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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.

PLACEBO: 312 Adverse Event Reports & Safety Profile

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312
Total FAERS Reports
30 (9.6%)
Deaths Reported
223
Hospitalizations
312
As Primary/Secondary Suspect
22
Life-Threatening
4
Disabilities

First Report: 200211 · Latest Report: 20250121

What Are the Most Common PLACEBO Side Effects?

#1 Most Reported
Nausea
18 reports (5.8%)
#2 Most Reported
Sexual dysfunction
15 reports (4.8%)
#3 Most Reported
Blood prolactin abnormal
15 reports (4.8%)

All PLACEBO Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Nausea 18 5.8% 0 16
Blood prolactin abnormal 15 4.8% 4 6
Sexual dysfunction 15 4.8% 4 6
Pneumonia 14 4.5% 4 10
Sedation 13 4.2% 4 6
Dyskinesia 12 3.9% 4 6
Dystonia 12 3.9% 4 6
Vomiting 12 3.9% 0 11
Cardiac failure 11 3.5% 3 8
Dizziness 11 3.5% 0 10
Anaemia 10 3.2% 0 10
Drug ineffective 10 3.2% 4 1
Headache 10 3.2% 0 8
Insurance issue 10 3.2% 2 6
Akathisia 9 2.9% 0 6
Blood glucose increased 9 2.9% 4 2
Schizophrenia 9 2.9% 4 0
Suicide attempt 9 2.9% 3 0
Abdominal pain 8 2.6% 0 5
Basal cell carcinoma 8 2.6% 0 2

Who Reports PLACEBO Side Effects? Age & Gender Data

Gender: 61.8% female, 38.2% male. Average age: 59.9 years. Most reports from: US. View detailed demographics →

Is PLACEBO Getting Safer? Reports by Year

YearReportsDeathsHosp.
2002 1 0 1
2007 5 0 4
2008 5 0 4
2009 4 0 3
2010 8 1 6
2011 11 2 9
2012 33 3 28
2013 72 5 58
2014 50 2 39
2015 2 0 2
2016 19 0 15
2018 2 0 2
2019 7 0 6
2020 7 1 5
2021 7 2 6
2022 11 0 5
2023 6 0 6
2024 13 1 11
2025 1 0 1

View full timeline →

What Is PLACEBO Used For?

IndicationReports
Product used for unknown indication 16
Malignant melanoma 15
Rheumatoid arthritis 12
Breast cancer 11
Ovarian cancer 11
Type 2 diabetes mellitus 11
Hiv infection 10
Cardiovascular disorder 9
Her2 positive breast cancer 9
Non-small cell lung cancer metastatic 9

PLACEBO vs Alternatives: Which Is Safer?

PLACEBO vs PLAN B ONE-STEP PLACEBO vs PLANTAGO LANCEOLATA POLLEN PLACEBO vs PLANTAGO SEED PLACEBO vs PLATINUM PLACEBO vs PLAVIX PLACEBO vs PLECANATIDE PLACEBO vs PLERIXAFOR PLACEBO vs PNEUMOCOCCAL 13-VALENT CONJUGATE VACCINE PLACEBO vs PNEUMOCOCCAL 7-VALENT CONJUGATE VACCINE PLACEBO vs PNEUMOCOCCAL VACCINE POLYVALENT

Official FDA Label for PLACEBO

Official prescribing information from the FDA-approved drug label.