8 FDA label and trial tables · Checked

Shot-site reactions vs placebo, out of 100 people

Zepbound label

Placebo2%
On Zepbound (by dose)6% to 8%

In the Zepbound label, 6% to 8% on Zepbound (by dose) had shot-site reactions, like redness, itching, or bruising. On placebo, 2% did.

Every table that lists shot-site reactions

Each dot is 1 in 100 people.

Reported it Rest of a dose range Did not report it

Filled dots show the low end of a range. Dots are rounded. The exact number is above each grid.

FDA-approved medicines

EgriftaFDA-approved product

Adults with HIV and extra belly fat

Row in the source: Reactions where the shot was given

Placebo6%
On Egrifta17%
Who was studied
Adults with HIV and lipodystrophy in placebo-controlled trials. 543 got Egrifta and 263 got placebo.
How long
26 weeks
Source
Egrifta WR prescribing information on DailyMed . FDA label revised March 2025.

SaxendaFDA-approved product

Saxenda trials in adults with obesity or overweight

Row in the source: Reactions where the shot was given

Placebo10.5%
On Saxenda13.9%
Who was studied
Adults with obesity or overweight in 5 trials. 3,384 got Saxenda and 1,941 got placebo. 15% had type 2 diabetes. Everyone also got advice on diet and exercise.
How long
32 to 56 weeks, some up to about 3 years
Source
Saxenda prescribing information on DailyMed . FDA label revised February 2026.

SaxendaFDA-approved product

Saxenda trial in teens with obesity

Row in the source: Pain where the shot was given

Placebo3.2%
On Saxenda3.2%
Who was studied
Children aged 12 and older with obesity. None had type 2 diabetes. 125 got Saxenda and 126 got placebo.
How long
56 weeks
Source
Saxenda prescribing information on DailyMed . FDA label revised February 2026.

TymlosFDA-approved product

Men with osteoporosis

Row in the source: Redness where the shot was given

Placebo5%
On Tymlos13%
Who was studied
Men aged 42 to 85. 149 men got Tymlos and 79 got placebo.
How long
12 months
Source
Tymlos prescribing information on DailyMed . FDA label revised August 2026.

TymlosFDA-approved product

Men with osteoporosis

Row in the source: Swelling where the shot was given

Placebo0%
On Tymlos7%
Who was studied
Men aged 42 to 85. 149 men got Tymlos and 79 got placebo.
How long
12 months
Source
Tymlos prescribing information on DailyMed . FDA label revised August 2026.

TymlosFDA-approved product

Men with osteoporosis

Row in the source: Pain where the shot was given

Placebo0%
On Tymlos6%
Who was studied
Men aged 42 to 85. 149 men got Tymlos and 79 got placebo.
How long
12 months
Source
Tymlos prescribing information on DailyMed . FDA label revised August 2026.

VyleesiFDA-approved product

Premenopausal women with HSDD

Row in the source: Reactions where the shot was given

Placebo8.4%
On Vyleesi13.2%
Who was studied
1,247 women aged 19 to 56 in two matching trials. 627 got Vyleesi and 620 got placebo.
How long
24 weeks
Source
Vyleesi prescribing information on DailyMed . FDA label revised March 2024.

ZepboundFDA-approved product

Zepbound trials in adults with obesity or overweight

Row in the source: Shot-site reactions, like redness, itching, or bruising

Placebo2%
On Zepbound (by dose)6% to 8%
Who was studied
Adults with obesity or overweight in 2 trials. One trial included only people with type 2 diabetes; the other left them out. 2,519 got Zepbound in three dose groups and 958 got placebo.
How long
Up to 72 weeks
Source
Zepbound prescribing information on DailyMed . FDA label revised August 2026.

Medicines that are not FDA-approved

CagrilintideNo FDA-approved product

Phase 2 weight trial (NCT03856047)

Row in the source: Redness where the shot was given

Placebo0%
On cagrilintide (by dose)4.0% to 16.8%
Who was studied
706 adults without diabetes who had obesity, or overweight with high blood pressure or unhealthy blood-fat levels. 506 got cagrilintide and 101 got placebo. A liraglutide group of 99 is not shown.
How long
26 weeks of treatment, side effects counted to week 32
Source
ClinicalTrials.gov posted results . Trial registry results posted July 18, 2023.

CagrilintideNo FDA-approved product

Phase 2 weight trial (NCT03856047)

Row in the source: Reactions where the shot was given

Placebo0%
On cagrilintide (by dose)4.0% to 11.8%
Who was studied
706 adults without diabetes who had obesity, or overweight with high blood pressure or unhealthy blood-fat levels. 506 got cagrilintide and 101 got placebo. A liraglutide group of 99 is not shown.
How long
26 weeks of treatment, side effects counted to week 32
Source
ClinicalTrials.gov posted results . Trial registry results posted July 18, 2023.

CagrilintideNo FDA-approved product

Phase 2 weight trial (NCT03856047), less common problems

Row in the source: Itching where the shot was given

Placebo0%
On cagrilintide (by dose)2.0% to 6.9%
Who was studied
706 adults without diabetes who had obesity, or overweight with high blood pressure or unhealthy blood-fat levels. 506 got cagrilintide and 101 got placebo. A liraglutide group of 99 is not shown.
How long
26 weeks of treatment, side effects counted to week 32
Source
ClinicalTrials.gov posted results . Trial registry results posted July 18, 2023.

CagrilintideNo FDA-approved product

Phase 2 weight trial (NCT03856047), less common problems

Row in the source: Rash where the shot was given

Placebo0%
On cagrilintide (by dose)0% to 5.9%
Who was studied
706 adults without diabetes who had obesity, or overweight with high blood pressure or unhealthy blood-fat levels. 506 got cagrilintide and 101 got placebo. A liraglutide group of 99 is not shown.
How long
26 weeks of treatment, side effects counted to week 32
Source
ClinicalTrials.gov posted results . Trial registry results posted July 18, 2023.

More from the labels

These lines are copied from our side effect pages, word for word.

Tymlos: Reactions where the shot was given

In the first month of the women's trial, shot sites were checked one hour after each shot. Redness was seen in 58% of women on Tymlos and 28% on placebo. Swelling was seen in 11% and 3%, and pain in 10% and 7%.

From Tymlos prescribing information on DailyMed .

Egrifta: Allergic and shot-site reactions

The warnings section gives a higher count of shot-site problems than the table: 25% of people on Egrifta and 14% on placebo.

From Egrifta WR prescribing information on DailyMed .

Mounjaro and Zepbound: Allergic and shot-site reactions

In the Mounjaro diabetes trials, allergic reactions were reported by 3.2% on Mounjaro and 1.7% on placebo. Some were severe, such as hives and eczema. Shot-site reactions were reported by 3.2% on Mounjaro and 0.4% on placebo.

Some people make antibodies to tirzepatide. In the Zepbound weight trials, shot-site reactions were reported by 11.3% of people on Zepbound who made these antibodies and 1% of those who did not.

From Mounjaro prescribing information on DailyMed  and Zepbound prescribing information on DailyMed .

How long were people watched?

Each bar is one set of trials. The dots on this page come only from the time inside each bar.

Stated length Range in the source Some people only

  1. Egrifta, adults with HIV26 weeks

  2. Saxenda, adults32 to 56 weeks, some up to about 3 years

  3. Saxenda, teens56 weeks

  4. Tymlos, men12 months

  5. Vyleesi, women24 weeks

  6. Zepbound, adultsUp to 72 weeks

  7. Cagrilintide, phase 226 weeks of treatment, side effects counted to week 32

Trials can miss rare harms and harms that take years to appear.

Other side effects

Pick a medicine and side effect

Where the numbers come from

Every number is copied from a table on our side effect pages. Those tables come from FDA labels on DailyMed, results posted on ClinicalTrials.gov, and company trial results. We did not add, total, or rank any number. Rows keep one fixed order: FDA-approved medicines first, then the rest, each in A to Z order.

We group rows by name. For example, “Tiredness (fatigue)” and “Tiredness or weakness (fatigue)” are both under tiredness. Each row still shows its own words from the source.

The tables on this site copy part of each label, such as the most common problems. A problem missing from one table may still have happened.

Report a side effect

You can report a suspected side effect to the FDA at 1-800-FDA-1088 or through FDA MedWatch . If a reaction feels serious, get medical care first.

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