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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.

COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE: 185 Adverse Event Reports & Safety Profile

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185
Total FAERS Reports
17 (9.2%)
Deaths Reported
136
Hospitalizations
185
As Primary/Secondary Suspect
11
Life-Threatening
2
Disabilities

First Report: 2014 · Latest Report: 20250201

What Are the Most Common COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE Side Effects?

#1 Most Reported
Diarrhoea
53 reports (28.6%)
#2 Most Reported
Acute kidney injury
49 reports (26.5%)
#3 Most Reported
Drug reaction with eosinophilia and systemic symptoms
15 reports (8.1%)

All COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Diarrhoea 53 28.7% 1 50
Acute kidney injury 49 26.5% 10 38
Drug reaction with eosinophilia and systemic symptoms 15 8.1% 0 14
Vomiting 13 7.0% 0 12
Pancytopenia 12 6.5% 9 3
Nausea 11 6.0% 0 10
Metabolic acidosis 10 5.4% 10 1
Pruritus 10 5.4% 0 6
Accidental overdose 9 4.9% 9 0
Hepatocellular injury 9 4.9% 1 8
Rash maculo-papular 8 4.3% 0 8
Rhabdomyolysis 8 4.3% 0 8
Hypokalaemia 7 3.8% 0 7
Lactic acidosis 7 3.8% 0 7
Rash 7 3.8% 0 7
Renal failure 7 3.8% 1 6
Hypocalcaemia 6 3.2% 0 6
Hypomagnesaemia 6 3.2% 0 6
Oligoasthenozoospermia 6 3.2% 0 0
Abdominal pain 5 2.7% 0 0

Who Reports COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE Side Effects? Age & Gender Data

Gender: 39.8% female, 60.2% male. Average age: 68.3 years. Most reports from: FR. View detailed demographics →

Is COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 5 1 2
2015 5 0 5
2016 4 1 4
2017 21 0 18
2018 27 0 24
2019 61 9 37
2020 19 0 18
2021 20 5 10
2022 9 0 9
2023 7 0 6
2024 2 0 2
2025 1 0 0

View full timeline →

What Is COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE Used For?

IndicationReports
Gout 94
Product used for unknown indication 21
Pericarditis 15
Arthralgia 9
Gouty arthritis 7
Hyperuricaemia 6
Arthritis 5
Chondrocalcinosis 5

COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE vs Alternatives: Which Is Safer?

COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE vs COLESEVELAM COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE vs COLESTIPOL COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE vs COLISTIMETHATE COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE vs COLISTIN COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE vs COLLAGENASE CLOSTRIDIUM HISTOLYTICUM COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE vs COLLAGENASE CLOSTRIDIUM HISTOLYTICUM-AAES COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE vs COMBIVENT COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE vs COMBIVIR COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE vs COMETRIQ COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE vs CONCERTA

Official FDA Label for COLCHICINE\OPIUM\TIEMONIUM METHYLSULFATE

Official prescribing information from the FDA-approved drug label.