UNSPECIFIED INGREDIENT: 26,180 Adverse Event Reports & Safety Profile
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26,180
Total FAERS Reports
6,132 (23.4%)
Deaths Reported
11,236
Hospitalizations
26,180
As Primary/Secondary Suspect
1,596
Life-Threatening
793
Disabilities
First Report: 19660430 · Latest Report: 20250915
What Are the Most Common UNSPECIFIED INGREDIENT Side Effects?
#1 Most Reported
Death
2,090 reports (8.0%)
#2 Most Reported
Off label use
1,306 reports (5.0%)
#3 Most Reported
Drug ineffective
1,227 reports (4.7%)
All UNSPECIFIED INGREDIENT Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 2,090 | 8.0% | 2,089 | 308 |
| Off label use | 1,306 | 5.0% | 324 | 483 |
| Drug ineffective | 1,227 | 4.7% | 154 | 338 |
| Completed suicide | 1,190 | 4.6% | 1,189 | 170 |
| Nausea | 1,041 | 4.0% | 234 | 514 |
| Fatigue | 1,020 | 3.9% | 167 | 402 |
| Dyspnoea | 934 | 3.6% | 270 | 594 |
| Pneumonia | 903 | 3.5% | 310 | 719 |
| Asthenia | 894 | 3.4% | 237 | 506 |
| Vomiting | 877 | 3.4% | 244 | 528 |
| Diarrhoea | 821 | 3.1% | 152 | 457 |
| Pain | 701 | 2.7% | 128 | 299 |
| Dizziness | 692 | 2.6% | 88 | 283 |
| Headache | 681 | 2.6% | 125 | 261 |
| Pyrexia | 658 | 2.5% | 140 | 499 |
| Toxicity to various agents | 657 | 2.5% | 493 | 216 |
| Malaise | 642 | 2.5% | 84 | 310 |
| Anaemia | 586 | 2.2% | 149 | 435 |
| Abdominal pain | 568 | 2.2% | 226 | 401 |
| Drug hypersensitivity | 533 | 2.0% | 146 | 210 |
Who Reports UNSPECIFIED INGREDIENT Side Effects? Age & Gender Data
Gender: 53.1% female, 46.9% male. Average age: 55.6 years. Most reports from: US. View detailed demographics →
Is UNSPECIFIED INGREDIENT Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 17 | 1 | 8 |
| 2001 | 11 | 1 | 4 |
| 2002 | 25 | 3 | 13 |
| 2003 | 32 | 5 | 17 |
| 2004 | 49 | 7 | 25 |
| 2005 | 61 | 6 | 34 |
| 2006 | 81 | 8 | 48 |
| 2007 | 69 | 7 | 38 |
| 2008 | 123 | 21 | 70 |
| 2009 | 193 | 28 | 109 |
| 2010 | 269 | 37 | 145 |
| 2011 | 274 | 38 | 161 |
| 2012 | 455 | 51 | 227 |
| 2013 | 792 | 214 | 360 |
| 2014 | 1,575 | 219 | 867 |
| 2015 | 1,259 | 195 | 811 |
| 2016 | 1,188 | 216 | 677 |
| 2017 | 1,203 | 250 | 726 |
| 2018 | 1,289 | 298 | 754 |
| 2019 | 1,395 | 240 | 821 |
| 2020 | 1,355 | 335 | 768 |
| 2021 | 1,258 | 266 | 675 |
| 2022 | 1,128 | 222 | 591 |
| 2023 | 857 | 210 | 413 |
| 2024 | 625 | 158 | 316 |
| 2025 | 287 | 71 | 154 |
What Is UNSPECIFIED INGREDIENT Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 6,768 |
| Rheumatoid arthritis | 394 |
| Non-small cell lung cancer | 276 |
| Cardiac failure | 261 |
| Type 2 diabetes mellitus | 229 |
| Diffuse large b-cell lymphoma | 210 |
| Covid-19 | 207 |
| Malignant melanoma | 186 |
| Hiv infection | 185 |
| Suspected suicide | 172 |
UNSPECIFIED INGREDIENT vs Alternatives: Which Is Safer?
UNSPECIFIED INGREDIENT vs UPADACITINIB
UNSPECIFIED INGREDIENT vs URAPIDIL
UNSPECIFIED INGREDIENT vs UREA
UNSPECIFIED INGREDIENT vs URIDINE TRIACETATE
UNSPECIFIED INGREDIENT vs UROFOLLITROPIN
UNSPECIFIED INGREDIENT vs URSODIOL
UNSPECIFIED INGREDIENT vs USTEKINUMAB
UNSPECIFIED INGREDIENT vs USTEKINUMAB-STBA
UNSPECIFIED INGREDIENT vs VADADUSTAT
UNSPECIFIED INGREDIENT vs VALACYCLOVIR
Official FDA Label for UNSPECIFIED INGREDIENT
Official prescribing information from the FDA-approved drug label.