Skelan Forte Adverse Reactions

Naproxen sodium: The most commonly reported adverse reactions associated with naproxen sodium are gastrointestinal (e.g., heartburn, constipation, abdominal pain, nausea), of which peptic ulcer, with or without bleeding, is the most severe. Headache, dizziness, drowsiness, pruritus, ecchymoses, skin eruptions, and tinnitus are also frequently reported.
Infections and infestations: Infections, sepsis.
Blood and lymphatic system disorders: Agranulocytosis, anemia, aplastic anemia, coagulopathy, eosinophilia, granulocytopenia, hemolytic anemia, immune thrombocytopenic purpura, leukopenia, lymphadenopathy, pancytopenia, thrombocytopenia.
Immune system disorders: Anaphylactic reaction, anaphylactoid reaction, angioneurotic edema, bronchospasm, systemic lupus erythematosus.
Metabolism and nutrition disorders: Anorexia, changes in appetite, decreased appetite, edema, fluid retention, hyperglycemia, hyperkalemia, hypoglycemia, peripheral edema.
Psychiatric disorders: Abnormal dreams, anxiety, confusion, depression, disorientation, disturbance in attention, euphoria, hallucinations, insomnia, sleep disorders, somnolence.
Nervous system disorders: Aseptic meningitis, ataxia, cognitive dysfunction (e.g., difficulty in calculations), coma, convulsion, dizziness, dysarthria, exacerbation of Parkinson's disease, lightheadedness, loss of short-term memory, myasthenia, nervousness, paresthesia, peripheral neuropathy, seizures, tremor, vertigo.
Eye disorders: Blurred vision, conjunctivitis, corneal opacity, exacerbation of glaucoma, keratopathy, papilledema, papillitis, retrobulbar optic neuritis, visual impairment.
Ear and labyrinth disorders: Hearing disturbances, hearing impairment.
Cardiac disorders: Arrhythmia, cardiac failure, chest discomfort, chest pain, congestive heart failure, myocardial infarction, palpitations, tachycardia.
Vascular disorders: Cerebrovascular accident, hypersensitivity vasculitis, hypertension, hypotension, stroke, syncope, vasculitis, worsening of hypertension.
Respiratory, thoracic, and mediastinal disorders: Aggravated asthma, asthma, dyspnea, eosinophilic pneumonia, pneumonia, pulmonary edema, respiratory depression, rhinorrhea, wheezing.
Gastrointestinal disorders: Abdominal discomfort, aggravated Crohn's disease, aggravated ulcerative colitis, aphthous stomatitis, colitis, diarrhea, diverticulitis, dry mouth, dyspepsia, eosinophilic colitis, epigastric distress, eructation, esophageal ulcer, esophagitis, flatulence, gastritis, gastrointestinal hemorrhage, gastrointestinal inflammation, gastrointestinal obstruction, gastrointestinal perforation, gastrointestinal ulceration (gastric/duodenal/nonpeptic), glossitis, hematemesis, melena, oropharyngeal pain, pancreatitis, peptic ulcerations (with or without bleeding), rectal hemorrhage, salivary gland enlargement, stomatitis, throat irritation, ulcerative stomatitis, vomiting.
Hepatic and hepatobiliary disorder: Cholestatic jaundice, cholestasis, fulminant hepatitis, hepatic cirrhosis, hepatitis, jaundice, liver failure.
Skin and subcutaneous tissue disorders: Alopecia, blister, bullous dermatitis, epidermolysis bullosa, epidermal necrolysis, erythema multiforme, erythema nodosum, exfoliative dermatitis, facial scars, fixed drug eruption, lichen planus, photodermatosis, photosensitive dermatitis, photosensitivity reaction, pseudoporphyria, purpura, pustular reaction, rash, skin fragility, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Musculoskeletal and connective tissue disorders: Muscle spasms, muscle weakness, musculoskeletal stiffness, myalgia, stiff neck.
Renal and urinary disorders: Acute renal failure, cystitis, dysuria, glomerular nephritis, hematuria, interstitial nephritis, nephritic syndrome, nephritis, nephrotic syndrome, nephropathy, oliguria, pollakiuria, polyuria, proteinuria, renal disease, renal failure, renal insufficiency, renal papillary necrosis, renal tubular necrosis.
Reproductive system and breast disorders: Infertility [female], menstrual disorder.
General disorders and administration site conditions: Asthenia, chills, death, fatigue, fever, hypothermia, irritability, malaise, pyrexia, sweating, thirst, weakness.
Investigations: Abnormal liver function tests, abnormal renal function, changes in weight (i.e., weight gain), decreased creatinine clearance, elevated liver enzymes, increased alkaline phosphatase (ALP), increased blood pressure, increased blood urea nitrogen, increased bilirubin levels, increased serum creatinine, prolonged bleeding times.
Paracetamol: Paracetamol, when taken within the recommended dose and duration of treatment, has low incidence of side effects. The most common side effects are constipation, headache, insomnia, nausea, and vomiting.
Infections and infestations: Infections.
Blood and lymphatic system disorders: Agranulocytosis, anemia, leukopenia, methemoglobinemia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura.
Immune system disorders: Angioedema, anaphylactoid reactions, anaphylaxis, asthma, bronchospasm, laryngeal edema, periorbital edema, swelling of the face, mouth, and throat.
Metabolism and nutrition disorders: Anorexia, hyperammonemia, hyperchloremia, hyperuricemia, metabolic acidosis, pyroglutamic aciduria, sudden weight loss.
Ear and labyrinth disorders: Hearing loss.
Vascular disorders: Hemorrhage, hypertension, hypotension.
Respiratory, thoracic and mediastinal disorders: Dyspnea, respiratory distress, rhinorrhea, wheezing.
Gastrointestinal disorders: Gastrointestinal disturbances, mouth ulceration.
Hepatobiliary disorders: Acute liver failure, hepatic dysfunction, hepatotoxicity, jaundice.
Skin and subcutaneous tissue disorder: Acute generalized exanthematous pustulosis, blister, contusion, erythema, pruritus, rash (pruritic maculopapular), skin exfoliation, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.
Renal and urinary disorders: Nephropathy.
Investigations: Decreased serum bicarbonate, decreased serum calcium, decreased serum sodium, increased alanine aminotransferase, increased aspartate aminotransferase (AST), increased serum glucose.