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Multiple Sclerosis
Suspicious papanicolaou
smears (pap smears) and vaginal haemorrhage were reported as frequent
post marketing events by patients with multiple sclerosis using
Copaxone.
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Multiple
Sclerosis (MS) Drugs
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Copaxone
® Side Effects
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(glatiramer acetate)
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Adverse Events Significantly Associated
With Copaxone
®
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| The following listings are events which have been reported with
use of Copaxone ®. Events are listed within body system categories.
Unless otherwise stated, it is unknown whether the events are related
to exposure to Copaxone®.
Adverse event reporting falls
into two types:
Frequent reported
events with the use of Copaxone; and Infrequently reported
events.
To be defined as frequently
reported, an adverse event had to meet the following criteria:
Frequent adverse
events are defined as those occurring in at least 1/100 patients exposed
to Copaxone ®.
To be defined as infrequently
reported, an adverse event met the following criteria:
Infrequent adverse events are defined as those occurring
in less than 1/1000 patients exposed to Copaxone ®.
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Adverse Events Frequently Reported When Using Copaxone
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Body as a whole |
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Injection site edema, injection site atrophy, abscess, injection
site hypersensitivity. |
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Cardiovascular |
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Hypertension. |
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Gastrointestinal |
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Bowel urgency, oral moniliasis, salivary gland enlargement, tooth
caries, ulcerative stomatitis. |
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Nervous |
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Abnormal dreams, emotional lability, and stupor. |
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Respiratory |
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Hyperventilation, hay-fever. |
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Skin and appendages |
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Eczema, herpes zoster, pustular rash, skin atrophy, warts. |
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Urogenital |
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Amenorrhoea, hematuria, impotence, menorrhagia, suspicious papanicolaou
smear (pap smear), urinary frequency, vaginal haemorrhage. |
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Infrequent Adverse Events reported
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Infrequent Adverse Events Reported
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Body as a whole |
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Injection site haematoma, injection site fibrosis, moon face,
cellulitis, generalised oedema, hernia, injection site abscess,
serum sickness, suicide attempt, injection site hypertrophy, injection
site melanosis, lipoma, photosensitivity reaction. |
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Cardiovascular |
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Hypotension, midsystolic click, systolic murmur, atrial fibrillation,
bradychardia, fourth heart sound, postural hypotension, varicose
veins. |
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Digestive |
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Dry mouth, stomatitis, burning sensation on tongue, cholecystitis,
colitis, oesophageal ulcer, oesophagitis, gastrointestinal carcinoma,
gum haemorrhage, hepatomegaly, increased appetite, melena, mouth
ulceration, pancreas disorder, pancreatitis, rectal haemorrhage,
tenesmus, tongue discolouration, duodenal ulcer. |
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Endocrine |
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Goiter, hyperthyroidism, hypothyroidism. |
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Haemic and Lymphatic |
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Leukopenia, anemia, cyanosis, eosinophilia, hematemesis, lymphedema,
pancytopenia, splenomegaly. |
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Metabolic and Nutritional |
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Weight loss, alcohol intolerance, Cushing's syndrome, gout, abnormal
healing, xanthoma. |
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Musculoskeletal |
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Arthritis, muscle atrophy, bone pain, bursitis, kidney pain, muscle
disorder, myopathy, osteomyelitis, tendon pain, tenosynovitis. |
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Nervous |
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Aphasia, ataxia, convulsion, circumoral paresthesia, depersonalisation,
hallucinations, hostility, hypokinesia, coma, concentration disorder,
facial paralysis, decreased libido, manic reaction, memory impairment,
myoclonus, neuralgia, paranoid reaction, paraplegia, psychotic
depression, transient stupor. |
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Respiratory |
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Asthma, pneumonia, epistaxis, hypoventilation, voice alteration. |
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Skin and appendages |
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Dry skin, skin hypertrophy, dermatitis, furnunculosis, psoriasis,
angioedema, contact dermatitis, erythema nodosum, fungal dermatitis,
maculopapular rash, pigmentation, benign skin neoplasm, skin carcinoma,
skin striae, vesiculobullous rash. |
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Special senses |
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Dry eyes, otitis externa, ptosis, cataract, corneal ulcer, mydriasis,
optic neuritis, photophobia, taste loss. |
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Urogenital |
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Vaginitis, flank pain (kidney), abortion, breast engorgement,
breast enlargement, carcinoma in situ cervix, fibrocystic
breast, kidney calculus, nocturia, ovarian cyst, priapism, pyelonephritis,
abnormal sexual function, urethritis. |
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| Reviewed July 2004 |
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