Ascorbic Acid

Summary

Ascorbic Acid (CHEMBL196) is an approved small-molecule flour treatment agent (ATC G01AD03) that acts as a supplement; approved for 6 indications including iron deficiency anemia and pneumonia, and in clinical trials for 57 other conditions.

At a glance

• Status: FDA-approved
• Modality: Small molecule
• ATC class: G01AD03 (+2 more)
• Targets: 2 (SLC23A1, SLC23A2)
• Indications: 104 conditions (top 1% of drugs corpus-wide)
• Clinical trials: 402
• Chemistry: C6H8O6
• Target biology: 2 curated targets implicated as cohort genes in 1 disease corpus-wide; indicated or in trials for 87 (0 on both)

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL196
Name	Ascorbic Acid
Type	Small molecule
Max phase	4
FDA approved	yes
ChEBI	CHEBI:29073
ATC	G01AD03, A11GA01, S01XA15
Molecular formula	C6H8O6
InChIKey	CIWBSHSKHKDKBQ-JLAZNSOCSA-N

SMILES: [H][C@]1([C@@H](O)CO)OC(=O)C(O)=C1O

ChEBI definition: The L-enantiomer of ascorbic acid and conjugate acid of L-ascorbate.

Pharmacological roles (ChEBI): coenzyme, flour treatment agent, cofactor, skin lightening agent, geroprotector.

Other ChEBI roles (chemical / environmental): food antioxidant, plant metabolite, food colour retention agent.

Also known as: Acide ascorbique, Acido ascorbico, Acidum ascorbicum, Ascoltin, Ascor, Ascorbate, Ascorbic acid, Ascorbic acid (vit c), Ascorbic acid component of moviprep, Ascorbic acid component of plenvu, Ascorbic acid component of vitaped, l-

Parent form; salt/anhydrous children: CHEMBL3350399

Patent coverage: ubiquitous in the patent literature (a reference / commodity compound named in millions of filings — the raw count carries no drug-specific signal).

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

Gene	Target	Action	pAffinity	Cancer dependency	UniProt
SLC23A1	Sodium-dependent vitamin C transporter 1	Binding			Q9UHI7
SLC23A2	Sodium-dependent vitamin C transporter 2			0%	Q9UGH3

Mechanism of action (ChEMBL curated)

Mechanism of action	Action type	Target	Target type
Supplement

Broader ChEMBL bioactivity targets: 5 (assay-derived screening hits — not curated targets; per-target potencies are in the ChEMBL bioactivities table below).

Bioactivity

ChEMBL activities: 4 potent at pChembl ≥ 5 of 7 total. Top 4 distinct by potency (10 = 0.1 nM, 6 = 1 µM):

Protein	UniProt	Gene	pChembl	Type	Value	Activity ID
Alpha-2B adrenergic receptor	P18089	ADRA2B	9.3	EC50	0.5 nM	CHEMBL_ACT_2408159
Prostaglandin G/H synthase 1	P23219	PTGS1	6.27	AC50	533.2 nM	CHEMBL_ACT_25205609
Prostaglandin G/H synthase 1	P23219	PTGS1	6.21	AC50	616.4 nM	CHEMBL_ACT_25206539
Urease (jack bean)	P07374		5.07	IC50	8590 nM	CHEMBL_ACT_24815645

Target pathways

Aggregated over 2 target gene(s): SLC23A1, SLC23A2.

Top Reactome pathways

4 total, by targets touching each:

Pathway	Targets	Genes
Metabolism	2	SLC23A1, SLC23A2
Vitamin C (ascorbate) metabolism	2	SLC23A1, SLC23A2
Metabolism of water-soluble vitamins and cofactors	2	SLC23A1, SLC23A2
Metabolism of vitamins and cofactors	2	SLC23A1, SLC23A2

Dominant GO biological processes

GO term	Targets
sodium ion transport	2
L-ascorbic acid transmembrane transport	2
L-ascorbic acid metabolic process	2
monoatomic ion transport	2
transmembrane transport	2
brain development	1
response to toxic substance	1
nucleobase transport	1
lung development	1
dehydroascorbic acid transport	1
urate transport	1
sodium ion transmembrane transport	1
response to oxidative stress	1
cell adhesion	1
cellular response to ethanol	1

Predicted targets — Sugi Predict

This molecule is SureChEMBL compound SCHEMBL11981759 — see its predicted protein targets + similar patent compounds on Sugi Predict.

Indications & clinical

Indications

6 approved indications. FDA phase 4.

Indication	Phase	MONDO	EFO
iron deficiency anemia	4	MONDO:0001356
pneumonia	4	MONDO:0005249	EFO:0003106
anemia	4	MONDO:0002280	EFO:0004272
chronic kidney disease	4	MONDO:0005300	EFO:0003884
eye disorder	4	MONDO:0005328	EFO:0003966
scurvy	4	MONDO:0009412	EFO:1001169

57 diseases in clinical trials (phase 2–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
diabetes mellitus	3	MONDO:0005015	EFO:0000400
colorectal adenocarcinoma	3	MONDO:0005008	EFO:0000365
atrial fibrillation	3	MONDO:0004981	EFO:0000275
uterine corpus leiomyoma	3	MONDO:0007886	EFO:0000731
heart failure	3	MONDO:0005252	EFO:0003144
atrial flutter	3	MONDO:0005310	EFO:0003911
colorectal neoplasm	3	MONDO:0005335	EFO:0004142
toxic shock syndrome	3	MONDO:0001881	EFO:0006834
myocardial ischemia	3	MONDO:0024644	EFO:1001375
macular degeneration	3	MONDO:0003004	EFO:0009606
complex regional pain syndrome	3	MONDO:0019369	EFO:1001998
gastric neoplasm	3	MONDO:0021085
severe acute respiratory syndrome	3	MONDO:0005091	EFO:0000694
respiratory tract infectious disorder	3	MONDO:0024355
influenza	3	MONDO:0005812	EFO:0007328
cataract	3	MONDO:0005129
coronary artery disorder	3	MONDO:0005010	EFO:0001645
paraganglioma	3	MONDO:0000448	EFO:1000453
non-Hodgkin lymphoma	2	MONDO:0018908	EFO:0005952
injury	2	MONDO:0021178	EFO:0000546
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
prostate adenocarcinoma	2	MONDO:0005082	EFO:0000673
exocrine pancreatic carcinoma	2	MONDO:0005192	EFO:0002618
metastatic prostate carcinoma	2	MONDO:0004956	EFO:0000196
myelodysplastic syndrome	2	MONDO:0018881	EFO:0000198
acute myeloid leukemia	2	MONDO:0018874	EFO:0000222
clear cell renal carcinoma	2	MONDO:0005005	EFO:0000349
epilepsy	2	MONDO:0005027	EFO:0000474
glioblastoma	2	MONDO:0018177	EFO:0000519
preeclampsia	2	MONDO:0005081	EFO:0000668
plasma cell myeloma	2	MONDO:0009693	EFO:0001378
muscle tissue disorder	2	MONDO:0003939	EFO:0002970
nicotine dependence	2	MONDO:0008575	EFO:0003768
pancreatic neoplasm	2	MONDO:0021040	EFO:0003860
stomatitis	2	MONDO:0004842	EFO:1001904
Hodgkins lymphoma	2	MONDO:0004952	EFO:0000183
myocardial infarction	2	MONDO:0005068	EFO:0000612
urinary tract infection	2	MONDO:0100338	EFO:0003103
heart disorder	2	MONDO:0005267	EFO:0003777
carotid artery disorder	2	MONDO:0005269	EFO:0003781
cardiac arrest	2	MONDO:0000745	EFO:0009492
cerebral atherosclerosis	2	MONDO:0006694	EFO:1000860
acute lung injury	2	MONDO:0015796	EFO:0004610
ovarian cancer	2	MONDO:0008170
acute promyelocytic leukemia	2	MONDO:0012883	EFO:0000224
rectal cancer	2	MONDO:0006519	EFO:1000657
depressive disorder	2	MONDO:0002050
viral infectious disease	2	MONDO:0005108	EFO:0000763
type 2 diabetes mellitus	2	MONDO:0005148
Charcot-Marie-Tooth disease	2	MONDO:0015626
beta thalassemia	2	MONDO:0019402
neuralgia	2	MONDO:0021667	EFO:0005762
lung neoplasm	2	MONDO:0021117
plasma cell neoplasm	2	MONDO:0004959	EFO:0000200
diffuse large B-cell lymphoma	2	MONDO:0018905	EFO:0000403
atherosclerosis	2	MONDO:0005311	EFO:0003914
vascular disorder	2	MONDO:0005385	EFO:0004264

17 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Regulatory approval & mechanism (DrugCentral)

Approved: FDA.

DrugCentral (CC BY-SA): authoritative regulatory-approval status + curated mechanism. The drug’s full target set is in Targets above.

Clinical trials

Total trials: 402.

Phase distribution

Phase	Trials
Not specified	136
Phase 2	84
Phase 4	46
Phase 3	44
Phase 1	41
Phase 1/2	21
Phase 2/3	17
Early Phase 1	13

Top trials by phase / activity

NCT	Phase	Status	Title
NCT07414693	Phase 4	RECRUITING	Effect of Vitamin C on Length of Hospital Stay in Children With Severe Pneumonia
NCT00140166	Phase 4	COMPLETED	Treatment of Acute Schizophrenia With Vitamin Therapy
NCT00303160	Phase 4	UNKNOWN	Effect of Helicobacter Pylori on the Availability of Vitamin E and C
NCT00356954	Phase 4	COMPLETED	NASPI: N-Acetylcysteine vs. Ascorbic Acid for Prevention of Contrast Induced Nephropathy in Renal Insufficiency Undergoing Coronary Catheterization
NCT00519337	Phase 4	COMPLETED	Impact of Ascorbic Acid on Post-Cardiothoracic Surgery Inflammation
NCT00869427	Phase 4	TERMINATED	Vitamin C for Prevention of Urinary Tract Infections in the Spinal Cord Injured
NCT01055418	Phase 4	COMPLETED	Cognitive and Cerebral Blood Flow Effects of Vitamin C
NCT01090895	Phase 4	UNKNOWN	Treatment of Reperfusion Event by Vitamin C Infusion
NCT01167569	Phase 4	COMPLETED	Study of High Dose Vitamin C On Outcome in Cardiac Surgery Patients
NCT01322061	Phase 4	COMPLETED	Vitamin C Efficacy in Reducing Post Operative Pain
NCT01332578	Phase 4	COMPLETED	A Comparison of Solid and Soluble Forms of Cold and Influenza Remedies
NCT01350102	Phase 4	TERMINATED	The Relationship of Hemoglobin A1c and Diabetic Wound Healing
NCT01356433	Phase 4	COMPLETED	Influence of Oral Vitamin C Supplement on the Inflammation Status in Dialysis Patients
NCT01558622	Phase 4	UNKNOWN	Intraoperative Use of Dexketoprofen Trometamol, Pethidine Hcl, Tramadol Hcl and Their Combinations for Postoperative Pain Management in Laparoscopic Nissen Fundoplication
NCT01595516	Phase 4	COMPLETED	Nebivolol and Endothelial Regulation of Fibrinolysis (NERF)
NCT01743742	Phase 4	COMPLETED	First-day High Dose Vitamin C, E in Severe Birth Asphyxia
NCT01865916	Phase 4	COMPLETED	2L Oral Bi-PegLyte Versus 2L Oral MoviPrep Regimen for Outpatient Colonic Preparation
NCT01926132	Phase 4	UNKNOWN	High-dose Ascorbic Acid Intravenous Injection Decreases Mitochondrial DNA Damage in Chronic Fatigue Patients: Randomized-controlled Study
NCT02019186	Phase 4	COMPLETED	Effects of Vitamin C and E on Endothelial Function in Adolescent Diabetes
NCT02209636	Phase 4	COMPLETED	Phosphate Lowering in CKD Trial
NCT02225886	Phase 4	UNKNOWN	Ascorbic Acid Administration in the Treatment of Anemia in Chronic Hemodialysed Patients
NCT02355197	Phase 4	COMPLETED	Antioxidants in Gestational Diabetes
NCT02455180	Phase 4	COMPLETED	Pharmacokinetics of Two Different High-dose Regimens of Intravenous Vitamin C in Critically Ill Patients
NCT02631668	Phase 4	COMPLETED	the Efficacy and Safety of Vitamin C for Iron Supplementation in Adult IDA Patients
NCT02639741	Phase 4	COMPLETED	Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia
NCT02780505	Phase 4	COMPLETED	Assessment of the Effect of Vitamin C on Anemia in Patients With Continuous Ambulatory Peritoneal Dialysis
NCT02956057	Phase 4	COMPLETED	Polyethylene Glycol Versus Low Volume Solutions Prior to Colonoscopy
NCT03049085	Phase 4	UNKNOWN	Effect of Preoperative Aspirin in Patients Undergoing Off-pump Coronary Artery Bypass Grafting
NCT03228238	Phase 4	TERMINATED	ANti-Oxidant in Variant Angina (ANOVA) Trial
NCT03252418	Phase 4	COMPLETED	Ascorbic Acid Versus Diode Laser in the Treatment of Gingival Hyperpigmentation
NCT03335124	Phase 4	TERMINATED	The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock
NCT03581149	Phase 4	UNKNOWN	Tolerability and Efficacy of Sodium Picosulfate/Magnesium Citrate Versus PEG/Ascorbic Acid in Ulcerative Colitis Patients
NCT03698474	Phase 4	COMPLETED	Comparison of Different Low Volume Solutions Prior to Colonoscopy
NCT03889158	Phase 4	TERMINATED	Effect of Age and Fitness on Vascular Function and Oxidative Stress During Acute Inflammation
NCT03921099	Phase 4	UNKNOWN	Impact of Ascorbic Acid in the Prevention of Vancomycin Induced Nephrotoxicty
NCT04135378	Phase 4	COMPLETED	Effect of Low Doses of Vitamin C on Salivary Cortisol , Heart Rate , Blood Pressure During Group Presentation
NCT04210453	Phase 4	UNKNOWN	The Impact of Vitamin C on Postoperative Acute Kidney Injury in Risk Patients Undergoing Valvular Heart Surgery
NCT04334967	Phase 4	SUSPENDED	Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care
NCT04468139	Phase 4	UNKNOWN	The Study of Quadruple Therapy Zinc, Quercetin, Bromelain and Vitamin C on the Clinical Outcomes of Patients Infected With COVID-19
NCT04472000	Phase 4	TERMINATED	Can Vitamin C Reduce the Risk of Postoperative Shoulder Stiffness?
NCT04598880	Phase 4	COMPLETED	Comparison of 1 Liter PEG With Ascorbate and Sodium Picosulfate / Magnesium Citrate for High Quality Colon Cleansing
NCT04756063	Phase 4	WITHDRAWN	Parenteral Ascorbic Acid Repletion in TransplantatIon
NCT05842395	Phase 4	COMPLETED	Vitamin c Supplementation in the Prevention of CRPS Following Distal Radius Fractures
NCT06152458	Phase 4	COMPLETED	Blessing or Curse? Combined Vitamin Therapy in Non Viral Septic Shock.
NCT06224881	Phase 4	COMPLETED	Vitamin C Deficiency in Septic Shock
NCT06384833	Phase 4	UNKNOWN	Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair
NCT02735707	Phase 3	RECRUITING	Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
NCT04268849	Phase 3	RECRUITING	Trial of IV vs Oral Iron Treatment of Iron Deficiency Anemia in the Post-Operative Bariatric Surgical Patient
NCT04516681	Phase 3	RECRUITING	Combination of IV Ascorbic Acid and Adebrelimab in Metastatic Colorectal Cancer
NCT07092618	Phase 2/3	RECRUITING	Effectiveness of Alternative Therapies in Maintaining Weight Loss Achieved by GLP-1 Medications Post-Cessation
NCT07476443	Phase 2/3	NOT_YET_RECRUITING	Renoprotective Role of Vitamin C and Coenzyme Q10 in Nephrotoxicity
NCT00000161	Phase 3	UNKNOWN	Randomized Trials of Vitamin Supplements and Eye Disease
NCT00000539	Phase 3	COMPLETED	Arterial Disease Multifactorial Intervention Trial (ADMIT)
NCT00000555	Phase 3	COMPLETED	Women’s Angiographic Vitamin and Estrogen Trial (WAVE)
NCT00231218	Phase 3	COMPLETED	Echinacea, Propolis and Vitamin C for URI Prevention in Preschoolers
NCT00272428	Phase 3	COMPLETED	Primary Prevention Trial of the Health Effects of Antioxidant Vitamins and Minerals.
NCT00387114	Phase 3	TERMINATED	Effect of an Anti-Oxidant Treatment on Resistin Serum Levels.A Randomized Study
NCT00515736	Phase 3	TERMINATED	Impact Of Antioxidant Micronutrients On Intensive Care Unit (ICU) Outcome
NCT00731926	Phase 2/3	COMPLETED	Effect of Antioxidant on Endurance Performance in Healthy Men
NCT00920413	Phase 3	COMPLETED	Oral Vitamin C for Correction of Anemia in Patients Receiving Peritoneal Dialysis
NCT00953212	Phase 3	COMPLETED	Prophylaxis to Reduce Postoperative Atrial Fibrillation in Cardiac Surgery
NCT01107730	Phase 3	COMPLETED	Vitamin C for Prophylaxis of Post-operative Atrial Fibrillation in On-pump Cardiac Surgery Procedures
NCT01125033	Phase 2/3	COMPLETED	Study of Vitamin C, Vitamin E and Their Combination to Treat Restless Legs Syndrome in Hemodialysis Patients
NCT01283646	Phase 3	COMPLETED	Efficacy and Tolerability of Apevitin BC Comparing to Vitamin Complex in Stimulating the Appetite
NCT01426490	Phase 2/3	UNKNOWN	The Effects of Vitamin B-6 Status on Homocysteine, Oxidative Stress, One-carbon Metabolism and Methylation: Cross-section, Case-control, Intervention and Follow-up Studies in Colorectal Cancer
NCT01501968	Phase 3	UNKNOWN	Efficacy of Ascorbic Acid for Prevention of Colistin-Associated Nephrotoxicity
NCT01580683	Phase 3	WITHDRAWN	Vitamin C and Atrial Fibrillation After Cardiac Surgery
NCT01715597	Phase 3	COMPLETED	Study on the Effect of Intravenous Ascorbic Acid on Intraoperative Blood Loss in Women With Uterine Myoma
NCT01723696	Phase 2/3	COMPLETED	Vitamin C to Decrease Effects of Smoking in Pregnancy on Infant Lung Function
NCT02083575	Phase 2/3	UNKNOWN	Role of Vitamin C to Augment Iron Chelation With DFP or DFX
NCT02390505	Phase 3	COMPLETED	Role of Vitamin C at 6 Months on Incidence of Complex Regional Pain Syndrome Type I in Upper Limb Surgery
NCT02678234	Phase 3	WITHDRAWN	An Efficacy and Safety Study of Theraflu Day Powder as Oral Solution for Cold and Flu
NCT02730364	Phase 3	WITHDRAWN	An Efficacy and Safety Study of Theraflu Night Powder as Oral Solution for Cold and Flu
NCT02745873	Phase 2/3	COMPLETED	Lead Detoxifying Effects of Ascorbic Acid Among School Going Adolescents of Karachi- A Cluster Randomized Control Trial
NCT02868151	Phase 2/3	COMPLETED	Effect of Oral Vitamin C in Assessing the Severity of Oral Mucositis in Chemoradiation of Head and Neck Cancers
NCT02942498	Phase 3	COMPLETED	Clinical Trial for Asses the Safety and Efficacy of Vitamin C and Vitamin E in Combination Versus Placebo for Treating Cognitive and Behavior Disorder in Children With Fragile X Syndrome
NCT02969681	Phase 3	COMPLETED	Vitamin C Intravenously With Chemotherapy in Advanced Colorectal Cancer
NCT03015675	Phase 3	UNKNOWN	IV Ascorbic Acid in Advanced Gastric Cancer
NCT03338569	Phase 2/3	COMPLETED	Vitamin C and Septic Shock
NCT03389555	Phase 2/3	COMPLETED	Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial
NCT03437902	Phase 2/3	COMPLETED	Impact of Rutin and Vitamin C Combination on Oxidative Stress, Insulin Sensitivity and Lipid Profile in Type 2 Diabetic Patients
NCT03509350	Phase 3	COMPLETED	Vitamin C, Thiamine, and Steroids in Sepsis
NCT03557229	Phase 3	UNKNOWN	Clinical Trial of Antioxidant Therapy in Patients With Septic Shock
NCT03680274	Phase 3	COMPLETED	Lessening Organ Dysfunction With VITamin C
NCT03828929	Phase 3	TERMINATED	Effect of IV Vitamin C, Thiamine, and Steroids on Mortality of Septic Shock
NCT03835286	Phase 3	WITHDRAWN	Vitamin C to Reduce Vasopressor Dose in Septic Shock
NCT03872011	Phase 3	COMPLETED	Vitamin C, Thiamine and Hydrocortisone for the Treatment of Septic Shock
NCT03965637	Phase 3	COMPLETED	Intravenous Ascorbic Acid Administration in Hysterectomy
NCT04088591	Phase 3	WITHDRAWN	High-dose Intravenous Vitamin C as an Adjunctive Treatment for Sepsis in Rwanda
NCT04138394	Phase 3	SUSPENDED	VItamin C in Thermal injuRY: The VICToRY Trial
NCT04197115	Phase 3	COMPLETED	Vitamin C, Thiamine, Cyanocobalamine, Pyridoxine and Hydrocortisone in Sepsis
NCT04328961	Phase 2/3	COMPLETED	Hydroxychloroquine for COVID-19 Post-exposure Prophylaxis (PEP)
NCT04354428	Phase 2/3	TERMINATED	Treatment for COVID-19 in High-Risk Adult Outpatients
NCT04401150	Phase 3	COMPLETED	Lessening Organ Dysfunction With VITamin C - COVID-19
NCT04404387	Phase 3	UNKNOWN	Lessening Organ Dysfunction With VITamin C in Septic ARDS
NCT04446104	Phase 3	COMPLETED	A Preventive Treatment for Migrant Workers at High-risk of COVID-19
NCT04747795	Phase 3	COMPLETED	Early Administration of Vitamin C in Patients With Sepsis or Septic Shock in Emergency Departments
NCT04780061	Phase 3	TERMINATED	Dietary Supplements for COVID-19
NCT04928495	Phase 3	UNKNOWN	Clinical Trial With N-acetylcysteine and Bromhexine for COVID-19
NCT05192213	Phase 3	TERMINATED	Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

MeSH pharmacological classification

Definition (MeSH): A six carbon compound related to glucose. It is found naturally in citrus fruits and many vegetables. Ascorbic acid is an essential nutrient in human diets, and necessary to maintain connective tissue and bone. Its biologically active form, vitamin C, functions as a reducing agent and coenzyme in several metabolic pathways. Vitamin C is considered an antioxidant.

Pharmacological action: Antioxidants; Vitamins.

Broader MeSH heading: Sugar Acids.

MeSH descriptor D001205 “Ascorbic Acid” — exact-name match.

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Adverse-event reports (FAERS)

114,658 reports across 8 FAERS drug-name records; 6,756 distinct MedDRA reactions.

openFDA FAERS — spontaneous post-marketing reports. Co-occurrence, not causation: reports are voluntary, unverified, and confounded by indication and reporting bias (the drug’s own indication often appears as a ‘reaction’). PRR is a disproportionality heuristic (reaction rate for this drug vs the FAERS background), NOT a risk estimate. Counts are pooled across the drug’s name records.

Most-reported events

Serious = reports flagged serious (death / life-threatening / hospitalisation / disability / other medically important).

50 reactions by report volume:

Reaction (MedDRA PT)	Reports	Serious	PRR
fatigue	13,410	8,978 (67%)	3.2×
pain	9,851	7,914 (80%)	3.0×
headache	9,764	6,831 (70%)	2.9×
nausea	9,700	6,710 (69%)	2.3×
diarrhoea	9,354	6,426 (69%)	2.7×
drug ineffective	9,126	5,991 (66%)	1.3×
off label use	8,986	6,932 (77%)	1.9×
dyspnoea	7,661	6,233 (81%)	2.5×
dizziness	6,996	4,896 (70%)	2.6×
arthralgia	6,962	5,310 (76%)	3.1×
rash	6,762	4,980 (74%)	2.9×
asthenia	6,623	5,311 (80%)	3.3×
vomiting	6,395	5,403 (84%)	2.5×
pruritus	5,521	3,542 (64%)	2.7×
insomnia	4,984	3,660 (73%)	3.5×
malaise	4,972	3,918 (79%)	2.1×
pyrexia	4,923	4,313 (88%)	2.6×
pain in extremity	4,868	3,676 (76%)	3.0×
fall	4,742	4,030 (85%)	2.6×
hypertension	4,641	4,265 (92%)	4.1×
pneumonia	4,635	4,548 (98%)	2.6×
joint swelling	4,504	4,073 (90%)	7.0×
weight increased	4,483	3,659 (82%)	3.7×
condition aggravated	4,403	3,636 (83%)	2.7×
nasopharyngitis	4,364	3,346 (77%)	4.5×
abdominal pain upper	4,360	3,577 (82%)	3.9×
peripheral swelling	4,323	3,588 (83%)	5.3×
weight decreased	4,168	3,288 (79%)	2.8×
constipation	4,152	2,959 (71%)	3.5×
decreased appetite	4,139	3,271 (79%)	3.3×
back pain	4,133	3,107 (75%)	3.3×
abdominal discomfort	4,127	3,293 (80%)	4.6×
rheumatoid arthritis	4,105	3,985 (97%)	6.8×
alopecia	4,069	3,125 (77%)	3.9×
hypersensitivity	3,936	3,442 (87%)	3.9×
drug hypersensitivity	3,861	3,473 (90%)	3.7×
anxiety	3,822	3,101 (81%)	2.5×
sinusitis	3,795	3,139 (83%)	6.9×
cough	3,733	2,310 (62%)	2.5×
urticaria	3,670	3,155 (86%)	4.1×
hypoaesthesia	3,648	3,082 (84%)	4.6×
muscle spasms	3,527	2,597 (74%)	3.5×
death	3,467	3,461 (100%)	0.7×
infusion related reaction	3,411	3,310 (97%)	9.8×
confusional state	3,367	3,069 (91%)	3.9×
depression	3,346	2,695 (81%)	2.7×
swelling	3,312	3,011 (91%)	6.6×
chest pain	3,254	2,863 (88%)	3.3×
hepatic enzyme increased	3,252	3,082 (95%)	9.0×
gait disturbance	3,105	2,377 (77%)	3.0×

Strongest disproportionality

Reactions over-reported for this drug vs the FAERS background (PRR), among those with ≥ 10 reports (a high PRR off a few reports is noise, not signal).

50 reactions by disproportionality:

Reaction (MedDRA PT)	Reports	Serious	PRR
nikolsky^s sign test	12	12 (100%)	494.3×
hepatitis a antibody abnormal	11	11 (100%)	275.4×
encephalitis toxic	18	18 (100%)	263.6×
appendicolith	258	258 (100%)	249.4×
sleep disorder therapy	133	133 (100%)	234.9×
antacid therapy	82	82 (100%)	217.6×
grip strength	121	121 (100%)	165.3×
c-reactive protein	480	480 (100%)	160.1×
deep vein thrombosis postoperative	1,054	1,054 (100%)	153.7×
lupus vulgaris	616	616 (100%)	147.3×
anti-cyclic citrullinated peptide antibody	317	317 (100%)	137.8×
nikolsky^s sign positive	18	18 (100%)	135.2×
bone marrow eosinophilic leukocyte count increased	10	10 (100%)	125.2×
swollen joint count	114	114 (100%)	120.8×
presbyacusis	87	87 (100%)	118.1×
rheumatic fever	1,853	1,853 (100%)	113.8×
swollen joint count increased	1,328	1,328 (100%)	112.5×
analgesic therapy	131	131 (100%)	110.5×
facet joint syndrome	1,325	1,324 (100%)	108.7×
drug therapy	117	117 (100%)	92.0×
hypocholesterolaemia	103	103 (100%)	90.9×
ejection fraction	204	204 (100%)	85.7×
x-ray abnormal	639	639 (100%)	85.6×
subcutaneous drug absorption impaired	189	189 (100%)	82.7×
hyperoxaluria	18	18 (100%)	80.7×
sensitisation	255	255 (100%)	80.6×
oxalosis	15	15 (100%)	79.7×
adjustment disorder with depressed mood	631	627 (99%)	71.9×
dark circles under eyes	16	8 (50%)	69.1×
hepatic enzyme	39	37 (95%)	68.5×
anticoagulant therapy	82	82 (100%)	68.5×
peripheral venous disease	1,167	1,165 (100%)	68.1×
sleep disorder due to general medical condition, hypersomnia type	28	28 (100%)	67.2×
duodenal ulcer perforation	2,145	2,145 (100%)	66.5×
lupus vasculitis	26	26 (100%)	62.2×
dislocation of vertebra	611	611 (100%)	61.4×
retinitis	451	450 (100%)	60.8×
congenital hiatus hernia	49	49 (100%)	59.2×
bacteroides infection	48	48 (100%)	57.6×
rheumatoid factor positive	1,485	1,484 (100%)	57.4×
anti-cyclic citrullinated peptide antibody positive	1,798	1,798 (100%)	56.3×
vaginal flatulence	67	67 (100%)	54.3×
sulphaemoglobinaemia	10	10 (100%)	54.2×
temperature regulation disorder	533	530 (99%)	53.7×
intramedullary rod insertion	124	124 (100%)	53.7×
tender joint count	19	19 (100%)	52.7×
nosocomial infection	14	14 (100%)	52.5×
malignant melanoma stage 0	41	41 (100%)	52.2×
cestode infection	13	13 (100%)	51.4×
victim of child abuse	52	52 (100%)	49.9×

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