How many supplement adverse-event reports did the FDA receive from 2014 to 2024?

FDA's CAERS database holds 35,817 reports from 2014 through 2024 that name at least one dietary-supplement product (industry code 54), counted via the openFDA API. CAERS is voluntary, so this is a fraction of all adverse events.

What share of supplement reports are serious?

33.8% (12,113 reports) record death, a life-threatening event, hospitalization, disability or required intervention. Serious events are more likely to be reported than mild ones, so the share overstates severity across all supplement users.

Are supplement adverse-event reports increasing?

No. Reports peaked at 4,568 in 2016; 2024 had 2,809, 16.9% fewer than 2014. The serious share rose from 31.8% to 40.9% over the same period.

What is the most common supplement adverse reaction reported to the FDA?

Choking (3,448 reports), followed by nausea, diarrhoea and vomiting. Dysphagia and foreign body are also in the top 15, pointing to pills and capsules that are hard to swallow.

Supplement Adverse Events Reported to the FDA, 2014-2024: What CAERS Shows

Correction, 2026-09-26. An earlier version of this page reported 78,412 reports, a 40.1% serious-outcome rate, a 41.6% rise in reports and a 14-category breakdown. Those figures were modeled estimates, not counts from FDA data, and the page presented them as FDA counts. Every figure on this page is now computed directly from FDA's CAERS data through the openFDA API, with each query listed in the methodology. The real count is 35,817 reports, and report volume fell, rather than rose, over the decade. The dataset deposited earlier under DOI 10.5281/zenodo.20632389 contains the modeled figures; a corrected version will be issued.

Not medical advice

This study describes regulatory data, not medical guidance. CAERS reports are voluntary, capture only a fraction of real adverse events, and do not establish that a product caused the event. Talk to a doctor or pharmacist before starting or stopping any supplement.

Health Britannica is not affiliated with the FDA or with any product named below. A product appears here because it is named in public CAERS records, not because of a clinical judgement about it.

Key findings

35,817 CAERS reports from 2014 through 2024 name at least one dietary-supplement product (FDA industry code 54, "Vit/Min/Prot/Unconv Diet").
33.8% carry a serious outcome (12,113 reports): 8,110 hospitalization, 2,633 life-threatening, 2,048 disability, 873 death, 209 required intervention. A report can carry several.
Report volume fell over the decade. It peaked at 4,568 in 2016; 2024 had 2,809, 16.9% fewer than 2014.
The serious share rose from 31.8% of reports in 2014 to 40.9% in 2024, even as total volume fell.
Choking is the most-reported reaction (3,448 reports), with dysphagia (1,435) and foreign body (1,348) also in the top 15: a pill- and capsule-swallowing signal, not a pharmacological one.
The most-named products are mainstream: vitamin D, a prostate formula (Super Beta Prostate, 1,096 reports), multivitamins, fish oil and the PreserVision AREDS 2 eye formula. Volume tracks how widely a product is used as much as how risky it is.
Kratom appears in 695 reports (any product type), peaking at 183 in 2018.
CBD, cannabidiol or hemp products appear in 274 supplement-coded reports, peaking at 65 in 2019; starting from 2 in 2014, a growth percentage would be meaningless.
Weight-loss and sports products whose names match our keyword lists appear in at least 1,398 reports (3.9%) and 633 serious reports (5.2% of serious). These are lower bounds: products named only by brand are missed.

Reports per year, and the serious share

Source: FDA CAERS via openFDA, reports naming at least one code-54 supplement product, by date created. Red = reports with a serious outcome (death, life-threatening, hospitalization, disability, required intervention).

Year	Reports	Serious	Serious share	Death listed
2014	3,379	1,074	31.8%	60
2015	3,547	1,314	37.0%	52
2016	4,568	1,603	35.1%	80
2017	3,579	1,141	31.9%	70
2018	3,425	1,112	32.5%	165
2019	3,034	1,057	34.8%	86
2020	3,557	960	27.0%	38
2021	2,579	857	33.2%	57
2022	2,763	982	35.5%	73
2023	2,577	864	33.5%	94
2024	2,809	1,149	40.9%	98
2014-2024	35,817	12,113	33.8%	873

Volume peaked in 2016 and has run lower since. The serious share moved the other way, from 31.8% in 2014 to 40.9% in 2024. One plausible reading is that reporting increasingly comes from serious cases (hospitals, poison centres, clinicians) while milder consumer reports taper off, but CAERS alone cannot tell the two apart.

What the serious outcomes are

Reports carrying each outcome, 2014-2024. Outcomes overlap, so these do not sum to the 12,113 serious reports. CAERS also has a broad "Other Serious or Important Medical Event" code (22,655 reports) that we do not count as serious, because it is a catch-all rather than a defined outcome.

The most-reported reactions

Choking leads by a clear margin, and dysphagia (difficulty swallowing) and foreign body sit in the same top 15. Large tablets and capsules, not only active ingredients, show up in the safety record.

#	Reaction (MedDRA term)	Reports
1	Choking	3,448
2	Nausea	2,970
3	Diarrhoea	2,821
4	Vomiting	2,787
5	Dyspnoea	2,278
6	Dizziness	1,982
7	Headache	1,801
8	Abdominal pain upper	1,714
9	Hypersensitivity	1,649
10	Pruritus	1,494
11	Malaise	1,458
12	Dysphagia	1,435
13	Blood pressure increased	1,422
14	Pain	1,389
15	Foreign body	1,348

openFDA returns spelling and case variants (for example "Choking" and "CHOKING") as separate terms; we merged them case-insensitively from the top 100 rows.

The most-named products

The products named most often are among the most widely used: vitamin D, multivitamins, fish oil, calcium. A high count reflects how many people take a product as much as how risky it is, so this is not a danger ranking.

#	Product name as reported	Reports
1	vitamin d	1,596
2	SUPER BETA PROSTATE	1,096
3	multivitamin	1,026
4	Fish oil	868
5	vitamin C	859
6	PRESERVISION AREDS 2	806
7	calcium	799
8	magnesium	633
9	Vitamin D3	592
10	Biotin	456
11	Redacted by FDA ("Exemption 4", confidential commercial information)	396
12	CITRACAL MAXIMUM	379

CBD, kratom and melatonin over time

These three come up often in supplement-safety coverage. Counts come from product-name matching and are lower bounds; kratom is counted across all product types because it is often not coded as a supplement.

Year	CBD / cannabidiol / hemp (supplement-coded)	Kratom (any product type)	Melatonin (supplement-coded)
2014	2	6	38
2015	1	5	45
2016	1	20	41
2017	6	29	47
2018	18	183	45
2019	65	93	48
2020	43	42	64
2021	43	78	49
2022	42	64	60
2023	28	82	65
2024	25	93	43
Total	274	695	545

Methodology

Source. FDA's CAERS data through the openFDA food adverse-event API, last refreshed by FDA on 2026-07-07. We queried it on 2026-09-26.

Counting unit. CAERS report listing at least one product with FDA industry code 54, date_created 2014-01-01 to 2024-12-31. FDA's own industry list confirms code 54 as "Vit/Min/Prot/Unconv Diet(Human/Animal)" with 35,817 reports in range. openFDA search is not nested, so the supplement product is not necessarily the one suspected in the report.

Serious. At least one outcome of: Death, Life Threatening, Hospitalization, Disability, Required Intervention. "Congenital Anomaly" (56 reports) and the catch-all "Other Serious or Important Medical Event" are not included.

Keyword groups. Weight-loss: hydroxycut, garcinia, "weight loss", slim, slimming, "fat burner", fatburner, lipozene, thermogenic, "green coffee", keto, phentermine, sibutramine, "raspberry ketone". Sports: "pre workout", preworkout, "pre-workout", creatine, whey, bcaa, "mass gainer", sarm, sarms, testosterone, "test booster", bodybuilding, anabolic. Matched against product names only, so every keyword figure is a lower bound.

Reproduce it. The headline queries:

Total: https://api.fda.gov/food/event.json?search=products.industry_code:54+AND+date_created:[20140101+TO+20241231]&limit=1
Serious: https://api.fda.gov/food/event.json?search=products.industry_code:54+AND+date_created:[20140101+TO+20241231]+AND+outcomes.exact:(%22Death%22+OR+%22Life+Threatening%22+OR+%22Hospitalization%22+OR+%22Disability%22+OR+%22Required+Intervention%22)&limit=1
Per year: https://api.fda.gov/food/event.json?search=products.industry_code:54+AND+date_created:[20140101+TO+20241231]&count=date_created
Outcomes: https://api.fda.gov/food/event.json?search=products.industry_code:54+AND+date_created:[20140101+TO+20241231]&count=outcomes.exact

All 20 queries, and every number on this page, are in data.json.

Limitations

Underreporting. CAERS is voluntary and captures only a fraction of adverse events; counts describe what was reported, not how often harm happens.
No causation. A report records that an event followed use of a product. Other medicines, conditions and misuse are not ruled out.
Reporting bias. Serious events are more likely to be reported, so the 33.8% serious share overstates severity across all supplement users.
Product coding. Industry codes are assigned from what reporters write; some supplements are coded elsewhere and are not counted here.
Revisions. FDA updates CAERS; counts can shift slightly when openFDA refreshes.

Downloads

Free under CC-BY 4.0 with a link back to this page: reports per year (CSV), outcomes (CSV), and everything, with queries (JSON). The reports-per-year chart can be embedded with an iframe.

For industry and usage statistics, see 85 Supplement and Functional Medicine Statistics for 2026.