Tepezza Side Effects and Safety: What the FDA Record Shows

Tepezza Side Effects are documented on the FDA prescribing label, and reported separately by patients and doctors to the FDA’s adverse event system. This page sets out what the official record actually says about Tepezza: what it is approved to treat, what the label warns about, its recall history, and what the reported side effects are — along with what those figures do and do not mean.

What Tepezza Is Prescribed For, and Where Tepezza Side Effects Come From

According to the FDA label, is indicated for the treatment of Thyroid Eye Disease regardless of Thyroid Eye Disease activity or duration. TEPEZZA is an insulin-like growth factor-1 receptor inhibitor indicated for the treatment of Thyroid Eye Disease ( 1 )

Two separate official sources describe tepezza side effects. The prescribing label records what was observed in clinical trials, where the drug was compared against a control group. The FDA’s adverse event database records what patients and clinicians have reported since approval, which is a much larger but far less controlled picture. Both appear below, and they answer different questions.

The FDA has revised this label recently. The label’s own record of recent major changes reads: Dosage and Administration, Administration ( 2.3 ) 9/2025 Warnings, and Precautions, Inflammatory Bowel Disease ( 5.2 ) 8/2025 A recent revision usually means new safety information was added.

Warnings on the Tepezza Label

The FDA prescribing label carries the full set of warnings and precautions for Tepezza. Because a medicine can have several approved labels from different manufacturers and formulations, the safest way to see the warnings that apply to the exact product you have is to read the label for that product.

You can look up any product’s current FDA label on DailyMed, the National Library of Medicine’s official label database, using the name on your bottle or box.

Warnings Beyond the Common Tepezza Side Effects

The label’s warnings and precautions section describes risks the FDA requires prescribers to weigh. For Tepezza it covers: nfusion Reactions : If an infusion reaction occurs, interrupt or slow the rate of infusion and use appropriate medical management ( 5.1 ) Inflammatory Bowel Disease (IBD) : Monitor patients; for signs and symptoms of disease, including patients without a history of IBD; discontinue TEPEZZA if IBD exacerbation is suspected ( 5.2 ) Hyperglycemia : Assess patients for elevated blood glucose and symptoms of hyperglycemia prior to infusion and continue to monitor while on treatment with TEPEZZA.

Ensure patients with hyperglycemia or preexisting diabetes are under appropriate glycemic control before and while receiving TEPEZZA ( 5.3 ) Hearing Impairment Including Hearing Loss: TEPEZZA may cause severe hearing impairment including hearing loss, which in some cases may be permanent. Assess patients' hearing before, during, and after treatment with TEPEZZA and consider the benefit-risk of treatment with patients ( 5.4 ) 5.1 Infusion Reactions TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. […]

These are the risks the FDA has judged significant enough to state formally, and they sit apart from the routine tepezza side effects most people ask about. They apply to different patients to very different degrees, which is why the same medicine can be routine for one person and unsuitable for another.

Tepezza Side Effects Listed on the FDA Label

The label’s adverse reactions section records what was observed in clinical trials: he following clinically significant adverse reactions are described elsewhere in the labeling: Infusion Reactions [see Warnings and Precautions (5.1) ] Inflammatory Bowel Disease [see Warnings and Precautions (5.2) ] Hyperglycemia [see Warnings and Precautions (5.3) ] Hearing Impairment Including Hearing Loss [see Warnings and Precautions (5.4) ] Most common adverse reactions (incidence greater than 5%) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dry skin, dysgeusia, headache, weight decreased, and nail disorder ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. […]

Trial data is the most reliable source for how common tepezza side effects are, because the people taking the drug were compared against people who were not. A symptom that appeared just as often in the control group is not caused by the medicine.

Reported Tepezza Side Effects in the FDA Database

Who the Label Says Should Take Extra Care

Contraindications. The label states that Tepezza should not be used in certain situations: one. None ( 4 )

Older adults. 8.5 Geriatric Use Of the 171 patients in the two randomized trials, 15% were 65 years of age or older; the number of patients 65 years or older was similar between treatment groups. No overall differences in efficacy or safety were observed between patients 65 years or older and younger patients (less than 65 years of age).

Your pharmacist can check your full medicine list against this in a couple of minutes, including anything bought over the counter, and that check is free.

Tepezza Recall History

The FDA’s enforcement database shows no recall records for Tepezza products in the period covered by the current data. That is a statement about recalls of the product, not about the medicine’s safety profile, which is a separate question addressed by the label and the warnings on it.

Recalls are usually about a manufacturing or packaging problem affecting particular batches, not about the medicine itself. You can check for current recalls any time on the FDA recalls page.

Is There Litigation Involving Tepezza?

Lawsuits involving Tepezza have been filed in the United States. A lawsuit is an allegation: it means claimants assert that a manufacturer failed to warn adequately or that a product was defective. It is not a finding that the medicine caused any particular person’s illness, and courts have not necessarily reached any conclusion.

Whether any individual claim has merit depends on medical records, timing and the law in that person’s state. Our case pages track the current status of the litigation itself.

Read the current case status and filing information →

Litigation Timeline

If You Are Worried About Tepezza Side Effects

Concern about tepezza side effects is a good reason to have a conversation, and not a reason to act alone. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first. Stopping some medicines abruptly carries risks of its own, and your prescriber can tell you whether that applies to yours.

Write down what you have noticed and when it started before the appointment. Not everything that happens while taking a medicine is one of its tepezza side effects, and a specific account — what changed, when, and how often — is what lets a clinician tell the difference.

You can also report a side effect directly to the FDA through MedWatch. Reports from patients are part of how safety signals are detected, and filing one takes a few minutes.

Frequently Asked Questions

What are the most commonly reported tepezza side effects?

In FDA reports, the most frequently mentioned are muscle spasms, fatigue, tinnitus. The label’s own adverse reactions section, drawn from clinical trials, is the better guide to how common a side effect actually is, because reports to the FDA are not collected in a way that supports rates.

Has Tepezza been recalled?

The FDA enforcement database shows no recall records for Tepezza products in the current data. Check the FDA recalls page for anything more recent.

Does Tepezza have a boxed warning?

A medicine can have several approved labels from different manufacturers, so the reliable answer for the exact product you have is on that product’s label. You can look it up on DailyMed using the name on your packaging.

Do the FDA report numbers tell me how common these tepezza side effects are?

No. Reports are unverified, anyone can file one, and the total mostly reflects how many people take the medicine and how much attention it is getting. A high count is not evidence of danger, and a low one is not evidence of safety. Clinical trial data on the label is the source that supports rates.

Where can I check tepezza side effects for the exact product I have?

DailyMed holds the current FDA label for every marketed product, searchable by the name on your packaging. Different manufacturers and formulations of the same medicine can have slightly different labels, so checking the one you actually have is worth the two minutes.

Official Sources

• DailyMed (National Library of Medicine) — the current FDA prescribing label for every product
• FDA Adverse Event Reporting System dashboard — the public report data summarised above
• FDA recalls and safety alerts — current recall notices
• FDA MedWatch — how to report a side effect yourself

Related Guides

• All Drug Safety Profiles
• Drug Safety Explainers
• Product Recalls
• Active Case Pages

Medical and legal disclaimer. This page summarises publicly available FDA data about Tepezza and is general information, not medical advice, and not legal advice. It is not a substitute for the judgement of a clinician who knows your medical history. Nothing here states that Tepezza caused any illness or injury in any individual. Adverse event reports are unverified and do not establish causation.

FDA labels are revised regularly; confirm current information on DailyMed or with your pharmacist. Do not stop taking a prescribed medicine, or change how you take it, because of anything you read here. Talk to the prescriber or pharmacist who knows your medical history first.