Calcitonin-Salmon Nasal Spray Side Effects

Please note - some side effects for Calcitonin-Salmon Nasal Spray may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Calcitonin-Salmon Nasal Spray Side Effects - for the Professional

Calcitonin-Salmon Nasal Spray

The incidence of adverse reactions reported in studies involving postmenopausal osteoporotic patients chronically exposed to Calcitonin-Salmon Nasal Spray (N=341) and to placebo nasal spray (N=131) and reported in greater than 3% of Calcitonin-Salmon Nasal Spray treated patients are presented below in the following table. Most adverse reactions were mild to moderate in severity. Nasal adverse events were most common with 70% mild, 25% moderate, and 5% severe in nature (placebo rates were 71% mild, 27% moderate, and 2% severe).

In addition, the following adverse events were reported in fewer than 3% of patients during chronic therapy with Calcitonin-Salmon Nasal Spray. Adverse events reported in 1%-3% of patients are identified with an asterisk(*). The remainder occurred in less than 1% of patients. Other than flushing, nausea, possible allergic reactions, and possible local irritative effects in the respiratory tract, a relationship to Calcitonin-Salmon Nasal Spray has not been established.

Body as a whole – General Disorders: influenza-like symptoms*, fatigue*, periorbital edema, fever

Integumentary:erythematous rash*, skin ulceration, eczema, alopecia, pruritus, increased sweating

Musculoskeletal/Collagen:arthrosis*, myalgia*, arthritis, polymyalgia rheumatica, stiffness

Respiratory/Special Senses:sinusitis*, upper respiratory tract infection*, bronchospasm*, pharyngitis, bronchitis, pneumonia, coughing, dyspnea, taste perversion, parosmia

Cardiovascular:hypertension*, angina pectoris*, tachycardia, palpitation, bundle branch block, myocardial infarction

Gastrointestinal:dyspepsia*, constipation*, abdominal pain*, nausea*, diarrhea*, vomiting, flatulence, increased appetite, gastritis, dry mouth

Liver/Metabolic:cholelithiasis, hepatitis, thirst, weight increase

Endocrine:goiter, hyperthyroidism

Urinary System:cystitis*, pyelonephritis, hematuria, renal calculus

Central and Peripheral Nervous System:dizziness*, paresthesia*, vertigo, migraine, neuralgia, agitation

Hearing/Vestibular:tinnitus, hearing loss, earache

Vision:abnormal lacrimation*, conjunctivitis*, blurred vision, vitreous floater

Vascular:flushing, cerebrovascular accident, thrombophlebitis

Hematologic/Resistance Mechanisms:lymphadenopathy*, infection*, anemia

Psychiatric:depression*, insomnia, anxiety, anorexia

Common adverse reactions associated with the use of injectable calcitonin-salmon occurred less frequently in patients treated with Calcitonin-Salmon Nasal Spray than in those patients treated with injectable calcitonin. Nausea, with or without vomiting, which occurred in 1.8% of patients treated with the nasal spray (and 1.5% of those receiving placebo nasal spray) occurs in about 10% of patients who take injectable calcitonin-salmon. Flushing, which occurred in less than 1% of patients treated with the Nasal Spray, occurs in 2%-5% of patients treated with injectable calcitonin-salmon. Although the administered dosages of injectable and nasal spray calcitonin-salmon are comparable (50-100 units daily of injectable versus 200 units daily of nasal spray), the nasal dosage form has a mean bioavailability of about 3% (range 0.3%-30.6%) and therefore provides less drug to the systemic circulation, possibly accounting for the decrease in frequency of adverse reactions.

The collective foreign marketing experience with Calcitonin-Salmon Nasal Spray does not show evidence of any notable difference in the incidence profile of reported adverse reactions when compared with that seen in the clinical trials.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.