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SAFETY SUMMARY

Warnings - FORTEO may cause serious side effects, including:

Allergic (hypersensitivity) reactions, including anaphylaxis. Stop using FORTEO and get medical help right away if you have any of the following symptoms of an allergic reaction:

  • swelling of your face, lips, mouth, or tongue
  • breathing problems
  • fainting, dizziness, feeling lightheaded (low blood pressure)
  • fast heartbeat
  • itching
  • rash
  • hives

Do not use FORTEO if you have had a severe allergic reaction to teriparatide or any of the ingredients in FORTEO. Ask your healthcare provider if you are not sure.

Possible bone cancer (osteosarcoma): During drug testing, the medicine in FORTEO caused some rats to develop a bone cancer called osteosarcoma. Studies in people have not shown that FORTEO increases your chance of getting osteosarcoma. There is little information about the chance of getting osteosarcoma in patients using FORTEO beyond 2 years. Tell your healthcare provider right away if you have pain in your bones, pain in any areas of your body that does not go away, or any new or unusual lumps or swelling under your skin that is tender to touch.

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.

Worsening of your kidney stones: If you have or have had kidney stones, your healthcare provider may check the calcium levels in your urine while you use FORTEO to see if there is worsening of this condition.

Decrease in blood pressure when you change positions: Some people may feel dizzy, get a fast heartbeat, or feel light-headed right after the first few doses of FORTEO. This usually happens within 4 hours of taking FORTEO and goes away within a few hours. For the first few doses, give 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, contact your healthcare provider before you continue using FORTEO.

Common side effects

  • pain
  • nausea
  • joint aches

Tell your doctor if you have any side effects. These are not all the possible side effects of FORTEO. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch .

Before using

Before you use FORTEO, tell your healthcare provider about all of your medical conditions, including if you:

  • have a certain bone disease called Paget’s disease or other bone disease, have bone cancer or have had a history of bone cancer
  • are a young adult whose bones are still growing
  • have had radiation therapy
  • are affected with a condition that runs in your family that can increase your chance of getting cancer in your bones
  • have or have had too much calcium in your blood (hypercalcemia)
  • have or have had a skin condition with painful sores or wounds caused by too much calcium
  • have or have had kidney stones,
  • take medicines that contain digoxin,
  • are pregnant or plan to become 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 breastmilk. You should not breastfeed while taking FORTEO.

Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How to take

  • Use FORTEO exactly as your healthcare provider tells you to. Your healthcare provider will tell you how much FORTEO to use and when to use it.
  • 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. Read the detailed Instructions for Use (User Manual) included with your FORTEO delivery device.
  • Inject FORTEO 1 time each day in your thigh or abdomen (lower stomach area). Do not inject into a vein or a muscle. Talk to a healthcare provider about how to rotate injection sites.
  • When you inject the first few doses of FORTEO, make sure you are in a place where you can sit or lie down right away in case you feel dizzy or have an abnormal heartbeat after the injection.
  • Do not take more than 1 injection in the same day. Do not share your FORTEO delivery device with other people.
  • You should not use FORTEO for more than 2 years over your lifetime unless your healthcare provider finds that you need longer treatment because you have a high chance of breaking your bones.
  • Store FORTEO in the refrigerator between 36°F to 46°F (2°C to 8°C) until ready to use. Inject FORTEO right away after you take the delivery device out of the refrigerator. Do not freeze FORTEO.

Learn more

FORTEO is a prescription medicine available as a delivery device (pen). It is set to give a 20-microgram dose of medicine each day. Administer FORTEO as a subcutaneous injection into the thigh or abdominal region. Each device contains enough medicine for 28 days. For more information about FORTEO, call 1-866-436-7836 or go to www.forteo.lilly.com . See the User Manual that comes with the delivery device.

This summary provides basic information about FORTEO but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about FORTEO and how to take it. Your doctor is the best person to help you decide if FORTEO is right for you.

TE CON BS 03AUG2026

FORTEO® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

Please click to access Prescribing Information and Medication Guide . Please see Instructions for Use provided with delivery device.

INDICATIONS

FORTEO® (for-TAY-o) is a prescription medicine used to:

  • treat postmenopausal women who have osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments. FORTEO can lessen the chance of broken bones (fractures) in the spine and other bones in postmenopausal women with osteoporosis.
  • increase the bone mass in men with primary or hypogonadal osteoporosis who are at high risk for having broken bones (fractures) or who cannot use other osteoporosis treatments.
  • treat 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 (fractures) or who cannot use other osteoporosis treatments.

It is not known if FORTEO is safe and effective in children. FORTEO should not be used in children and young adults whose bones are still growing.