Please ensure JavaScript is enabled for purposes of website accessibility TEPEZZA® Side Effects and Safety | TEPEZZA® (teprotumumab-trbw)
chat-icon

Questions about TED or TEPEZZA® (teprotumumab-trbw)? Join us for
a live, online event with a TED Eye Specialist and TEPEZZA Patient!

P-TEP-US-01062 04/23

Questions about TED or TEPEZZA?
Call a Nurse Advocate at: 1-833-483-7399

TEPEZZA-teprotumumab-trbw-logo

Prescribing Information

Are you a US healthcare professional? If you are, click "Yes" to proceed. Otherwise, click "No" to remain on this page.
Yes No
link icon

Thank You!

We have sent your results to

Sign up to learn more
about TEPEZZA Find a
TED Specialist

TEPEZZA Side Effects and Safety

You should be aware of important risk information, including warnings and precautions, as well as the most common side effects.

Warnings and precautions

  • Infusion reactions: Infusion reactions can happen during a TEPEZZA treatment or within 24 hours after the treatment. Tell your doctor or a nurse right away if you have any of the following symptoms during or after treatment with TEPEZZA:
    • High blood pressure
    • Fast heartbeat
    • Redness of the face/Feeling hot
    • Difficulty breathing
    • Headache
    • Muscle pain
  • Inflammatory bowel disease: If you have inflammatory bowel disease (IBD), such as Crohn's disease or ulcerative colitis, TEPEZZA may make your IBD symptoms worse.
  • Blood sugar: TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.
  • Hearing problems: TEPEZZA may cause severe hearing problems including hearing loss, which in some cases may be permanent. Tell your doctor if you have any signs or symptoms of hearing problems or changes in hearing.

Most common side effects of TEPEZZA

Side effects % of patients who experienced the side effects in clinical studies Questions to ask your doctors
Muscle spasms 25%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Will things such as an ice pack, hot compress, or Epsom salt baths help me with muscle spasms?
Nausea 17%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Are there any liquids I should avoid when feeling nauseous? Are there any drinks like water or other clear liquids that I should drink to help with nausea?
Hair loss 13%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Will the hair loss stop after treatment?
Diarrhea 12%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Would fluids like coffee or alcohol make diarrhea worse? If so, would clear liquids like water or broth be better to drink?
Feeling tired 12%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Would it help to get a good night’s sleep before each infusion and schedule time afterwards to relax?
High blood sugar 10%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Be sure to talk with your doctor about having your blood sugar tested and tracked during treatment.

Here are some questions you may want to ask:

  • Who is going to perform the testing?
  • Who is going to review the results?
  • How often should levels be reviewed?
Hearing problems 10%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Watch this video to learn more about hearing problems.

Should I get a hearing test before starting treatment?

Taste changes 8%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

If things start to taste differently, what should I do?
Headache 8%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Would an over-the-counter pain medicine help me with headaches?
Dry skin 8%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Would an over-the-counter moisturizing lotion help me with dry skin?
Weight decrease 6%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Should I weigh myself regularly during treatment?
Nail Disorder 5%

of patients taking TEPEZZA

of patients taking TEPEZZA

Question to ask your doctor

Are there vitamins I can take to keep my nails healthy?

Contraindications: TEPEZZA has no known interactions with other medications.

Changes in menstruation: In clinical studies, about 23% (5 out of 22) of menstruating women saw changes in menstruation. These changes included missing period(s), spotting, and painful menstruation or cramps.

In clinical studies, most side effects were mild or moderate and could be managed by the doctors. Most side effects went away during or after treatment.

If you think you’re having a side effect, talk to your doctor or nurse right away. They will probably want to know a few things about what you’re going through. Write down your answers to these questions so you can refer to them later:

  • What side effect or issue are you experiencing?
  • What date did you first notice it?
  • Do you still have the side effect, or did it go away? When?

Please enter your name & email

Back to top

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TEPEZZA?

Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.

Tell your doctor or nurse right away if you have any of these symptoms during or after your treatment with TEPEZZA:
  • High blood pressure
  • Fast heartbeat
  • Redness of the face/Feeling hot
  • Difficulty breathing
  • Headache
  • Muscle pain

TEPEZZA may worsen inflammatory bowel disease (IBD), such as Crohn’s disease or ulcerative colitis, even if you don’t have a diagnosis of IBD before starting TEPEZZA treatment. Tell your doctor right away if you have worsening IBD symptoms, which may include diarrhea with stomach pain or cramps, blood in your stools, sudden urgency to have a bowel movement, or feeling like you need to have a bowel movement even when there’s little or no stool to pass.

TEPEZZA may cause an increase in your blood sugar. Before starting treatment with TEPEZZA, tell your doctor if you are currently being treated for diabetes, know your blood sugar is high, or have been diagnosed with diabetes. It is important for you to take your treatments and follow an appropriate diet for glucose control as prescribed by your doctor.

TEPEZZA may cause severe hearing problems including hearing loss, which in some cases may be permanent. Tell your doctor if you have any signs or symptoms of hearing problems or changes in hearing.

Before receiving TEPEZZA, tell your doctor if you:
  • Have inflammatory bowel disease (Crohn's disease or ulcerative colitis).
  • Are currently being treated for diabetes, have been diagnosed with diabetes, or know your blood sugar is high.
  • Are pregnant or plan to become pregnant. TEPEZZA may harm your unborn baby. Tell your doctor if you become pregnant or suspect you are pregnant during treatment with TEPEZZA.
    • Women who are able to become pregnant should use an effective form of birth control (contraception) prior to starting treatment, during treatment and for at least 6 months after the final dose of TEPEZZA.
  • Are breastfeeding or plan to breastfeed. It is not known if TEPEZZA passes into your breast milk. Talk to your doctor about the best ways to feed your baby during treatment with TEPEZZA.
  • Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, dietary and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
What are the possible side effects of TEPEZZA?

The most common side effects of TEPEZZA include muscle cramps or spasms, nausea, hair loss, diarrhea, feeling tired, high blood sugar, hearing problems, taste changes, headache, dry skin, ear discomfort, weight loss, nail problems, and changes in menstruation.

This is not a complete list of all possible side effects. Tell your doctor or treatment team about any side effect you may have.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/safety/medwatch, or call 1-800-FDA-1088.
Please see Full Prescribing Information or visit TEPEZZA.com for more information.

USE

TEPEZZA is a prescription medicine used to treat Thyroid Eye Disease (TED), no matter if you’ve had TED for months or years.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about TEPEZZA?

Infusion reactions can happen during or within 24 hours after your infusion of TEPEZZA. If you have a reaction while receiving TEPEZZA, your doctor or nurse will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction, your doctor may stop your treatment completely.