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REPORTED SIGNALS

nicotinamide

Niacinamide

Registration status unknownSupplementlongevityAcella Pharmaceuticals, LLC
2,405
reports (FAERS)
93.8%
reported as serious
678
fatal reports (28.2%)
30
signals above threshold
2026-07
last updated
TIMELINE · FDA MILESTONES
Class II recall
2025
Class II recall
2025
2015
2026
SIGNAL RANKING · ROR

What stands out in the reports.

On the labelNew signalUnknown & frequent
Symptom
0.1110100
ROR [95% CI]
Pemphigus
275.2 [244.6309.7]
Joint Range OF Motion Decreased
205.1 [180.6233.0]
Synovitis
154.6 [136.3175.3]
Glossodynia
129.8 [114.7146.8]
Irritable Bowel Syndrome
127.4 [112.3144.6]
Wound
106.3 [94.0120.1]
Osteoarthritis
85.5 [76.395.7]
Night Sweats
82.9 [73.094.1]
Systemic Lupus Erythematosus
77.5 [68.387.9]
Infusion Related Reaction
70.6 [63.678.3]
Lower Respiratory Tract Infection
65.7 [58.174.2]
LUNG Disorder
63.3 [56.271.4]
Wheezing
50.4 [44.656.9]
Gastrooesophageal Reflux Disease
45.9 [41.051.3]
Dyspepsia
43.6 [39.248.5]

ROR = reporting odds ratio (log scale). A value above 1 means the symptom is reported more often for this product than for all other products combined. This measures how much it stands out in reports — not cause, not risk.

INTERPRETATION
Auto-generated

Nicotinamide reports show disproportionately high reporting for 'OFF LABEL USE', 'PAIN IN EXTREMITY', 'OSTEOARTHRITIS', 'NIGHT SWEATS', 'NAUSEA', 'SYSTEMIC LUPUS ERYTHEMATOSUS', 'INFUSION RELATED REACTION', and 'PYREXIA'. While nausea and pyrexia (fever) might relate to general drug reactions, the other signals like osteoarthritis or lupus are not directly linked to nicotinamide's known actions. This suggests these effects are reported more often than expected, but 'frequently reported' is not the same as 'frequently caused'. This does not replace medical advice.

This does not replace medical advice.

LABEL VERSUS REPORT
On the label

No signals currently mapped to the label.

Newly reported
Pemphigus
Joint Range OF Motion Decreased
Synovitis
Glossodynia
Irritable Bowel Syndrome
Wound
Osteoarthritis
Night Sweats
REPORTS OVER TIME

Report volume per quarter.

20182019202020212023
RECALL HISTORY · 30 ON RECORD
DateClassReasonFirm
Jul 18, 2025IILack of Processing Controls.AEQUITA PHARMACY
Jul 18, 2025IILack of Processing Controls.AEQUITA PHARMACY
Jul 18, 2025IILack of Processing Controls.AEQUITA PHARMACY
Jul 18, 2025IILack of Processing Controls.AEQUITA PHARMACY
Jul 18, 2025IILack of Processing Controls.AEQUITA PHARMACY
Jul 18, 2025IILack of Processing Controls.AEQUITA PHARMACY
Jul 18, 2025IILack of Processing Controls.AEQUITA PHARMACY
Nov 22, 2023IIPresence of Particulate Matter.AnazaoHealth Corporation
Dec 22, 2022IILack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.Pharmacy Innovations
Dec 22, 2022IILack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.Pharmacy Innovations
May 24, 2022IILack of Assurance of SterilityUS Specialty Formulations LLC
May 9, 2022IILack of assurance of sterility.Olympia Compounding Pharmacy dba Olympia Pharmacy
May 9, 2022IILack of assurance of sterility.Olympia Compounding Pharmacy dba Olympia Pharmacy
Jun 19, 2019IILack of Assurance of SterilityRXQ Compounding LLC
May 23, 2019IILack of Sterility Assurance.Pharm D Solutions, LLC
Dec 17, 2018IILack of sterility assurance.Promise Pharmacy, LLC
Dec 17, 2018IILack of sterility assurance.Promise Pharmacy, LLC
Dec 17, 2018IILack of sterility assurance.Promise Pharmacy, LLC
Dec 17, 2018IILack of sterility assurance.Promise Pharmacy, LLC
Feb 10, 2017IILack of Assurance of Sterility: There are also CGMP Deviations.Synergy Rx
Feb 10, 2017IILack of Assurance of Sterility: There are also CGMP Deviations.Synergy Rx
Feb 10, 2017IILack of Assurance of Sterility: There are also CGMP Deviations.Synergy Rx
Nov 17, 2016IILack of Assurance of SterilityTri-Coast Pharmacy
Nov 17, 2016IILack of Assurance of SterilityTri-Coast Pharmacy
Nov 17, 2016IILack of Assurance of SterilityTri-Coast Pharmacy
Nov 17, 2016IILack of Assurance of SterilityTri-Coast Pharmacy
Nov 17, 2016IILack of Assurance of SterilityTri-Coast Pharmacy
Nov 17, 2016IILack of Assurance of SterilityTri-Coast Pharmacy
Nov 17, 2016IILack of Assurance of SterilityTri-Coast Pharmacy
May 13, 2016IILack of Assurance of SterilityMedaus, Inc.

Class I = reasonable probability of serious harm · Class II = temporary or reversible · Class III = unlikely to cause harm. Source: openFDA enforcement.

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SOURCE & CITATION
HealthProves. nicotinamide — reported signals. Retrieved 2026-07-04. Source: openFDA (FAERS). healthproves.com/nicotinamide/
FAERS2,405 records
Retrieved2026-07-04
MethodROR / disproportionality