Risaldene Side effects

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Side effects of Risaldene in details

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More than 10%: Cardiovascular: Hypertension (11%).

Central Nervous System: Headache (3-18%).

Dermatologic: Rash (8-12%).

Endocrine and Metabolic: Increased serum parathyroid hormone (PTH) levels (<30%).

Gastrointestinal: Diarrhea (5-20%); nausea (4-13%); constipation (3-13%); abdominal pain (2-12%); dyspepsia (4-11%).

Genitourinary: Urinary tract infection (11%).

Neuromuscular and Skeletal: Arthralgia (7-33%); back pain (6-28%).

Miscellaneous: Infection (≤31%).

1-10%: Cardiovascular: Peripheral edema (8%); chest pain (5-7%); arrhythmia (2%).

Central Nervous System: Depression (7%); dizziness (3-7%).

Endocrine and Metabolic: Hypocalcemia (≤5%); hypophosphatemia (<3%).

Gastrointestinal: Vomiting (2-5%); gastritis (3%); duodenitis (≤1%); glossitis (≤1%).

Genitourinary: Prostatic hyperplasia (5%); nephrolithiasis (3%).

Neuromuscular and Skeletal: Joint disorder (7%); myalgia (2-7%); neck pain (5%); muscle spasm (1-2%).

Ocular: Cataract (7%).

Respiratory: Bronchitis (3-10%); pharyngitis (6%); rhinitis (6%); dyspnea (4%).

Miscellaneous: Flu-like syndrome (10%); acute phase reaction (includes fever, influenza-like illness) (≤8%).

Less than 1%: Limited to Important or Life-Threatening: Diaphyseal femur fracture, dysphagia, esophageal cancer, esophageal ulcer, esophagitis, gastric ulcer, hypersensitivity reaction, musculoskeletal pain (rarely severe or incapacitating), osteonecrosis (primarily of the jaw), subtrochanteric femur fracture (<1%).

Risaldene contraindications

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Hypersensitivity to risedronate sodium or to any of the excipients of Risaldene. Hypocalcaemia.

Use in pregnancy & lactation: There are no adequate data from the use of risedronate sodium in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Studies in animal indicate that a small amount of risedronate sodium pass into breast milk. Risedronate sodium must not be used during pregnancy or by breastfeeding women.

Severe renal impairment (CrCl <30 mL/min).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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