Tepezza Side Effects

As of September 2024, the most common Tepezza side effects reported to the U.S. Food and Drug Administration were muscle spasms, fatigue, hearing loss and tinnitus.
These four side effects accounted for more than half of all adverse event reports to the FDA.

FAERS data shows that muscle spasms and fatigue are the most likely adverse reactions to Tepezza. Other reactions include hearing disorders such as tinnitus and hearing loss. Tinnitus is a persistent ringing in one or both ears. Patients taking Tepezza should note any new or worsening conditions to determine if they are related to the infusions.

Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.

A 2024 study in Cureus followed a small group of patients through an entire course of infusions. It noted hair loss and new or increased dry eye, fatigue, brittle nails and dry mouth as the most common side effects. These occurred in over 50% of patients. Over 30% had tinnitus, dizziness, stomach issues or high blood sugar. Hearing loss affected just over 28% of study participants.

Tepezza is a relatively new medication that received fast-tracked FDA approval in 2020 after limited studies on its long-term side effects. The FDA added label warnings about hypoglycemia in December 2022 and hearing impairment in July 2023.

FDA Warnings and Actions

The FDA updated Tepezza packaging with safety information and warnings three times. The first update added information on fetal harm, infusion reactions, high blood sugar and worsening existing IBD symptoms.

In December 2022, the agency required additional information about hyperglycemia. Specifically, prescribing information now includes instructions to check patients for elevated blood glucose levels before and during treatment.

In July 2023, the manufacturer added another warning about hearing loss. The update urges health care providers to counsel patients about this risk.

These are standard warnings included on Tepezza’s label. The FDA currently requires no boxed warnings for adverse effects.

Clinical trials showed that muscle spasms and nausea were the most common side effects of Tepezza infusions. These occurred in 17% or more of the study participants. Many common Tepezza side effects are mild and do not require treatment discontinuation.

Other common symptoms, reported by 5% to 8% of participants, include changes in their sense of taste, headache, dry skin, weight loss and nail disorders such as brittle nails.

There was also a significant rate of menstrual disorders. Approximately 23% of menstruating people taking Tepezza as part of the study experienced period irregularities. This included breakthrough bleeding and skipped or painful periods, compared to 4% of those taking a placebo.

Hearing loss is a common and serious side effect associated with Tepezza. Hearing impairment and other ear-related problems occurred in 10% of clinical study participants.

Approximately 10% of study participants receiving Tepezza infusions developed hyperglycemia, which is high blood sugar. This is compared to 1% of participants receiving a placebo. Approximately 4% of patients also experienced infusion reactions.

If this occurs, you may need to discontinue its use. Discuss this possibility with your doctor before starting Tepezza so you can develop an appropriate monitoring program.
Tepezza has several potentially serious side effects that can lead to permanent damage. You should report any severe adverse effects to your health care provider immediately. Additionally, mild or moderate symptoms that last more than a few days after an infusion may need medical attention.

Infusion Reactions

According to the prescribing information, infusion reactions affected about 4% of Tepezza patients. They can develop during the infusion or up to 1.5 hours after.

These symptoms are generally mild to moderate. Antihistamines and corticosteroids are the preferred treatment option. If you have an infusion reaction, you may need to take preventative medications before future treatments to prevent it from happening again. Slower infusion rates may also help.

Tepezza’s initial trials found hearing loss or tinnitus in about 10% of the study participants. Since then, newer research has built upon existing data connecting Tepezza with hearing loss. For example, a data review published in Cureus in 2024 showed that as many as 65% of patients may experience some hearing loss or other ear-related side effects from Tepezza.

Lawsuits filed by or on behalf of patients who experienced hearing loss allege the manufacturer failed to adequately warn them of the risk. Judges combined these Tepezza lawsuits into a multidistrict litigation in June 2023.

Horizon Therapeutics added a warning about hearing loss to Tepezza packaging in July 2023.

Some patients reported ear-related symptoms other than hearing loss when taking Tepezza. These may present as tinnitus, echoing or the feeling of ears being plugged. Symptoms often resolve after discontinuing Tepezza, but hearing loss can become permanent in severe cases.

Having a baseline hearing test done before taking Tepezza is a good idea. This can help identify any deficiencies that may develop and monitor for a return to normal after stopping the medication.

Editor Lindsay Donaldson contributed to this article.