Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Guaifenesin
Drug ID BADD_D01043
Description Guaifenesin possesses a storied history, having been originally formally approved by the US FDA in 1952 and continues to be one of very few - if not perhaps the only drug that is readily available and used as an expectorant [F4525]. Since that time the agent has been a combination component of various prescription and non-prescription over-the-counter cough and cold products and is currently a widely available over-the-counter generic medication [F4525]. Although it is principally believed that guaifenesin elicits an action to facilitate productive cough to manage chest congestion [A177661, L6100, F4516, F4522, F4525], it is not known whether the agent can reliably mitigate coughing. Regardless, on March 1, 2007, the FDA received a petition asking the FDA to notify the public that some antitussives, expectorants, decongestants, antihistamines, and cough/cold combinations are not known to be safe and effective in children under the age of 6 years [F4525]. After the negotiation between FDA and major manufacturers, a voluntary transition of labels for not using guaifenesin in children under the age of 4 years was endorsed by FDA in 2008 [F4525]. Furthermore, there has also been contemporary research to suggest that guaifenesin possesses and is capable of demonstrating anticonvulsant and muscle relaxant effects to some degree possibly by acting as an NMDA receptor antagonist [A177652].
Indications and Usage Used to assist the expectoration of phlegm from the airways in acute respiratory tract infections.
Marketing Status OTC
ATC Code R05CA03
DrugBank ID DB00874
KEGG ID D00337
MeSH ID D006140
PubChem ID 3516
TTD Drug ID Not Available
NDC Product Code 50804-858; 70518-2782; 36800-515; 58602-810; 65162-036; 63629-1156; 0591-3638; 69230-315; 71679-148; 63824-008; 0363-0310; 58602-865; 63629-8348; 50804-857; 0363-0033; 37012-727; 70518-3283; 63868-148; 65162-037; 59726-107; 53041-233; 70677-0050; 37012-728; 0363-0532; 58343-0130; 68998-845; 69842-995; 62207-839; 58602-811; 53943-507; 50090-1340; 10135-681; 68210-0116; 53499-0232; 69168-330; 0121-1744; 69822-020; 53041-234; 62207-570; 58343-0122; 36800-420; 71610-434; 69618-061; 59800-1365; 64024-222; 49580-0389; 24385-602; 63981-532; 68210-4158; 59651-106; 63739-067; 30142-107; 69842-732; 41250-672; 49035-325; 41250-654; 50090-4856; 55910-732; 17856-0693; 21130-206; 59651-107; 62207-950; 81179-007; 0536-1163; 37808-935; 70518-2004; 11822-0732; 53041-191; 10956-059; 72288-298; 41250-684; 57896-614; 50090-2301; 55319-902; 15187-006; 0536-1314; 71335-1035; 70518-1782; 41520-732; 0121-2232; 33992-0389; 38779-0696; 21130-101; 70000-0251; 51660-070; 59800-0232; 62207-840; 50090-2675; 0536-1182; 58602-864; 68071-2663; 10135-682; 49348-135; 69168-370; 17856-0008; 0363-0325; 76281-507; 63868-770; 79395-001; 0904-6718; 61787-514; 62011-0377; 10956-002; 73581-402; 58657-509; 11822-7329; 11822-7836; 41520-731; 63868-859; 68391-000; 59779-948; 70677-0049; 50804-107; 69848-017; 55319-107; 0363-0288; 11673-731; 63629-7886; 63824-023; 55910-739; 69842-806; 81522-006; 70518-2824; 70000-0299; 66326-205; 41250-713; 41250-732; 51927-1147; 71141-135; 10956-845; 30142-471; 69256-310; 11822-3252; 53041-190; 51467-009; 57896-714; 58552-146; 68210-6110; 62011-0089; 46122-057; 41226-272; 76457-004; 0904-6986; 41163-113; 0363-0832; 55681-301; 50090-0818; 72559-001; 63629-7115; 76281-309; 58593-255; 41415-996; 80267-002; 69230-314; 46122-416; 70518-3045; 37808-762; 58602-853; 58552-145; 11822-2252; 67296-0569; 41520-288; 68210-4173; 54838-130; 76281-318; 0113-0061; 49452-3420; 55315-732; 0121-1488; 50090-4189; 49348-729; 55154-5780; 67091-375; 0363-0931; 36800-137; 63941-731; 41415-997; 0904-5154; 72559-013; 63187-341; 42213-160; 36800-932; 37808-288; 58593-829; 62207-569; 41520-534; 69256-732; 68084-572; 69848-018; 70000-0452; 68016-170; 63824-537; 63868-871; 41163-701; 55154-4680; 55301-532; 0121-0744; 68196-996; 58593-265; 57896-693; 63868-998; 60203-1001; 73581-401; 70000-0479; 62207-932; 63824-941; 55154-9450; 16103-379; 71610-499; 62011-0382; 70000-0055; 0363-7504; 53943-511; 63868-872; 67296-1804; 66652-2101; 0113-3650; 11673-732; 58343-0126; 51552-0140; 11822-0342; 63187-954; 65072-0501; 36800-226; 41250-507; 54257-776; 11673-421; 54838-138; 51316-070; 41250-892; 54838-117; 62485-027; 70677-0055; 0113-2023; 63868-149; 63940-532; 68210-4102; 60592-305; 41163-731; 62991-1075; 70518-0228; 72559-017; 42333-120; 46122-683; 62011-0060; 67544-149; 0363-0028; 72288-650; 46122-299; 50383-063; 62011-0378; 68210-1160; 46122-583; 68163-743; 10956-180; 68788-9098; 0536-1311; 21130-399; 55289-087; 68210-0611; 0904-6815; 0904-6763; 50090-2380; 59779-650; 51660-072; 56062-310; 49483-272; 68210-4130; 69842-335; 54859-507; 66326-215; 69517-148; 0113-2061; 0113-0325; 63548-0107; 67091-370; 57896-794
Synonyms Guaifenesin | Guaiphenezine | Guaiphenesin | Glycerol Guaiacolate | Guaiacolate, Glycerol | Guaiacol Glyceryl Ether | Ether, Guaiacol Glyceryl | Glyceryl Ether, Guaiacol | Guiatuss | Scott-Tussin | Scott Tussin | ScottTussin | Hytuss | My-301 | My 301 | My301 | Breonesin | Humibid
Chemical Information
Molecular Formula C10H14O4
CAS Registry Number 93-14-1
SMILES COC1=CC=CC=C1OCC(CO)O
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Dermatitis23.03.04.002--Not Available
Discomfort08.01.08.003--Not Available
Dizziness24.06.02.007; 17.02.05.003; 02.01.02.004--
Headache17.14.01.001--
Nausea07.01.07.001--
Nephrolithiasis20.04.01.002--
Rash23.03.13.001--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vomiting07.01.07.003--
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