Tepezza Hearing Loss & Tinnitus Lawsuit

Tepezza is a treatment for thyroid eye disease (TED), which is sometimes known as Graves ophthalmopathy. The autoimmune disease is characterized by eye protrusion (bulging), swelling, inflammation, eyelid retraction, and other symptoms relating to the eyes. Approved by the FDA to treat TED in January 2020, the application of Tepezza medication involves an IV (intravenous) infusion. However, while Tepezza has been shown to be effective in combating the symptoms of TED, plaintiffs in the Tepezza hearing loss lawsuits claim there are dangerous Tepezza side effects. Most notably, hearing loss and other ear problems. Those launching the lawsuits against Tepezza’s manufacturers, Horizon Pharmaceuticals, have been backed up in their claims by a number of independent studies on the association between Tepezza and hearing loss.

Approved by the FDA to treat TED in January 2020, Tepezza is administered via an IV (intravenous) infusion. While Tepezza is proven effective in combating TED symptoms, plaintiffs in the Tepezza hearing loss lawsuits claim the drug carries dangerous side effects—most notably, permanent hearing loss and other auditory problems. Those launching lawsuits against Tepezza’s manufacturers, Horizon Pharmaceuticals, have been supported by a number of independent studies on the association between Tepezza and hearing loss.

Tepezza is a drug prescribed for thyroid eye disease (TED), designed to alleviate the eye pain, redness, swelling, bulging, and double vision often associated with the condition. Many people who were prescribed Tepezza to treat the symptoms of thyroid eye disease suffered from temporary or permanent hearing loss and tinnitus and were not adequately warned about the seriousness of Tepezza side effects. 

Horizon Pharmaceuticals, the company that makes Tepezza, initially did not warn patients about the potential of hearing loss at all—it wasn’t mentioned as a possible side effect in the leaflet packaged with the drug. Tepezza was approved by the FDA in 2020, and Horizon did not add hearing loss as a potential side effect until 2022. 

The 2022 Tepezza warning label informed patients and physicians that potential hearing loss associated with the drug was mild and reversible. This wasn’t the case for many people who used the drug to treat TED. For some people who used Tepezza, their hearing loss became permanent, remaining unchanged even after they stopped using the drug. In 2023, Horizon finally changed the warning label for Tepezza, indicating that hearing loss associated with Tepezza use could be permanent. 

According to a 2022 study, the prevalence of hearing problems among patients who use Tepezza may be as high as 81.5%. Understandably, many people who use Tepezza are suffering due to the life-altering effects of the drug. If you or a loved one used Tepezza and are now experiencing tinnitus, hearing loss, or other auditory conditions, you’re not alone, and you may be entitled to compensation. 

Tepezza lawyers across the United States are working to fight for your right to compensation for your pain, damages, and suffering related to Tepezza use. While these lawsuits are still in the early stages, it’s likely that Tepezza lawsuits will be consolidated into class action or multidistrict litigation (MDL) lawsuits. 

April 1, 2025

Tepezza Marketing, Sales Practices, and Products Liability Litigation.

February 1, 2025

The Tepezza multidistrict litigation (MDL No. 3079) is progressing through its pretrial phases under the guidance of the U.S. District Court for the Northern District of Illinois. The court has issued several case management orders to structure the proceedings, including the selection and preparation of bellwether trials.

• January 1, 2025 - Viridian readies for Tepezza rivalry with new Phase 3 data in thyroid eye disease.
• December 1, 2024 - The newly added warning from the FDA says TEPEZZA may cause severe hearing impairment including hearing loss.
• November 1, 2024 - Horizon Defeats Bellwether Suit Over Teppeza Hearing Loss Claims
• August 1, 2024 - Recent lawsuits claim that Horizon Therapeutics, the manufacturer, did not sufficiently warn about the potential for hearing damage. These cases are in the early stages of litigation​.
• July 1, 2024 - Study finds TEPEZZA demonstrates extended benefits in Thyroid Eye Disease patients
• June 1, 2024 - Teprotumumab Treats Thyroid Eye Disease Across Age
• May 1, 2024 - A Study Evaluating Tepezza Treatment in Patients With Chronic (Inactive) Thyroid Eye Disease.
• April 1, 2024 - ACELYRIN (SLRN) Up on Data From Thyroid Eye Disease Study.
• March 1, 2024 - Teprotumumab-Trbw (Intravenous Route) US Brand Name: Tepezza
• ebruary 1, 2024 - Tepezza side effects: What you should know?
• January 19, 2024 - How Graves' Disease Affects the Eyes - Graves' disease can cause the immune system to damage the tissues and muscles around the eyes. This can cause symptoms such as inflammation and bulging.
• January 1, 2024 - Your Guide to Tepezza for Thyroid Eye Disease
• December 1, 2023 - Amgen's plan to boost sales of the recently acquired TED drug is a response to Tepezza's stagnant sales.
• November 6, 2023 - Tepezza plaintiffs who link the thyroid eye disease drug to hearing loss advanced claims alleging that manufacturer Horizon Therapeutics should have designed a safer medication before it sought marketing approval.
• November 1, 2023 - Amgen acquires Horizon Therapeutics, Inc. for US$27.8 billion. Horizon Therapeutics develops medicines for rare autoimmune diseases and severe inflammatory conditions. Tepezza is a prescription medication used to treat Thyroid eye disease (TED).
• October 1, 2023 - Tepezza Studies Show Connection Between Hearing Risks and Thyroid Autoimmunity.
• September 1, 2023 - The Federal Trade Commission will allow pharmaceutical giant Amgen to move ahead with its acquisition of Horizon Therapeutics, averting a trial (involved Horizon’s Tepezza lawsuit) set for September 2023.
• August 1, 2023 - Viridian looks over Horizon after eye disease med notches early improvements.
• July 24, 2023 - FDA adds hearing loss and impairment warnings to Tepezza label.
• June 1, 2023 - Tepezza is approved for Thyroid eye disease regardless of the severity or duration.
• May 1, 2023 - A lawsuit alleges that Horizon Therapeutics' Teprotumumab trbw (Teprotumumab-trbw is an injection is used to treat thyroid eye disease) caused permanent hearing damage.
• April 1, 2023 - Increased risk of hearing impairment with Tepezza thyroid eye disease treatment.
• February 1, 2023 - Smoking increases the risk of having surgery for thyroid eye disease.
• January 1, 2023 - Tepezzas Teprotumumab-Trbw (Intravenous Route) Side Effects Update Mayo Clinic

As of late 2022, law firms are calling for those affected by Tepezza injuries to come forward and file a claim. Tepezza lawsuits have already been launched, including a Tepezza hearing loss lawsuit on behalf of Daniel Weibel in the Northern District of Illinois. Claimants are not filing based on their personal experiences; they are backed up by the findings of independent studies on the Tepezza ear damage dangers. This includes a study published by the Endocrine Society in March 2021, which claimed that 65% of patients taking Tepezza might experience otologic (relating to the ear) symptoms. While, as mentioned, thyroid eye disease is relatively rare, the high rate of hearing loss, tinnitus, and other ear problems means a significant number of claimants could join those who have already filed hearing loss lawsuits against the manufacturer, Horizon Pharmaceuticals.

Tepezza is a brand name for the teprotumumab, a medication used to treat thyroid eye disease (TED), an autoimmune inflammatory disorder characterized by swelling and protrusion of the eye area, as well as other linked symptoms. 

Tepezza gained FDA approval in 2020 after two studies showed the drug successfully reduced proptosis (eye protrusion). However, patient experience and peer-reviewed research studies show that Tepezza can also cause temporary or permanent hearing loss, tinnitus, and/or ear damage. Perhaps as many as 10% of Tepezza patients have reported ear and hearing damage. Tepezza lawsuit claimants allege that Tepezza’s manufacturer, Horizon Pharmaceuticals, did not do enough to warn patients or healthcare providers about the hearing-related side effects of the drug.

Thyroid eye disease (TED) is a relatively rare condition estimated to impact around 3 in 100,000 men and about 16 in 100,000 women. Roughly 3-5% of cases are deemed intense, causing severe pain and potentially leading to blindness. Tepezza was labeled a “first-in-class” medicine by the FDA, meaning it was considered a breakthrough therapy. Thyroid eye disease is not curable—Tepezza is used to treat the symptoms of the condition.

Graves’ disease is a condition of the thyroid, usually resulting in hyperthyroidism (the overproduction of thyroid hormones). One of the several symptoms of Graves’ disease is Graves’ ophthalmopathy, which is another name for thyroid eye disease. Tepezza is not used to treat Graves’ disease directly, but to alleviate the symptoms – swelling, bulging, etc. – of Graves’ ophthalmopathy/thyroid eye disease.

Side effects	% of patients who experienced & took Tepezza	People in the clinical studies experienced
Muscle spasms	25%	Muscle spasms are usually managed by patients who have muscle spasms. Clinical studies showed that muscle spasms did not cause patients to stop taking Tepezza.
Nausea	17%	Some patients felt nauseated or queasy after the 2nd infusion.
Hair loss	13%	Some people had hair loss during treatment. With the exception of one case of moderate hair loss, all cases were mild.
Diarrhea	12%	Most cases of diarrhea were mild. One person experienced severe diarrhea. This person had a history ulcerative colitis (IBD), which affects the colon.
Fatigue	12%	Some people feel tired and lack of energy. Two people described mild cases of tiredness, and most people reported feeling tired.
High blood sugar	10%	Some people with diabetes have blood sugar levels that are higher than normal. However, their doctors managed to control these levels. Diabetes patients may have higher blood sugar levels. This was treated by changing their diabetes medication.
Hearing problems	10%	There were some people who had hearing problems, such as deafness or having one or both of their ears plugged with fluid.
Taste changes	8%	Some people reported changes in their taste. All cases of taste changes were mild.
Headache	8%	All headaches were mild.
Dry skin	8%	All cases of dry skin were mild.

Source: Tepezza Website

The FDA approved Tepezza in January 2020. Other thyroid eye disease drugs and treatments existed previously, but Tepezza was hailed as a breakthrough medication. The application for approval sought by Horizon Pharmaceuticals was given “Priority Review” status by the FDA, meaning it was fast-tracked for approval. 

A crucial point to consider is that Tepezza was initially given “Orphan Drug” designation. This is a strategy employed by the FDA when alternative treatments are not available. Essentially, it meant Tepezza was given a kind of preliminary approval status, even though itrequired further clinical tests. The FDA now lists hearing loss, among other side effects, as possible adverse reactions for those taking Tepezza.

Horizon Therapeutics USA Inc. is facing a new class action lawsuit for Tepezza. The lawsuit claims that Horizon Therapeutics USA Inc. failed to warn of the potential hearing loss and Tinnitus caused from their thyroid eye disease drug Tepezza.

The FDA lists several Tepezza side effects, and there have been some side effects not recorded by the FDA reported by Tepezza lawsuit claimants. The FDA’s Tepezza side effects list includes muscle spasms, nausea and vomiting, alopecia (hair loss), diarrhea, fatigue, high blood sugar, dry skin, dysgeusia (problems with the sense of taste), and headaches. However, the Tepezza lawsuits concentrate on ear damage symptoms. These include:

• Eustachian tube dysfunction, which causes pressure aberrations in the middle ear
• Hyperacusis, a hearing condition that causes increased sensitivity to sounds
• Permanent hearing loss
• Partial hearing loss
• Autophony, a disorder that causes your voice to echo in your ear
• Tinnitus – ringing in the ear

Long-Term Side Effects of Tepezza

Tepezza is a relatively new medication, having only been approved by the FDA less than two years ago. Thus, long-term Tepezza side effects might not become apparent for many years, or at least until more clinical tests have been carried out. However, we know that some potential side effects – like loss of hearing – could be permanent.

One of the most worrying aspects of Tepezza is the link to the treatment and hearing loss, particularly permanent hearing loss. In one study, up to 23% of participants experienced hearing loss after taking Tepezza. We should stress that many of these studies have a small sample size (due to the rarity of thyroid eye disease). Moreover, Tepezza is a new drug, so it’s not abundantly clear as to its impact on hearing loss over a longer period.

What are the symptoms of Tepezza hearing loss? Beyond the obvious – loss of hearing – those experiencing problems might have the following symptoms:

• Pain in the ears
• Ringing (Tinnitus)
• Autophony (echoing)
• Discomfort – feeling of having plugged ears
• Increased sensitivity, including that one’s own voice is louder

Please note that the symptoms of Tepezza hearing loss can also be considered Tepezza injuries in and of themselves. The current Tepezza lawsuits are open to anyone who has suffered ear damage due to having treatment with this medication, not just those who have suffered hearing loss.

If you have been treated for thyroid eye disease with Tepezza and have suffered an injury, you may be entitled to compensation. Tepezza lawsuit lawyers are asking for claimants to come forward, believing that the case against Horizon could become a national case. 

Right now, Horizon Pharmaceuticals has been named as a defendant in existing lawsuits, and Tepezza injury law firms hope that more people coming forward will add to the weight of evidence against the company. If you believe you have been injured by Tepezza, reach out to us for a case review. If you qualify, we’ll connect you with a personal injury lawyer learn whether you may be eligible for compensation.

The Tepezza lawsuits are still at an early stage, and it will likely take sme time before litigation concludes. As such, it is not clear how much claimants will receive for a Tepezza settlement. Much depends on the evidence provided in the court proceedings, including whether Horizon Pharmaceuticals knew Tepezza could cause hearing loss and whether the company was negligent. It is possible that Horizon Pharmaceuticals could settle out of court, agreeing to pay a sum of money to end the case without a trial.

Law firms representing individual claimants have filed Tepezza lawsuits across the country. It is possible that Tepezza cases will be consolidated into a class-action or multidistrict litigation lawsuit. Thus, new claimants would join an existing group. For now, however, anyone wishing to learn more about Tepezza compensation should reach out to us today for a free case evaluation. If you’re likely to qualify for compensation, we’ll connect you with a Tepezza lawsuit lawyer who can help you get the financial support you deserve.

What is the Tepezza hearing loss about?

Tepezza is a drug used to treat thyroid eye disease. However, it seems to have a side effect that can cause hearing loss and other types of ear damage. Those pursuing compensation claim that the manufacturer of Tepezza, Horizon Pharmaceuticals, did not do enough to warn of this side effect.

What is Tepezza used for?

Tepezza is a relatively new treatment for TED (thyroid eye disease), which is also known as Graves’ ophthalmopathy.

How does Tepezza work?

It isn’t fully understood how Tepezza works, although we do know that it helps protect the muscles and fatty areas around the eyes from the body’s immune system, which can produce too much thyroid hormone in those with thyroid eye disease or Graves’ disease.

Is Tepezza chemotherapy?

No. Tepezza is not chemotherapy. Initial research for the drug showed promise in treating tumors and cancers, but this was later discontinued.

What company makes Tepezza?

Tepezza is the brand name for teprotumumab. It is produced by Horizon Pharmaceuticals, Inc. The company has been named as the main defendant in the Tepezza hearing loss lawsuits.

What is Tepezza made of?

Tepezza is a biologic medication, meaning it is (partly) composed of living organisms.

Is Tepezza hearing loss reversible?

The full and long-term extent of Tepezza hearing loss side effects is not known. However, some of the claimants in the Tepezza lawsuits believe they have suffered permanent hearing loss.