Brand name · Tirzepatide

Zepbound: adverse event reports filed with FDA

63,628 reports list it as a suspect or interacting product, 2019–2026. Class: GLP-1 receptor agonist.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

63,628
reports as suspect product: 0.3% of all reports · about 9,671 a year; 40,900
reports, 12 months to June 2026: 18,932 in the 12 months before; 6.2%
marked serious by the reporter: 28% across the class; 0.2%
record death among outcomes, as reported: 117 reports · not verified by FDA

63,628 adverse event reports received by FDA list the brand name Zepbound (tirzepatide) as a suspect or interacting product, from December 2019 to June 2026. A further 1,321 reports list it only as a concomitant medication, and those are not counted in the figures on this page.

In the 12 months to June 2026, 40,900 reports listed it, up 116% from 18,932 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 9,671 reports a year and 0.3% of the 20,646,523 reports in the database, and 15.7% of the reports for the GLP-1 receptor agonist class. How many people take it is not in the data, so a count is not a rate of occurrence.

Reporters most often recorded incorrect dose administered (19.2%), nausea (11.2%) and injection site pain (7.2%). A report can list several reactions, so shares add to more than 100%; 1,236 different terms appear across these reports. Incorrect dose administered is recorded in 19.2% of these reports, a larger share than in the median GLP-1 receptor agonist drug (1.3%).

6.2% of the reports are marked serious by the reporter (28% across the class); 0.2% record death among the outcomes and 2.3% record hospitalisation, as reported. 96% of the reports came from consumers, and the largest patient age group is 45 to 64 (33.6%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Zepbound reports recording the termmedian drug in glp-1 receptor agonist

Incorrect dose administeredthe wrong dose was given19.2%12,202
Nauseafeeling sick11.2%7,115
Injection site painpain where the injection was given7.2%4,573
Extra dose administered6.9%4,385
Drug ineffectivethe medicine did not work as expected6.6%4,221
Diarrhoealoose or frequent stools6.1%3,850
Vomitingbeing sick4.7%3,006
Constipationconstipation4.3%2,715
Accidental underdose4.1%2,603
Therapeutic response changed3.5%2,212
Fatiguetiredness3.3%2,089
Injection site erythemaredness where the injection was given3.3%2,073
Weight increasedweight gain2.7%1,721
Injection site haemorrhagebleeding where the injection was given2.7%1,695
Alopeciahair loss2.4%1,516
Abdominal pain upperupper stomach pain2.3%1,481
Injection site bruisingbruising where the injection was given2.2%1,394
Product dose omission issuea dose was missed2.1%1,314
Injection site reactiona reaction where the injection was given2.1%1,311
Headachehead pain2%1,293
Eructation2%1,262
Injection site pruritusitching where the injection was given2%1,243
Illness1.9%1,208
Dyspepsiaindigestion1.8%1,168
Off label useused for a purpose or in a way not on the label1.8%1,118
Dizzinesslight-headedness or unsteadiness1.7%1,098
Abdominal discomfortstomach discomfort1.5%970
Hunger1.5%936
Injection site rash1.3%823
Gastrooesophageal reflux diseaseacid reflux1.2%779

Top 30 of 1,236 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 18 drugs in the glp-1 receptor agonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Death0.2%117

Life-threatening0.1%75

Hospitalisation (initial or prolonged)2.3%1,456

Disability0.2%124

Congenital anomaly0%6

Other serious3.8%2,440

Not serious93.8%59,654

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 404,853 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Patient age

Under 20%7

2 to 110%1

12 to 170%13

18 to 4418%11,454

45 to 6433.6%21,380

65 to 7413.9%8,860

75 and over5.3%3,395

Age not given29.1%18,518

Patient sex

Female62.1%39,502

Male15%9,520

Not given23%14,606

Who reported

Physician0.9%562

Pharmacist0.4%246

Other health professional2.6%1,650

Lawyer0.1%32

Consumer or non-health professional96%61,103

Not given0.1%35

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.9% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)	Reports	Share
Weight control	27,138	42.7%
Sleep apnoea syndrome	649	1%
Weight decreased	472	0.7%
Obstructive sleep apnoea syndrome	437	0.7%
Obesity	272	0.4%
Glucose tolerance impaired	271	0.4%

The indication field is filled in by the reporter and is often blank; shares are of all 63,628 reports.

In context

Measure	Zepbound	GLP-1 receptor agonist	All reports
Reports as suspect product	63,628	404,853	20,646,523
Share of that pool	—	15.7%	0.3%
Reports, latest 12 months	40,900	—	1,332,454
Marked serious	6.2%	28%	57.4%
Death recorded among outcomes, per 1,000 reports	2	15	91
Hospitalisation recorded, per 1,000 reports	23	113	213
Consumer-filed share	96%	82%	45.8%
Top term, share of reports	Incorrect dose administered 19.2%	median 1.3%	1.1%

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the glp-1 receptor agonist class

Drug	Name type	Reports	Latest 12 months	Marked serious
Mounjaro	brand	85,842	26,334	23.6%
Trulicity	brand	75,864	4,282	20.7%
Ozempic	brand	52,881	21,704	48.8%
Byetta	brand	47,928	12	24.7%
Victoza	brand	28,899	998	41.8%
Wegovy	brand	19,509	11,958	45.4%
Saxenda	brand	6,598	471	47.3%
Rybelsus	brand	6,055	1,532	56%
Semaglutide	generic	4,499	1,830	71%
Soliqua 100/33	brand	3,153	413	14.6%
Tirzepatide	generic	2,522	1,257	58.4%
Zepbound Kwikpen	brand	2,396	2,396	5.1%
Liraglutide	generic	1,446	475	66.2%
Insulin degludec and liraglutide	generic	1,197	141	72.9%
Dulaglutide	generic	994	104	68.3%

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Questions about Zepbound reports

How many adverse event reports has FDA received for Zepbound?

63,628 reports list Zepbound as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 40,900 of them arrived in the latest 12 months. Another 1,321 list it only as a concomitant medication.

What reactions are recorded in Zepbound reports?

incorrect dose administered (19.2%), nausea (11.2%), injection site pain (7.2%), extra dose administered (6.9%) and drug ineffective (6.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Zepbound was responsible.

How serious are the reports?

6.2% are marked serious by the reporter. Among the outcomes recorded, 0.2% of reports include death and 2.3% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

consumer or non-health professional (96%), other health professional (2.6%) and physician (0.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Zepbound rising?

40,900 reports in the 12 months to June 2026, up 116% from 18,932 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Zepbound was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Zepbound?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Zepbound as a suspect or interacting product; reports listing it only as a concomitant medication (1,321) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

What a report is

One submission to FDA about one patient: the products involved, the reactions coded with MedDRA terms, outcome flags, the patient's age and sex, and who reported. Most arrive through manufacturers, who must forward what they receive.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts reports where Zepbound is suspect or interacting; 1,321 more list it only as a concomitant medication.

Class comparison

The hollow bars and grey bars use the glp-1 receptor agonist class (18 drugs, 404,853 reports). The class comes from the pharmacologic class (EPC) on the FDA label. Class page.

Data version

openFDA FAERS release of 28 Sep 2026; reports received through 30 Jun 2026. Rebuilt daily.

Report an event

FDA MedWatch: Form FDA 3500 or 1-800-FDA-1088. How to report.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.