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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

METARAMINOL: 165 Adverse Event Reports & Safety Profile

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165
Total FAERS Reports
27 (16.4%)
Deaths Reported
41
Hospitalizations
165
As Primary/Secondary Suspect
27
Life-Threatening
1
Disabilities
Approved Prior to Jan 1, 1982
FDA Approved
Discontinued
Status
Yes
Generic Available

FDA Application: 009509 ·

First Report: 20100510 · Latest Report: 20250701

What Are the Most Common METARAMINOL Side Effects?

#1 Most Reported
Condition aggravated
40 reports (24.2%)
#2 Most Reported
Respiratory failure
37 reports (22.4%)
#3 Most Reported
Drug ineffective
23 reports (13.9%)

All METARAMINOL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Condition aggravated 40 24.2% 21 6
Respiratory failure 37 22.4% 21 4
Drug ineffective 23 13.9% 3 9
Hypotension 19 11.5% 2 14
Anaphylactic reaction 15 9.1% 1 8
Maternal exposure during pregnancy 12 7.3% 0 5
Confusion postoperative 11 6.7% 0 0
Foetal exposure during pregnancy 11 6.7% 0 0
Mental status changes postoperative 11 6.7% 0 0
Metabolic alkalosis 11 6.7% 0 0
Rash 11 6.7% 0 4
Unevaluable event 11 6.7% 0 0
Lip swelling 10 6.1% 0 4
Cardiac arrest 9 5.5% 1 3
Hyperglycaemia 8 4.9% 0 1
Metabolic acidosis 8 4.9% 0 5
Premature baby 8 4.9% 0 0
Blood pressure decreased 7 4.2% 0 1
Angioedema 6 3.6% 0 0
Bronchospasm 6 3.6% 0 1

Who Reports METARAMINOL Side Effects? Age & Gender Data

Gender: 55.3% female, 44.7% male. Average age: 56.4 years. Most reports from: AU. View detailed demographics →

Is METARAMINOL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2010 1 0 0
2014 2 0 0
2015 11 0 0
2016 13 0 2
2017 1 0 0
2018 5 0 0
2019 3 0 0
2021 2 1 0
2022 4 0 4
2023 19 18 5
2024 3 0 2
2025 5 0 0

View full timeline →

What Is METARAMINOL Used For?

IndicationReports
Product used for unknown indication 99
Hypotension 11
General anaesthesia 6

METARAMINOL vs Alternatives: Which Is Safer?

METARAMINOL vs METAXALONE METARAMINOL vs METFORMIN METARAMINOL vs METFORMIN\PIOGLITAZONE METARAMINOL vs METFORMIN\ROSIGLITAZONE METARAMINOL vs METFORMIN\SAXAGLIPTIN METARAMINOL vs METFORMIN\SITAGLIPTIN METARAMINOL vs METFORMIN\VILDAGLIPTIN METARAMINOL vs METHADONE METARAMINOL vs METHAMPHETAMINE METARAMINOL vs METHENAMINE HIPPURATE

Official FDA Label for METARAMINOL

Official prescribing information from the FDA-approved drug label.