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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.

NEFOPAM: 2,857 Adverse Event Reports & Safety Profile

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2,857
Total FAERS Reports
360 (12.6%)
Deaths Reported
1,685
Hospitalizations
2,857
As Primary/Secondary Suspect
345
Life-Threatening
17
Disabilities

Active Ingredient: NEFOPAM HYDROCHLORIDE ·

First Report: 20001117 · Latest Report: 20250903

What Are the Most Common NEFOPAM Side Effects?

#1 Most Reported
Cholestasis
135 reports (4.7%)
#2 Most Reported
Confusional state
134 reports (4.7%)
#3 Most Reported
Acute kidney injury
130 reports (4.6%)

All NEFOPAM Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Cholestasis 135 4.7% 2 72
Confusional state 134 4.7% 4 90
Acute kidney injury 130 4.6% 44 102
Hepatocellular injury 107 3.8% 1 69
Hepatic cytolysis 101 3.5% 0 72
Eosinophilia 97 3.4% 23 76
Rash maculo-papular 97 3.4% 23 67
Drug reaction with eosinophilia and systemic symptoms 90 3.2% 10 62
Coma 86 3.0% 4 50
Somnolence 84 2.9% 0 76
Agranulocytosis 77 2.7% 0 75
Hypotension 77 2.7% 10 50
Acute generalised exanthematous pustulosis 75 2.6% 1 59
Toxicity to various agents 69 2.4% 31 37
Death 67 2.4% 67 36
Dyspnoea 65 2.3% 28 43
Drug abuse 59 2.1% 10 19
Anaphylactic shock 58 2.0% 0 16
Fall 56 2.0% 9 41
Thrombocytopenia 56 2.0% 25 46

Who Reports NEFOPAM Side Effects? Age & Gender Data

Gender: 54.4% female, 45.6% male. Average age: 55.0 years. Most reports from: FR. View detailed demographics →

Is NEFOPAM Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 4 0 0
2001 1 0 1
2002 1 0 1
2003 4 0 4
2005 1 0 1
2006 3 0 3
2007 5 0 5
2008 3 1 2
2009 4 0 2
2010 11 0 11
2011 11 0 8
2012 8 1 2
2013 31 3 20
2014 72 5 54
2015 112 7 94
2016 111 24 91
2017 298 35 220
2018 271 32 147
2019 247 19 162
2020 174 35 84
2021 231 40 118
2022 222 22 98
2023 353 18 209
2024 202 19 117
2025 138 32 80

View full timeline →

What Is NEFOPAM Used For?

IndicationReports
Pain 1,107
Product used for unknown indication 614
Analgesic therapy 115
Procedural pain 94
Analgesic intervention supportive therapy 81
Pain prophylaxis 61
Anaesthesia 54
Back pain 52
Postoperative analgesia 46
Gait disturbance 45

NEFOPAM vs Alternatives: Which Is Safer?

NEFOPAM vs NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN ANTIGEN\NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN ANTIGEN\NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN ANTIGEN\NEISSERIA MENINGITIDIS GROUP B STRAIN NZ98/254 OUTER MEMBRANE VESICLE\NEISSERIA MENINGITIDIS SEROGROUP B FHBP FUSION PROTEIN ANTIG NEFOPAM vs NELARABINE NEFOPAM vs NELFINAVIR NEFOPAM vs NELVUTAMIG NEFOPAM vs NEMOLIZUMAB NEFOPAM vs NEMOLIZUMAB-ILTO NEFOPAM vs NEOMYCIN NEFOPAM vs NEORAL NEFOPAM vs NEOSTIGMINE NEFOPAM vs NEOSTIGMINE METHYLSULFATE

Official FDA Label for NEFOPAM

Official prescribing information from the FDA-approved drug label.