Feldene Flash

Feldene Flash Adverse Reactions



Full Prescribing Info
Adverse Reactions
Feldene Flash is generally well tolerated. Gastrointestinal symptoms are the most commonly encountered adverse effects but in most instances do not interfere with the course of therapy. These adverse reactions include stomatitis, anorexia, epigastric distress, nausea, constipation, abdominal discomfort, flatulence, diarrhea, abdominal pain and indigestion. Gastrointestinal bleeding, perforation and ulceration (see Precautions) have been reported with Feldene Flash. Objective evaluations of gastric mucosal appearances and intestinal blood loss show that Feldene Flash 20 mg daily administered either in single or divided daily doses is significantly less irritating to the gastrointestinal tract than acetylsalicylic acid.
Long-term administration of 30-mg doses or higher carries an increased risk of gastrointestinal adverse effects.
Other than the gastrointestinal symptoms, edema, mainly of the ankle, has been reported in a small percentage of patients and the possibility of precipitating congestive cardiac failure in elderly patients or those with compromised cardiac function should therefore be borne in mind.
Central nervous system effects eg, dizziness, headache, somnolence, insomnia, depression, nervousness, hallucinations, mood alterations, dream abnormalities, mental confusion, paresthesias and vertigo have been reported rarely.
Nervous System Disorders: Aseptic meningitis, dizziness, headache, somnolence, paresthesia, vertigo, aseptic meningitis.
Swollen eyes, blurred vision and eye irritations have been reported. Routine ophthalmoscopy and slit-lamp examination have revealed no evidence of ocular changes. Malaise and tinnitus may occur.
Skin and Subcutaneous Tissue Disorders: Exfoliative dermatitis, erythema multiforme (see Precautions). Dermal hypersensitivity reactions, usually in the form of skin rash and pruritus have been reported. Onycholysis and alopecia have rarely been reported. Photoallergic reactions have infrequently been associated with therapy. As with other NSAIDs, toxic epidermal necrolysis (Lyell's disease) and Stevens-Johnson syndrome may develop in rare cases. Vesiculo bullous reactions have been reported rarely.
Hypersensitivity reactions eg, anaphylaxis, bronchospasm, urticaria/angioedema, vasculitis and "serum sickness" have been reported rarely.
Anorectal reactions to suppositories have presented as local pain, burning, pruritus and tenesmus. Rare instances of rectal bleeding have occurred.
Reversible elevations of BUN and creatinine have been reported.
Decreases in hemoglobin and hematocrit, unassociated with obvious GI bleeding, have occurred. Anemia has been reported. Thrombocytopenia and nonthrombocytopenic purpura (Henoch-Schoenlein), leucopenia and eosinophilia have been reported. Rare cases of aplastic and hemolytic anemia. Epistaxis has rarely been reported.
Changes in different liver function parameters have been observed. As with most other NSAIDs, some patients may develop increased serum transaminase levels during treatment with Feldene Flash. Severe hepatic reactions, including jaundice and cases of fatal hepatitis have been reported. Although such reactions are rare, if abnormal liver function tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop or if systemic manifestations occur (eg, eosinophilia, rash, etc), Feldene Flash should be discontinued.
Rare cases of pancreatitis have been reported.
Palpitations and dyspnea have been reported rarely.
Anecdotal cases of positive ANA and of hearing impairment have been reported rarely in patients receiving Feldene Flash.
Metabolic abnormalities eg, hypoglycemia, hyperglycemia, increased or decreased weight have been reported rarely.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in