Jaw Osteonecrosis on Bone Medicines: Label Facts
[Answers · Bone, menopause and fertility medicines]

Can bone medicines like Fosamax or Prolia cause jaw problems?

From FDA labels, public health agencies and published studies · Reviewed

Short answer: Rarely, yes. Osteonecrosis of the jaw (ONJ), a serious jaw bone problem, is a warning on the Fosamax, Actonel, Reclast, Prolia and Evenity labels. The labels say it is usually linked to a tooth extraction or a local infection with slow healing, can happen on its own, and may become more likely the longer the medicine is used. They ask for a mouth check before starting and good mouth care during.

What the labels say

The Fosamax label (section 5.4) says ONJ can occur spontaneously, is generally associated with tooth extraction and/or local infection with delayed healing, and has been reported in people taking bisphosphonates. The Prolia label (section 5.4) uses the same description for denosumab, and the Actonel, Reclast and Evenity labels carry an ONJ warning as well (section 5.4 in each).

The Fosamax and Prolia labels say the risk of ONJ may increase with the duration of exposure. None of these sections gives a single rate that applies to everyone.

Risk factors the labels name

  • Invasive dental procedures, such as tooth extraction, dental implants or bone surgery
  • A diagnosis of cancer
  • Other treatments: chemotherapy, corticosteroids, angiogenesis inhibitors
  • Poor oral hygiene
  • Other conditions: gum disease or other dental disease, anemia, clotting problems, infection, ill-fitting dentures

The list is the same in the Fosamax and Prolia labels. The Prolia label adds that taking other drugs linked to ONJ at the same time may increase the risk.

Dental care before and during treatment

The Prolia label says the prescriber should do a routine oral exam before starting, and recommends a dental exam with preventive dentistry first for people with the risk factors above. It says good oral hygiene should be kept up during treatment. The Fosamax and Prolia Medication Guides tell patients that the doctor should examine their mouth before they start, may send them to a dentist first, and that good mouth care during treatment is important.

For people who need invasive dental work, the Fosamax label says stopping the bisphosphonate may reduce the risk of ONJ, and both labels say the judgment of the treating physician and/or oral surgeon should guide the plan for each person. That is a joint decision between your prescriber and dentist, not one to make alone.

If ONJ happens

The Fosamax label says people who develop ONJ on a bisphosphonate should be cared for by an oral surgeon, that extensive dental surgery may make it worse, and that stopping the medicine should be considered case by case. The Evenity label summary says to monitor for symptoms and consider stopping based on benefit and risk.

Before a dental appointment it helps to have the name of your bone medicine, when you started, and the date of your last dose or infusion. Dose Track keeps that history, and the Prolia and Fosamax side effect pages list the rest of each label's warnings.

Read more on Dose Track: Fosamax side effects · Prolia side effects · Evenity side effects · Reclast side effects

General education drawn from labels, public health agencies and published studies, not personal medical advice. Your prescriber, pharmacist and the label that came with your medicine are the final word. Questions for other users? Ask in the Dose Track community.

Frequently asked questions

What is osteonecrosis of the jaw?+
A serious jaw bone problem that the Medication Guides call severe jaw bone problems. The labels say it is usually linked to a tooth extraction or local infection with delayed healing.
Should I tell my dentist I take Prolia or Fosamax?+
Yes. The Medication Guides say your doctor may send you to a dentist before you start, and the labels say dental work plans should be guided by your physician and oral surgeon together.
Does ONJ risk go up the longer I take it?+
The Fosamax and Prolia labels say the risk may increase with duration of exposure.
Should I stop my bone medicine before dental work?+
The Fosamax label says stopping may reduce the risk for invasive dental procedures, but that the treating physician and oral surgeon should decide case by case. Ask both before changing anything.