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Copaxone (Glatiramer) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Copaxone (Glatiramer) 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 (1366)
Death (44)
Life Threatening Events (40)
Disability (16)

Reports by Reaction Type

Multiple Sclerosis Relapse (136)Dyspnoea (107)Urticaria (69)Injection Site Pain (52)Convulsion (51)Nausea (48)Injection Site Reaction (46)Flushing (44)Chest Pain (42)Immediate Post-Injection Reaction (41)Erythema (39)Chest Discomfort (39)

Below are a few examples of reports where side effects / adverse reactions may be related to Copaxone (Glatiramer). For a complete list or a specific selection of reports, please use the links above.

Possible Copaxone side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: male

Reactions: Congenital Heart Valve Disorder

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27

Patient: male

Reactions: Central Nervous System Infection, Fall

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a physician from Canada on 2012-08-24

Patient: female

Reactions: Drug Ineffective, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Copaxone
    Indication: Multiple Sclerosis

Gilenya
    Indication: Relapsing-Remitting Multiple Sclerosis
    Start date: 2011-10-14



Possible Copaxone side effects in 61 year old male

Reported by a pharmacist from United States on 2012-08-24

Patient: 61 year old male

Reactions: Pruritus, Dyspnoea, Vision Blurred, Throat Tightness, Hyperhidrosis, Feeling Abnormal

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: male

Reactions: Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Flushing, Dyspnoea, Feeling Hot

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a physician from United States on 2012-08-24

Patient: female

Reactions: Hepatic Enzyme Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24

Patient: female

Reactions: Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

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

Patient: female

Reactions: Leukaemia

Drug(s) suspected as cause:
Copaxone

Other drugs received by patient: Lyrica; Colace; Citrucel; Glycolax; Zocor; Prozac; Oxytriol Patch; Vicodin



Possible Copaxone side effects in female

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

Patient: female

Reactions: Bedridden, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient: female

Reactions: Injury Associated With Device

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

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

Patient: female

Reactions: Staphylococcal Infection, Ear Infection, Tympanic Membrane Perforation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient: female

Reactions: Urinary Tract Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male

Reactions: Homicide, Fatigue, Psychotic Disorder

Drug(s) suspected as cause:
Copaxone

Other drugs received by patient: Viagra; Tramadol HCL; Hydrocodone; Trazodone Hydrochloride; Amantadine HCL; Toradol



Possible Copaxone side effects in female

Reported by a physician from United States on 2012-08-22

Patient: female

Reactions: Smear Cervix Abnormal

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a physician on 2012-08-22

Patient: female

Reactions: Soft Tissue Injury

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female

Reactions: Flushing, Back Pain, Dizziness, Tremor

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: male

Reactions: Wound, Cerebrovascular Accident

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in 41 year old male

Reported by a individual with unspecified qualification from United States on 2012-08-21

Patient: 41 year old male

Reactions: Dyspnoea, Feeling Hot, Nervous System Disorder, Erythema

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: female

Reactions: Furuncle, Feeling Hot, Abscess Limb

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male

Reactions: LIP Swelling, Pruritus, Urticaria, Oedema Peripheral, Eye Swelling, Swollen Tongue

Drug(s) suspected as cause:
Copaxone

Other drugs received by patient: Benicar; Lexapro



Possible Copaxone side effects in female

Reported by a pharmacist from United States on 2012-08-21

Patient: female

Reactions: Incorrect Route of Drug Administration, Dyspnoea, Throat Tightness

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Drug Effect Decreased, Malaise, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: female

Reactions: Knee Arthroplasty

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in 55 year old female

Reported by a pharmacist from United States on 2012-08-21

Patient: 55 year old female

Reactions: Injection Site Swelling

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-21

Patient: female

Reactions: Injection Site Necrosis, Lymphadenitis, Urticaria, Erythema

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-20

Patient: female

Reactions: Hypersensitivity, Pain in Extremity, Bladder Dysfunction, Muscular Weakness, Multiple Sclerosis Relapse

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Multiple Sclerosis Relapse

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a individual with unspecified qualification from United States on 2012-08-20

Patient: female, weighing 54.4 kg (119.7 pounds)

Reactions: Dyspnoea, Oedema Peripheral, Drug Hypersensitivity, Rash

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Copaxone



Possible Copaxone side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-20

Patient: female

Reactions: Injection Site Pain

Drug(s) suspected as cause:
Copaxone

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