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Alendronic acid oral 10mg


Oral formulation of low strength alendronic acid (10mg).

Drugs List

  • alendronic acid 10mg tablets
  • Therapeutic Indications


    Prophylaxis and treatment of glucocorticoid induced osteoporosis
    Treatment of osteoporosis in men to prevent fractures
    Treatment of osteoporosis in postmenopausal women to prevent fractures



    10mg once daily.


    Children under 18 years
    Inability to stand or sit upright for at least 30 minutes
    Delayed oesophageal emptying
    Oesophageal obstruction
    Oesophageal strictures
    Renal impairment - glomerular filtration rate below 35ml/minute

    Precautions and Warnings

    Gastrointestinal haemorrhage
    Glucose-galactose malabsorption syndrome
    History of gastrointestinal ulceration
    Lactose intolerance
    Peptic ulcer
    Upper gastrointestinal surgery
    Vitamin D deficiency

    Calcium supplements may be required if risk of calcium/vitamin D deficiency
    Consider a dental exam & appropriate preventive dentistry before treatment
    Consider other causes of osteoporosis
    Contains lactose
    Patient must remain upright for at least 30 minutes after dose
    Correct disturbances of calcium and mineral metabolism before initiation
    Dental check-ups advisable during long-term treatment
    Ensure patient's dietary intake of calcium and vitamin D is adequate
    Evaluate benefit/risk in long term use ( > 5 years)
    Monitor serum calcium levels
    Advise patient to report any ear pain, discharge or infection
    Advise patient to report any new thigh, hip or groin pain
    Patients should seek medical attention upon signs of oesophageal irritation
    Consider discontinuation if atypical femoral fracture occurs
    Discontinue if symptoms of oesophageal irritation occur
    Advise patients to avoid aspirin and NSAID use
    Advise patient of need for high oral hygiene standards
    Advise patient to follow dosage instructions closely
    Advise patient to report any dental mobility, pain or swelling
    Patient to inform dentist of bisphosphonate use: avoid invasive procedures

    Severe oesophageal reactions (oesophagitis, oesophageal ulcers, oesophageal stricture and oesophageal erosions) have been reported. Physicians should be alert to the possibility of such reactions developing and patients should be advised to discontinue treatment and seek medical attention if they develop signs of oesophageal irritation such as dysphagia, pain on swallowing, retrosternal pain or new or worsening heartburn.

    Atypical stress fractures of the proximal femoral shaft with poor healing have been reported in patients treated with alendronic acid, mainly in patients receiving long term treatment for osteoporosis.

    Osteonecrosis of the jaw has been reported in cancer patients taking bisphosphonate regimens often with concurrent chemotherapy and corticosteroids. These cases have mainly been associated with dental procedures such as tooth extraction and many have shown signs of local infection including osteomyelitis. There is no data available to suggest discontinuation of bisphosphonate treatment prior to dentistry reduces the risk of osteonecrosis of the jaw.

    Osteonecrosis of the external auditory canal has been reported very rarely with bisphosphonates, mainly in association with long term therapy (2 years or longer). Risk factors include steroid use and chemotherapy and/or local risk factors as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.

    Patients should be re-evaluated periodically based on an assessment of the benefits and risks of the bisphosphonate treatment, especially after 5 years or more of treatment.

    Pregnancy and Lactation


    Alendronic acid is contraindicated during pregnancy.

    The manufacturer does not recommend using alendronic acid during pregnancy. Animal studies have shown reproduction toxicological effects and although the significance to humans is unknown, alendronic acid should not be used in human pregnancy. If treatment has been discontinued before pregnancy, the very long elimination half life from bone indicates that women treated with alendronic acid will have detectable concentrations of the drug for a prolonged interval (Briggs, 2015). Schaeffer (2015) states that accidental use of a single dose does not justify interruption of the pregnancy or additional diagnostic procedures.


    Alendronic acid is contraindicated during breastfeeding.

    The manufacturer does not recommend breastfeeding whilst taking alendronic acid. It is not known whether alendronic acid passes to human milk. However, the extremely low oral bioavailability of bisphosphonates in the non-fasting state implies that systemic levels in the nursing infant should be negligible. A risk to the neonate cannot be excluded.


    Advise patients that the tablet should be swallowed whole and not sucked or chewed.

    Advise patients that the tablets should be taken 30 minutes before the first food, beverage or medication of the day, washed down with a full glass of plain (not mineral) water only.

    Also advise patients that they should remain upright for at least 30 minutes after dose and until after first food of the day. They should not take the tablets at bedtime or before rising for the day.

    Inform patients that failure to follow these instructions may increase their risk of oesophageal problems.

    Patients should be counselled to discontinue treatment and seek medical attention if they develop signs of oesophageal irritation (dysphagia, new or worsening heartburn, pain on swallowing or retrosternal pain).

    Advise patients to inform their dentist that they are taking bisphosphonates and should not undergo invasive dental procedures.

    Advise patients to maintain adequate oral hygiene during and after treatment with bisphosphonates. Patients should report any oral symptoms such as dental mobility, pain or swelling.

    Advise patients to report any new thigh, hip or groin pain during treatment with alendronic acid.

    Advise patients not to self medicate with aspirin or ibuprofen.

    Advise patient to report any ear pain, discharge or infection.

    Side Effects

    Abdominal distension
    Abdominal pain
    Acid regurgitation
    Atypical femoral fracture
    Bone pain
    Decrease in plasma calcium
    Decrease in serum phosphate
    Gastro-intestinal perforation
    Gastro-intestinal ulceration
    Gastrointestinal bleeding
    Hypersensitivity reactions
    Hypocalcaemia (symptomatic)
    Joint pain
    Joint swelling
    Musculoskeletal pain
    Oesophageal erosions
    Oesophageal stricture
    Oesophageal ulceration
    Oropharyngeal ulceration
    Osteonecrosis (primarily of the jaw)
    Osteonecrosis of the external auditory canal
    Peripheral oedema
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: November 2021

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Alendronic Acid 10mg Tablets. Accord Healthcare Ltd. Revised March 2017.

    MHRA Drug Safety Update November 2009
    Available at:
    Last accessed: 17 November 2021

    MHRA Drug Safety Update December 2011
    Available at:
    Last accessed: 17 November 2021

    MHRA Drug Safety Update December 2015
    Available at:
    Last accessed: 17 November 2021

    NICE - Evidence Services
    Available at:
    Last accessed: 17 November 2021

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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