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Potential Side Effects of FORTEO
When taking FORTEO, you may experience side effects. It's important to talk to your doctor if you have concerns about side effects.
What Is the Most Important Information I Should Know About FORTEO?
WARNING: POTENTIAL RISK OF OSTEOSARCOMA
During the drug testing process, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. In people, osteosarcoma is a serious but rare cancer.
Osteosarcoma has been reported rarely in people who took FORTEO. It is not known if people who take FORTEO have a higher chance of getting osteosarcoma. Before you take FORTEO,
you should tell your healthcare provider if you have Paget's disease of bone, are a child or young adult whose bones are still growing, or have had radiation therapy.
- You should not take FORTEO for more than 2 years over your lifetime.
Who Should Not Use FORTEO?
Do not use FORTEO if you:
- are allergic to any of the ingredients in FORTEO (see the Medication Guide for a complete list of the ingredients in FORTEO).
What Should I Tell My Healthcare Provider Before Taking FORTEO?
Before you take FORTEO, tell your healthcare provider if you:
- have the condition listed in the section above "Who Should Not Use FORTEO?".
- have Paget's disease or other bone disease.
- have cancer in your bones.
- have trouble injecting yourself and do not have someone who can help you.
- are a child or young adult whose bones are still growing.
- have or have had kidney stones.
- have had radiation therapy.
- have or had too much calcium in your blood.
- have any other medical conditions.
- are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if FORTEO passes into your breast milk. You and your doctor should decide if you will take FORTEO or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Your healthcare provider needs this information to help keep you from taking FORTEO with other medicines that may harm you.
- Especially tell your doctor if you take medicines that contain digoxin (Digoxin*, Lanoxicaps*, Lanoxin*).
Be sure to be completely open with your doctors about any medical conditions you have, so they can make sure FORTEO is appropriate for you.
*The brands listed are trademarks of their respective owners and are not trademarks of Eli Lilly and Company.
Other Serious Side Effects
- A decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses.
This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, take your injections of FORTEO in a place
where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider.
- Increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness.
These may be signs there is too much calcium in your blood.
Common Side Effects of FORTEO
- Nausea
- Joint aches
- Pain
- Leg cramps
- Injection site reactions such as swelling, pain, and bruising
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of FORTEO.
For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA. Visit or call 1-800-FDA-1088.
Are You Caring for Someone on FORTEO?
If FORTEO has been recommended to someone you're caring for, encourage them to discuss the potential side effects of FORTEO treatment with their healthcare provider.
While it is ultimately the patient's choice whether or not to begin FORTEO, you can help your patient or loved one make an informed
decision by learning the facts about FORTEO.
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Indications for FORTEO:
- FORTEO is used in both men and postmenopausal women with osteoporosis who are at high risk for having broken bones or fractures.
- FORTEO is used in both men and women with osteoporosis due to use of glucocorticoid medicines, such as prednisone, for several months, who are at high risk for having broken bones or fractures.
- FORTEO can be used by people who have had a fracture related to osteoporosis, or who have several risk factors for fracture, or who cannot use other osteoporosis treatments.
FORTEO is a prescription medicine given as a 20-microgram once-daily dose available in a 2.4-mL delivery device for subcutaneous injection over 28 days.
Important Safety Information About FORTEO
What is the most important information I should know about FORTEO?
WARNING: POTENTIAL RISK OF OSTEOSARCOMA
During the drug testing process, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma.
In people, osteosarcoma is a serious but rare cancer. Osteosarcoma has been reported rarely in people who took FORTEO. It is not known if people who take FORTEO have
a higher chance of getting osteosarcoma. Before you take FORTEO, you should tell your healthcare provider if you have Paget's disease of bone, are a child or young adult
whose bones are still growing, or have had radiation therapy.
Who should not take FORTEO?
- You should not take FORTEO for more than 2 years over your lifetime.
- Do not use FORTEO if you are allergic to any of the ingredients in FORTEO. Serious allergic reactions have been reported.
What should I tell my healthcare provider before taking FORTEO?
- Before you take FORTEO, you should tell your healthcare provider if you have a bone disease other than osteoporosis, have cancer in your bones, have trouble injecting yourself and do not have someone who can help you, have or have had kidney stones, have or have had too much calcium in your blood, take medications that contain digoxin (Digoxin, Lanoxicaps, Lanoxin), or have any other medical conditions.
- You should also tell your healthcare provider, before you take FORTEO, if you are pregnant or thinking about becoming pregnant. It is not known if FORTEO will harm your unborn baby. If you are breastfeeding or plan to breastfeed, it is not known if FORTEO passes into your breast milk. You and your healthcare provider should decide if you will take FORTEO or breastfeed. You should not do both.
What are the possible side effects of FORTEO?
- FORTEO can cause serious side effects including a decrease in blood pressure when you change positions. Some people feel dizzy, get a fast heartbeat, or feel faint right after the first few doses. This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, take your injections of FORTEO in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking FORTEO and call your healthcare provider. FORTEO may also cause increased calcium in your blood. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
- Common side effects of FORTEO include nausea, joint aches, pain, leg cramps, and injection site reactions including injection site pain, swelling and bruising. These are not all the possible side effects of FORTEO. You are encouraged to report negative side effects of Prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
Additional safety information about FORTEO
- There is a voluntary patient registry for people who take FORTEO. The purpose of the registry is to collect information about the possible risk of osteosarcoma in people who take FORTEO. For information about how to sign up for this patient registry, call 1-866-382-6813 or go to .
- The FORTEO Delivery Device has enough medicine for 28 days. It is set to give a 20-microgram dose of medicine each day. Before you try to inject FORTEO yourself, a healthcare provider should teach you how to use the FORTEO Delivery Device to give your injection the right way. Inject FORTEO one time each day in your thigh or abdomen (lower stomach area). Do not inject all the medicine in the FORTEO Delivery Device at any one time. Do not transfer the medicine from the FORTEO Delivery Device to a syringe. This can result in taking the wrong dose of FORTEO. If you take more FORTEO than prescribed, call your healthcare provider. If you take too much FORTEO, you may have nausea, vomiting, weakness, or dizziness.
How should I store FORTEO?
- Keep your FORTEO Delivery Device in the refrigerator between 36°F to 46°F (2°C to 8°C). Do not freeze the FORTEO Delivery Device. Do not use FORTEO if it has been frozen. Do not use FORTEO after the expiration date printed on the delivery device and packaging. Throw away the FORTEO Delivery Device after 28 days even if it has medicine in it (see the User Manual).
For more safety information, please see Medication Guide and Full Prescribing Information, including Boxed Warning
regarding osteosarcoma.
See Full Delivery Device User Manual that accompanies the Delivery Device.
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