Adverse Event Profile: Omega 3

Source: FDA Center for Food Safety and Applied Nutrition (CFSAN) Adverse Event Reporting System Total Events: 309 Serious Events: 115 Date Range: 20071128 to 20250909

Top Reported Reactions

Nausea: 24
Diarrhoea: 22
CHOKING: 15
NAUSEA: 14
Vomiting: 14
DYSPNOEA: 13
Headache: 13
HYPERSENSITIVITY: 12
DIARRHOEA: 12
Abdominal pain: 12
DIZZINESS: 12
DYSPHAGIA: 11
Pain: 11
Blood pressure increased: 11
Pruritus: 11
Dizziness: 11
Abdominal discomfort: 11
Dyspnoea: 10
Alopecia: 10
DECREASED APPETITE: 9

Outcomes

Other Serious or Important Medical Event: 205
Hospitalization: 69
Visited a Health Care Provider: 64
Visited Emergency Room: 56
Other Serious Outcome: 27
Disability: 25
Other Outcome: 24
Life Threatening: 19
Required Intervention: 4
Allergic Reaction: 4

Products Involved (179 unique)

ABH NATURE ORGANIC ASHWAGANDHA ROOT POWDER
ABS DAILY NUTRIENT PROGRAM NORWEGIAN FISH OIL
ABS OMEGA Q PLUS
ALGAE DHA (SPECTRUM)
ARBONNE PHYTOSPORT PREPARE & ENDURE
ARCTIC WONDER SOFT GELS (OMEGA-3 TRIGLYCERIDES)
ARTRI KING ORTEGA OMEGA 3
ASHWAGANDHA
ASHWAGANDHA EXTRACT
ASQUARED NUTRITION PURE OMEGA 3 FISH OIL
Algae Omega-3
Animal Omega
Ashwagandha
BEST FORMULATIONS CLARY SAGE OMEGA 3 CO-Q10
BEVERLY HILLS MD DERMAL REPAID COMPLEX
BIO SCHWARTZ OMEGA3 FISH OIL
BIOSCHWARTZ ICELANDIC ULTRA PURE OMEGA 3 FISH OIL
BIOSCHWARTZ OMEGA 3 FISH OIL
CENTRUM DUAL ACTION MULTI PLUS OMEGA 3 MULTIGUMMIE
CENTRUM SPECIALIST PRENATAL (MULTIMINERALS, MULTIV

Disclaimer

This data is from the FDA CAERS database. A report does not mean the supplement caused the adverse event. Reports may be incomplete, duplicated, or unrelated. This is for safety awareness only.