GUANIDINE: 81 Adverse Event Reports & Safety Profile

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Total FAERS Reports

32 (39.5%)

Deaths Reported

Hospitalizations

As Primary/Secondary Suspect

Life-Threatening

Disabilities

Approved Prior to Jan 1, 1982

FDA Approved

Discontinued

Status

FDA Application: 001546 ·

First Report: 1970 · Latest Report: 20220101

What Are the Most Common GUANIDINE Side Effects?

#1 Most Reported

Rash

76 reports (93.8%)

#2 Most Reported

Pulmonary pain

76 reports (93.8%)

#3 Most Reported

Lower respiratory tract infection

76 reports (93.8%)

Side Effect	Reports	% of Total	Deaths	Hosp.
Abdominal discomfort	76	93.8%	32	74
Arthropathy	76	93.8%	32	74
Lower respiratory tract infection	76	93.8%	32	74
Pulmonary pain	76	93.8%	32	74
Rash	76	93.8%	32	74
Product dose omission issue	75	92.6%	32	73
Off label use	74	91.4%	32	72
Drug abuse	72	88.9%	29	71
Intentional product misuse	72	88.9%	28	71
Overdose	72	88.9%	29	71
Knee arthroplasty	58	71.6%	23	56
Obesity	38	46.9%	0	38
Amyloid arthropathy	35	43.2%	0	35
Condition aggravated	32	39.5%	31	30
Covid-19	32	39.5%	32	30
Lung neoplasm malignant	32	39.5%	32	30
Radiation inflammation	32	39.5%	32	30
Inflammation	31	38.3%	31	29
Schizophrenia	28	34.6%	28	26
Feeling abnormal	15	18.5%	12	15

Gender: 77.9% female, 22.1% male. Average age: 65.7 years. Most reports from: GB. View detailed demographics →

Year	Reports	Deaths	Hosp.
2018	1	0	1
2019	16	12	16
2020	58	20	56
2021	2	0	2
2022	1	0	0

Indication	Reports
Abdominal discomfort	57
Depression	57
Product used for unknown indication	28

Official prescribing information from the FDA-approved drug label.