61 year old male
Reported by a health professional (non-physician/pharmacist) from Australia on 2012-08-21
Patient: 61 year old male, weighing 76.0 kg (167.2 pounds)
Reactions: Skin Cancer, Cardiac Disorder
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Warfarin Sodium; Prednisolone; Lasix; Sotalol HCL; Gemfibrozil
Possible Orencia side effects in 72 year old female
Reported by a physician from Canada on 2012-08-21
Patient: 72 year old female
Reactions: Abdominal Pain, Weight Decreased, Tinnitus, Onychoclasis, Vomiting, Nausea, Urinary Tract Infection, Bursitis, Intestinal Obstruction, Wound Complication, Haemoglobin Decreased, Diarrhoea, Visual Impairment, Sleep Apnoea Syndrome, Asthenia, Inflammation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Arava
Cymbalta
Dilaudid
Lyrica
Dosage: also taken 150mg
Orencia
Dosage: lastdose20oct11,15dec11,16dec11,7feb12,6mar12,13jul12 inf:11,57-500mg-q4wk,exp:ma2014,sep14
Indication: Rheumatoid Arthritis
Start date: 2011-08-01
Prednisone TAB
Dosage: also taken 15 mg
Other drugs received by patient: Nexium; Hydromorphone Hydrochloride; Alendronate Sodium; Pramipexole Dihydrochloride; Calcium; Atenolol; Acetaminophen; Oxybutynin; Amiloride Hydrochloride; Calcitonin Salmon; Naproxen
Possible Orencia side effects in 65 year old female
Reported by a consumer/non-health professional from France on 2012-08-20
Patient: 65 year old female
Reactions: Rash, Rash Maculo-Papular, Pemphigoid
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Duragesic-100; Actonel; Dafalgan Codeine Tabs; Prednisone TAB; Potassium Chloride; Amiodarone HCL; Omeprazole; Calcium Carbonate + Colecalciferol; Symbicort; Previscan
Possible Orencia side effects in 50 year old female
Reported by a consumer/non-health professional from Canada on 2012-08-17
Patient: 50 year old female
Reactions: Asthma, Syncope, Chest Pain, Abscess, Bronchitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Methotrexate; Micardis; Prednisone TAB; Celebrex; Singulair; Acetaminophen; Maxalt; Enbrel; Nexium
Possible Orencia side effects in 66 year old female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 66 year old female
Reactions: Drug Ineffective, Crohn's Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orencia
Possible Orencia side effects in 59 year old female
Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-17
Patient: 59 year old female
Reactions: Blood Pressure Increased, Fatigue, Kidney Infection, Metabolic Encephalopathy, Epistaxis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orencia
Dosage: 41 infusions
Indication: Rheumatoid Arthritis
Start date: 2008-09-04
End date: 2012-07-13
Orencia
Dosage: 41 infusions
Start date: 2008-09-04
End date: 2012-07-13
Orencia
Plavix
Other drugs received by patient: Adalat; Ciclesonide; Singulair; Clonazepam; Albuterol Sulate; Synthroid; Ramipril; Novorapid; Lantus
Possible Orencia side effects in 72 year old male
Reported by a consumer/non-health professional from Canada on 2012-08-17
Patient: 72 year old male
Reactions: Colon Cancer, Septic Shock, Immobile
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Methotrexate
Orencia
Indication: Rheumatoid Arthritis
Start date: 2010-01-01
End date: 2012-04-02
Prednisone TAB
Other drugs received by patient: Metformin HCL; Folic Acid; Verapamil; Glyburide; Vitamin B-12; Rivasa; Avalide; Coumadin; Lipitor
Possible Orencia side effects in 63 year old female
Reported by a physician from Japan on 2012-08-16
Patient: 63 year old female
Reactions: Cerebral Haemorrhage
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Irsogladine Maleate; Methotrexate; Folic Acid; Prednisone TAB; Loxonin; Celecoxib; Lansoprazole; Alendronate Sodium
Possible Orencia side effects in 66 year old female
Reported by a consumer/non-health professional from Japan on 2012-08-16
Patient: 66 year old female
Reactions: Parkinson's Disease
Drug(s) suspected as cause:
Orencia
Other drugs received by patient: Livalo
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