Vosol hc, Plenadren(hydrocortisone)
Achromycin, Alkindi, Alphaderm, Calmurid, Casporyn, Cipro, Coly-mycin, Cor-oticin, Cortef, Cortenema, Cortifoam, Cortisporin, Efmody, Hydrocortone, Neo-cort-dome, Neo-cortef, Ophthocort, Otobiotic, Plenadren, Pramosone, Pyocidin, Solu-cortef, Terra-cortril, Vosol, Westcort, Xerese (hydrocortisone) is a small molecule pharmaceutical. Hydrocortisone was first approved as Vosol hc on 1982-01-01. It is used to treat adrenal insufficiency, congenital adrenal hyperplasia, contact dermatitis, facial dermatoses, and foot dermatoses amongst others in the USA. It has been approved in Europe to treat adrenal insufficiency and congenital adrenal hyperplasia. The pharmaceutical is active against glucocorticoid receptor. In addition, it is known to target mineralocorticoid receptor.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Alkindi, Cortef, Cortenema, Cortifoam, Solu-cortef (generic drugs available since 1982-01-01, discontinued: , A-hydrocort, Acticort, Aeroseb-hc, Ala-cort, Balneol-hc, Beta-hc, Carmol, Cetacort, Cort-dome, Cortef, Cortril, Dermacort, Dricort, Eldecort, Epicort, Flexicort, Glycort, H-cort, Hemsol-hc, Hi-cor, Hydro-rx, Hydrocortone, Hytone, Micort-hc, Nogenic, Nutracort, Orabase hca, Penecort, Proctocort, Stie-cort, Synacort, Texacort, U-cort, Westcort)
CombinationsCasporyn, Cipro, Coly-mycin, Vosol, Xerese (generic drugs available since 1982-01-01, discontinued: Acetasol, Achromycin, Alphaderm, Calmurid, Cor-oticin, Cortisporin, Neo-cort-dome, Neo-cortef, Ophthocort, Orlex, Oticair, Otobione, Otobiotic, Otocort, Pediotic, Pramosone, Pyocidin, Terra-cortril)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Acetic acid
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glacial
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Hydrocortisone
Acetic acid
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glacial
+
Hydrocortisone
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Neomycin sulfate
Acyclovir
+
Hydrocortisone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| XERESE | Bausch Health Companies | N-022436 RX | 2009-07-31 | 1 products, RLD, RS |
Bacitracin zinc
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Hydrocortisone
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Neomycin sulfate
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Polymyxin b sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CORTISPORIN | Casper Pharma | N-050416 DISCN | 1982-01-01 | 1 products, RLD |
| CORTISPORIN | Monarch Pharmaceuticals | N-050168 DISCN | 1984-05-04 | 1 products, RLD |
Hide discontinued
Chloramphenicol
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Hydrocortisone acetate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CHLOROMYCETIN HYDROCORTISONE | Parkedale Pharmaceuticals | N-050202 DISCN | 1982-01-01 | 1 products |
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Chloramphenicol
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Hydrocortisone acetate
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Polymyxin b sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OPHTHOCORT | Parkedale Pharmaceuticals | N-050201 DISCN | 1982-01-01 | 1 products |
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Ciprofloxacin hydrochloride
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Hydrocortisone
Colistin sulfate
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Hydrocortisone acetate
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Neomycin sulfate
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Thonzonium bromide
Hydrocortisone
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CORTENEMA | ANI PHARMS | N-016199 RX | 1982-01-01 | 1 products, RLD, RS |
| ALKINDI SPRINKLE | Eton Pharmaceuticals | N-213876 RX | 2020-09-29 | 4 products, RLD, RS |
| CORTEF | Pharmacia & Upjohn | N-008697 RX | 1982-01-01 | 3 products, RLD |
Show 8 discontinued
Hydrocortisone
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Neomycin sulfate
Hydrocortisone
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Neomycin sulfate
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Polymyxin b sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CASPORYN HC | Casper Pharma | N-060613 RX | 1982-01-01 | 1 products, RLD, RS |
Show 2 discontinued
Hydrocortisone
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Tetracycline hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ACHROMYCIN | Lederle Laboratories | N-050272 DISCN | 1982-01-01 | 1 products |
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Hydrocortisone acetate
Hydrocortisone acetate
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Neomycin sulfate
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Polymyxin b sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CORTISPORIN | Monarch Pharmaceuticals | N-050218 DISCN | 1985-08-09 | 1 products, RLD |
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Hydrocortisone cypionate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| CORTEF | Pharmacia & Upjohn | N-009900 DISCN | 1982-01-01 | 1 products |
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Hydrocortisone sodium phosphate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HYDROCORTONE | Merck KGaA | N-012052 DISCN | 1982-01-01 | 1 products, RLD |
Hide discontinued
Hydrocortisone sodium succinate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SOLU-CORTEF | Pharmacia & Upjohn | N-009866 RX | 1982-01-01 | 4 products, RLD, RS |
Hydrocortisone valerate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| WESTCORT | Sun Pharmaceutical Industries | N-017950 DISCN | 1982-01-01 | 1 products, RLD |
| WESTCORT | Sun Pharmaceutical Industries | N-018726 DISCN | 1983-08-08 | 1 products, RLD |
Hide discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| OTC monograph not final | 2012-08-24 | |
| (chloroprocaine hci | New Drug Application | 2024-01-29 |
| 0.25% bupivacaine hcl bupivacaine hydrochloride | ANDA | 2024-01-28 |
| 1 hydrocortisone | OTC monograph not final | 2016-06-15 |
| 1% hydrocortisone | OTC monograph not final | 2022-12-17 |
| 1% lidocaine hci | ANDA | 2024-01-30 |
| 141016 hydrocortisone 0.5% / hydroquinone 4% / tretinoin 0.025% | unapproved drug other | 2020-07-02 |
| 141017 hydrocortisone 0.5% / hydroquinone 6% / tretinoin 0.025% | unapproved drug other | 2020-07-02 |
| 141060 hydrocortisone 0.5% / hydroquinone 4% / tretinoin 0.025% | unapproved drug other | 2020-07-02 |
| 141061 hydrocortisone 0.5% / hydroquinone 8% / tretinoin 0.025% | unapproved drug other | 2020-07-02 |
Show 491 more
Indications
FDA
EMA
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Agency Specific
FDA
EMA
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A01: Stomatological preparations
— A01A: Stomatological preparations
— A01AC: Corticosteroids for local oral treatment
— A01AC03: Hydrocortisone
— A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
— A07E: Intestinal antiinflammatory agents
— A07EA: Corticosteroids acting locally
— A07EA02: Hydrocortisone
C: Cardiovascular system drugs
— C05: Vasoprotectives
— C05A: Agents for treatment of hemorrhoids and anal fissures for topical use
— C05AA: Corticosteroids, topical for treatment of hemorrhoids and anal fissures
— C05AA01: Hydrocortisone
D: Dermatologicals
— D07: Corticosteroids, dermatological preparations
— D07A: Corticosteroid dermatological preparations, plain
— D07AA: Corticosteroids, weak (group i)
— D07AA02: Hydrocortisone
— D07AB: Corticosteroids, moderately potent (group ii)
— D07AB02: Hydrocortisone butyrate
— D07AB11: Hydrocortisone buteprate
— D07AC: Corticosteroids, potent (group iii)
— D07AC16: Hydrocortisone aceponate
— D07B: Corticosteroids, combinations with antiseptics
— D07BA: Corticosteroids, weak, combinations with antiseptics
— D07BA04: Hydrocortisone and antiseptics
— D07BB: Corticosteroids, moderately potent, combinations with antiseptics
— D07BB04: Hydrocortisone butyrate and antiseptics
— D07C: Corticosteroids, combinations with antibiotics
— D07CA: Corticosteroids, weak, combinations with antibiotics
— D07CA01: Hydrocortisone and antibiotics
— D07X: Corticosteroids, other combinations
— D07XA: Corticosteroids, weak, other combinations
— D07XA01: Hydrocortisone
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H02: Corticosteroids for systemic use
— H02A: Corticosteroids for systemic use, plain
— H02AB: Glucocorticoids, systemic
— H02AB09: Hydrocortisone
R: Respiratory system drugs
— R01: Nasal preparations
— R01A: Decongestants and other nasal preparations for topical use
— R01AD: Corticosteroid nasal preparations for topical use
— R01AD60: Hydrocortisone, combinations
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01B: Antiinflammatory agents, ophthalmologic
— S01BA: Corticosteroid ophthalmologic antiinflammatory agents, plain
— S01BA02: Hydrocortisone
— S01BB: Corticosteroids and mydriatics in combination
— S01BB01: Hydrocortisone and mydriatics
— S01C: Antiinflammatory agents and antiinfectives in combination
— S01CA: Corticosteroids and antiinfectives in combination, opthalmologic
— S01CA03: Hydrocortisone and antiinfectives
— S01CB: Corticosteroids/antiinfectives/mydriatics in combination
— S01CB03: Hydrocortisone
— S02: Otologicals
— S02B: Corticosteroid otologicals
— S02BA: Corticosteroids
— S02BA01: Hydrocortisone
— S02C: Corticosteroids and antiinfectives in combination, otologic
— S02CA: Corticosteroids and antiinfectives in combination
— S02CA03: Hydrocortisone and antiinfectives
— S03: Ophthalmological and otological preparations
— S03C: Corticosteroids and antiinfectives in combination, opthalmologic and otologic
— S03CA: Corticosteroids and antiinfectives in combination
— S03CA04: Hydrocortisone and antiinfectives
Clinical
Clinical Trials
4138 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 35 | 57 | 26 | 11 | 5 | 115 |
| Prostatic neoplasms | D011471 | — | C61 | 14 | 61 | 24 | 6 | 11 | 106 |
| Lymphoma | D008223 | — | C85.9 | 13 | 45 | 26 | 1 | 11 | 91 |
| Healthy volunteers/patients | — | — | — | 35 | 5 | 4 | 10 | 19 | 72 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 4 | 20 | 15 | 19 | 7 | 64 |
| Asthma | D001249 | EFO_0000270 | J45 | 9 | 8 | 11 | 19 | 16 | 63 |
| Adrenal insufficiency | D000309 | — | — | 7 | 3 | 7 | 14 | 31 | 61 |
| Covid-19 | D000086382 | — | U07.1 | 2 | 7 | 19 | 5 | 27 | 56 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 14 | 36 | 8 | 2 | — | 51 |
| Neoplasms | D009369 | — | C80 | 21 | 16 | 6 | 2 | 10 | 48 |
Show 346 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 15 | 57 | 19 | — | 10 | 88 |
| Myelodysplastic syndromes | D009190 | — | D46 | 15 | 42 | 5 | — | 5 | 60 |
| Graft vs host disease | D006086 | — | D89.81 | 11 | 28 | 11 | — | 5 | 49 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 8 | 25 | 3 | — | 4 | 35 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 17 | 19 | 4 | — | — | 32 |
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | — | 7 | 7 | — | 17 | 31 |
| Uterine cervical neoplasms | D002583 | HP_0030159 | — | 2 | — | 2 | — | 22 | 26 |
| Hodgkin disease | D006689 | — | C81 | 5 | 16 | 6 | — | 1 | 24 |
| Multiple myeloma | D009101 | — | C90.0 | 6 | 10 | 7 | — | 1 | 23 |
| Cushing syndrome | D003480 | EFO_0003099 | E24 | — | 2 | 2 | — | 17 | 21 |
Show 208 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 1 | 15 | — | — | 1 | 16 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 4 | 8 | — | — | 3 | 14 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 1 | 8 | — | — | 2 | 11 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 2 | — | — | 7 | 10 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | 5 | — | — | 3 | 8 |
| T-cell lymphoma peripheral | D016411 | — | — | 4 | 6 | — | — | — | 8 |
| Fanconi anemia | D005199 | Orphanet_84 | D61.09 | 3 | 6 | — | — | 1 | 8 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 1 | 6 | — | — | — | 7 |
| Head and neck neoplasms | D006258 | — | — | 2 | 4 | — | — | 3 | 7 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 2 | 5 | — | — | 2 | 7 |
Show 194 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 2 | — | — | — | 8 | 10 |
| Blood pressure | D001794 | EFO_0004325 | — | 2 | — | — | — | 5 | 7 |
| Overweight | D050177 | — | E66.3 | 1 | — | — | — | 5 | 6 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | 1 | — | — | — | 4 | 5 |
| Alcohol drinking | D000428 | EFO_0004329 | — | 1 | — | — | — | 4 | 5 |
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | 1 | 4 |
| Regeneration | D012038 | — | — | 1 | — | — | — | 3 | 4 |
| Pseudomonas infections | D011552 | EFO_0001076 | A41.52 | 2 | — | — | — | 1 | 3 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | 2 | — | — | — | 1 | 3 |
| Laron syndrome | D046150 | Orphanet_633 | E34.321 | 1 | — | — | — | 2 | 3 |
Show 78 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 5 | 5 |
| Feeding behavior | D005247 | — | — | — | — | — | — | 5 | 5 |
| Psychological distress | D000079225 | — | — | — | — | — | — | 5 | 5 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | — | — | — | 4 | 4 |
| Dental anxiety | D016854 | — | — | — | — | — | — | 4 | 4 |
| Pulmonary arterial hypertension | D000081029 | — | — | — | — | — | — | 3 | 3 |
| Intervertebral disc displacement | D007405 | EFO_1001800 | — | — | — | — | — | 3 | 3 |
| Affect | D000339 | — | — | — | — | — | — | 3 | 3 |
| Professional burnout | D002055 | — | — | — | — | — | — | 3 | 3 |
| Pathologic dilatation | D004108 | — | — | — | — | — | — | 3 | 3 |
Show 331 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Hydrocortisone |
| INN | hydrocortisone |
| Description | Cortisol is a 17alpha-hydroxy-C21-steroid that is pregn-4-ene substituted by oxo groups at positions 3 and 20 and hydroxy groups at positions 11, 17 and 21. Cortisol is a corticosteroid hormone or glucocorticoid produced by zona fasciculata of the adrenal cortex, which is a part of the adrenal gland. It is usually referred to as the "stress hormone" as it is involved in response to stress and anxiety, controlled by corticotropin-releasing hormone (CRH). It increases blood pressure and blood sugar, and reduces immune responses. It has a role as an anti-inflammatory drug, an anti-allergic agent, an anti-asthmatic drug, a human metabolite, a mouse metabolite and a drug allergen. It is a 21-hydroxy steroid, an 11beta-hydroxy steroid, a 20-oxo steroid, a 3-oxo-Delta(4) steroid, a primary alpha-hydroxy ketone, a tertiary alpha-hydroxy ketone, a 17alpha-hydroxy-C21-steroid and a glucocorticoid. It derives from a hydride of a pregnane. |
| Classification | Small molecule |
| Drug class | cortisone derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C[C@]12C[C@H](O)[C@H]3[C@@H](CCC4=CC(=O)CC[C@@]43C)[C@@H]1CC[C@]2(O)C(=O)CO |
Identifiers
| PDB | — |
| CAS-ID | 50-23-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL389621 |
| ChEBI ID | 17650 |
| PubChem CID | 5754 |
| DrugBank | DB00741 |
| UNII ID | WI4X0X7BPJ (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
NR3C2
NR3C2
Organism
Homo sapiens
Gene name
NR3C2
Gene synonyms
MCR, MLR
NCBI Gene ID
Protein name
mineralocorticoid receptor
Protein synonyms
aldosterone receptor, mineralocorticoid receptor 1, mineralocorticoid receptor 2, mineralocorticoid receptor delta, Nuclear receptor subfamily 3 group C member 2
Uniprot ID
Mouse ortholog
Nr3c2 (110784)
mineralocorticoid receptor (Q8VII8)
Variants
No data
Financial
Revenue by drug
$
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Estimated US medical usage
Hydrocortisone
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Hydrocortisone
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Hydrocortisone
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Clioquinol
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Hydrocortisone
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Neomycin
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Polymyxin b
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Oxytetracycline
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Trends
PubMed Central
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Additional graphs summarizing 192,156 documents
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Safety
Black-box Warning
Black-box warning for: 0.25% bupivacaine hcl bupivacaine hydrochloride, Ciprofloxacin, Ciprofloxacin and dextrose, Ciprofloxacin ciprofloxacin, Ciprofloxacin hcl, Ciprofloxacin in dextrose, Promethazine hci, Promethazine hcl, phenylephrine hcl, codeine phosphate, Proquin, Proquin xr, Quinapril hcl and hydrochlorothiazide, Sensorcaine(r) (bupivacaine hci and epinephrine)
Adverse Events
Top Adverse Reactions
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67,980 adverse events reported
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