ADVERSE REACTIONS
Special Senses: Ocular: Irreversible retinal damage in patients receiving long-term or high-dosage 4-aminoquinoline therapy; visual disturbances (blurring of vision and difficulty of focusing or accommodation); nyctalopia; scotomatous vision with field defects of paracentral, pericentral ring types, and typically temporal scotomas, e.g., difficulty in reading with words tending to disappear, seeing half an object, misty vision, and fog before the eyes. Reversible corneal opacities have also been reported.
Auditory: Nerve type deafness; tinnitus, reduced hearing in patients with preexisting auditory damage.
Musculoskeletal system: Skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, which may be associated with mild sensory changes, depression of tendon reflexes and abnormal nerve conduction, have been noted.
Gastrointestinal system: Hepatitis, increased liver enzymes, anorexia, nausea, vomiting, diarrhea, abdominal cramps.
Skin and appendages: Rare reports of erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and similar desquamation-type events. Pleomorphic skin eruptions, skin and mucosal pigmentary changes; lichen planus-like eruptions, pruritus, urticaria, anaphylactic/anaphylactoid reaction including angioedema, photosensitivity and hair loss and bleaching of hair pigment.
Hematologic system: Rarely, pancytopenia, aplastic anemia, reversible agranulocytosis, thrombocytopenia and neutropenia.
Nervous system: Convulsive seizures, mild and transient headache, polyneuritis. Neuropsychiatric changes including psychosis, delirium, anxiety, agitation, insomnia, confusion, hallucinations, personality changes, and depression.
Cardiovascular system: Rarely, hypotension, electrocardiographic change (particularly, inversion or depression of the T-wave with widening of the QRS complex), and cardiomyopathy.
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REPORTS OF SUSPECTED ARALEN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Aralen. The information is not vetted and should not be considered as verified clinical evidence.
Possible Aralen side effects / adverse reactions in 53 year old female
Reported by a consumer/non-health professional from Mexico on 2012-03-23
Patient: 53 year old female weighing 71.0 kg (156.2 pounds)
Reactions: Cataract, Anaemia, Vision Blurred
Adverse event resulted in: disablity
Suspect drug(s):
Deflazacort
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2007-01-01
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Aralen
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Possible Aralen side effects / adverse reactions in 53 year old female
Reported by a consumer/non-health professional from Mexico on 2012-04-11
Patient: 53 year old female weighing 71.0 kg (156.2 pounds)
Reactions: Cataract, Anaemia, Vision Blurred
Adverse event resulted in: disablity
Suspect drug(s):
Aralen
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Deflazacort
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Arava
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2008-01-01
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
Start date: 2007-01-01
Possible Aralen side effects / adverse reactions in 53 year old female
Reported by a consumer/non-health professional from Mexico on 2012-06-29
Patient: 53 year old female weighing 75.0 kg (165.0 pounds)
Reactions: Type 2 Diabetes Mellitus
Suspect drug(s):
Aralen
Other drugs received by patient: Methotrexate
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