Note: This document contains side effect information about calcitonin. Some dosage forms listed on this page may not apply to the brand name Fortical.

Applies to calcitonin: injection solution. Other dosage forms:

• nasal spray

Serious side effects of Fortical

Along with its needed effects, calcitonin (the active ingredient contained in Fortical) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking calcitonin:

Incidence not known

• Blurred vision
• chills or fever
• cough
• difficulty with breathing
• difficulty with swallowing
• dizziness
• frequent urination
• headache
• joint pain
• muscle aches and pains
• muscle cramps in the hands, arms, feet, legs, or face
• nausea or vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seizures
• skin rash or itching
• slow or fast heartbeat
• sweating
• swelling of the hands, ankles, feet, or lower legs
• tightness in the chest
• tingling of the hands or feet
• trembling or shaking of the legs, arms, hands or feet
• trouble sleeping
• unusual tiredness or weakness
• unusual weight gain or loss

Other side effects of Fortical

Some side effects of calcitonin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Red streaks on the skin
• swelling, tenderness, or pain at the injection site

Less common

• Feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest

Incidence not known

• Abdominal or stomach pain
• changes in vision
• diarrhea
• pain in the eyes
• poor appetite
• waking to urinate at night

For Healthcare Professionals

Applies to calcitonin: injectable solution, nasal spray.

General

The most commonly reported adverse effects with use of the injection are nausea, injection site inflammation, and flushing of face or hands; rhinitis, epistaxis, back pain, arthralgia, and headache have been reported with use of the nasal spray.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (10%)

Common (1% to 10%): Abdominal pain

Frequency not reported: Salty taste, diarrhea

With parenteral use, nausea with or without vomiting appears most frequently upon treatment initiation and tends to decrease or disappear with continued use.

Local

Very common (10% or more): Inflammatory reactions at the site of injection

Metabolic

Frequency not reported: Poor appetite

Postmarketing reports: Hypocalcemia with tetany (muscle cramps, twitching) and seizure activity

Hypersensitivity

Postmarketing reports: Serious hypersensitivity reactions including bronchospasm, swelling of the tongue or throat, anaphylactic shock, and death due to anaphylaxis

Respiratory

Symptoms of nose include: Nasal crusts, dryness, redness or erythema, nasal sores, irritation, itching, thick feeling, soreness, pallor, infection, stenosis, runny/blocked, small wound, bleeding wound, tenderness, uncomfortable feeling, and sore across bridge of nose.^[Ref]

Very common (10% or more): Rhinitis (12%), symptoms of nose (11%)

Common (1% to 10%): Epistaxis, sinusitis, upper respiratory tract infection, bronchospasm

Postmarketing reports: Cough, dyspnea^[Ref]

Cardiovascular

Frequency not reported: Pedal edema

Postmarketing reports: Edema (facial, peripheral, and generalized), hypertension, chest pain syncope, vasodilation

Nervous system

Common (1% to 10%): Dizziness, paresthesia

Postmarketing reports: Headache, tremor, seizure, loss of taste/smell

Immunologic

Postmarketing reports: Anti-drug antibodies

For those that antibody studies were done, circulating antibodies to calcitonin were found in about 50% of patients with Paget's disease after 2 to 18 months of treatment. Circulating antibodies have also been reported with use of the nasal spray.

Dermatologic

Common (1% to 10%): Flushing of hand or face, erythematous rash

Frequency not reported: Skin rashes and pruritus of ear lobes

Postmarketing reports: Urticaria, rash/dermatitis, pruritus, alopecia, increased sweating

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, arthrosis, myalgia

Postmarketing reports: Musculoskeletal pain^[Ref]

Hematologic

Common (1% to 10%): Lymphadenopathy

Ocular

Common (1% to 10%): Abnormal lacrimation, conjunctivitis

Frequency not reported: Eye pain

Postmarketing reports: Visual disturbance, visual or hearing impairment, tinnitus

Psychiatric

Common (1% to 10%): Depression

Genitourinary

Frequency not reported: Nocturia

Postmarketing reports: Polyuria

Oncologic

Common (1% to 10%): Malignancy

A meta-analysis of 21 randomized, controlled clinical trials among patients using the nasal spray or an investigational oral formulation found the overall incidence of malignancy in patients receiving this drug was 4.1% (254/6151) compared to 2.9% (137/4732) in placebo. An analyses of just nasal spray trials showed the incidence was similar (4.5% vs 2.3%). Data has shown the increased risk was heavily influenced by a single large 5-year trial. A mechanism for this increased risk has not been identified.

Other

Common (1% to 10%): Influenza-like symptoms

Frequency not reported: Feverish sensation

Postmarketing reports: Fatigue