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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.

DROTAVERINE: 175 Adverse Event Reports & Safety Profile

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175
Total FAERS Reports
21 (12.0%)
Deaths Reported
116
Hospitalizations
175
As Primary/Secondary Suspect
62
Life-Threatening
13
Disabilities

Active Ingredient: DROTAVERINE HYDROCHLORIDE ·

First Report: 20110121 · Latest Report: 20240423

What Are the Most Common DROTAVERINE Side Effects?

#1 Most Reported
Toxicity to various agents
54 reports (30.9%)
#2 Most Reported
Drug interaction
48 reports (27.4%)
#3 Most Reported
Pain
45 reports (25.7%)

All DROTAVERINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Toxicity to various agents 54 30.9% 0 41
Drug interaction 48 27.4% 0 46
Pain 45 25.7% 6 44
Constipation 39 22.3% 6 38
Balance disorder 38 21.7% 0 37
Hypotension 38 21.7% 0 37
Off label use 36 20.6% 2 32
Cognitive disorder 35 20.0% 0 34
Dyspnoea 35 20.0% 0 32
Fall 34 19.4% 0 33
Sedation complication 34 19.4% 0 33
Blood calcium decreased 33 18.9% 0 32
Creatinine renal clearance decreased 33 18.9% 0 32
Depressed level of consciousness 33 18.9% 0 32
Mobility decreased 33 18.9% 0 32
Orthostatic hypotension 33 18.9% 0 32
Overdose 33 18.9% 4 28
Renal function test abnormal 33 18.9% 0 32
Sedation 33 18.9% 0 32
Drug abuse 32 18.3% 0 28

Who Reports DROTAVERINE Side Effects? Age & Gender Data

Gender: 70.5% female, 29.5% male. Average age: 48.5 years. Most reports from: PL. View detailed demographics →

Is DROTAVERINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2011 1 0 1
2013 1 0 1
2014 2 0 0
2016 1 0 1
2017 4 3 1
2019 9 7 8
2020 18 0 2
2021 5 0 5
2022 2 1 1
2023 7 0 3
2024 5 3 5

View full timeline →

What Is DROTAVERINE Used For?

IndicationReports
Product used for unknown indication 107
Abdominal pain 10
Suicide attempt 9
Abdominal pain upper 7
Pain 6

DROTAVERINE vs Alternatives: Which Is Safer?

DROTAVERINE vs DROXIDOPA DROTAVERINE vs DULAGLUTIDE DROTAVERINE vs DULERA DROTAVERINE vs DULOXETINE DROTAVERINE vs DUPILUMAB DROTAVERINE vs DURAGESIC DROTAVERINE vs DUROGESIC DROTAVERINE vs DUROTEP MT DROTAVERINE vs DURVALUMAB DROTAVERINE vs DUTASTERIDE

Official FDA Label for DROTAVERINE

Official prescribing information from the FDA-approved drug label.