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 Guaifenesin is an expectorant that is indicated for providing temporary symptomatic relief from congested chests and coughs which may be due to a cold, bronchitis, and/or other breathing illnesses [FDA Label, F4510, L6079].
Marketing Status approved; investigational; vet_approved
ATC Code R05CA03
DrugBank ID DB00874
KEGG ID D00337
MeSH ID D006140
PubChem ID 3516
TTD Drug ID Not Available
NDC Product Code 79903-124; 0904-6718; 10135-682; 58343-0122; 10956-059; 21130-101; 24689-122; 24689-144; 0113-0061; 30142-107; 30142-471; 0113-2023; 41250-654; 41520-534; 49580-0389; 50090-1340; 51660-070; 53942-204; 55301-532; 55319-107; 55910-626; 55910-904; 58552-146; 0363-0033; 62011-0060; 62011-0377; 62207-570; 0363-0832; 0363-7504; 63824-941; 63868-039; 63868-859; 63981-532; 67544-149; 69230-314; 0536-1314; 70677-1054; 71309-461; 76281-309; 76281-507; 80267-010; 81522-204; 83139-175; 65072-0501; 71747-003; 37808-935; 41250-672; 41250-732; 43598-110; 51316-743; 54838-117; 59726-857; 0363-0028; 62207-839; 0363-0931; 63868-871; 63941-731; 67091-370; 68071-2663; 69230-315; 70518-2782; 71141-168; 71610-499; 81179-007; 60203-1001; 62207-932; 10956-845; 11822-2123; 21130-206; 0113-3650; 36800-226; 0121-0744; 37808-762; 41250-713; 41250-892; 43598-108; 51316-071; 51660-566; 51660-567; 53041-190; 53041-234; 55910-732; 57896-614; 58593-829; 58657-509; 0363-1310; 63629-7886; 63868-872; 65162-037; 67091-403; 69168-370; 69256-732; 69842-335; 70000-0055; 70677-0055; 71679-148; 53942-203; 53943-507; 54859-507; 55154-9450; 58602-864; 59726-832; 62011-0378; 63824-537; 63868-148; 67296-1467; 67296-1804; 68001-561; 68016-170; 68094-048; 68210-4130; 68210-4158; 68998-845; 69517-148; 70518-0228; 0536-1182; 70518-3455; 70677-0049; 0536-1392; 71335-9616; 71399-0024; 71610-434; 72288-650; 73581-402; 38779-0696; 49452-3420; 58343-0126; 58343-0130; 62485-027; 66326-215; 11673-421; 21130-554; 33992-0389; 36800-137; 37012-727; 37012-728; 41226-272; 41250-507; 41250-684; 41415-997; 41520-288; 51316-008; 53499-0232; 55154-4153; 55154-5780; 55319-732; 57896-693; 58602-811; 59726-107; 59779-650; 0031-9303; 62207-569; 63629-7115; 63940-532; 68084-572; 69256-310; 69842-806; 70000-0299; 70000-0452; 0536-1163; 72288-298; 76457-004; 80267-002; 0904-6763; 43598-008; 51927-1147; 60592-305; 66652-2101; 11673-732; 41163-113; 49483-272; 53041-191; 54257-776; 57896-794; 58602-810; 58602-853; 58602-865; 0363-0532; 69848-017; 70518-2824; 70677-0050; 0536-1311; 73581-401; 82649-732; 0904-6815; 10135-681; 11822-4260; 30142-961; 30142-962; 0113-2061; 37808-288; 41163-731; 43598-009; 49348-729; 50383-063; 51467-009; 53149-2000; 55154-4680; 57896-714; 58593-255; 61787-514; 62011-0089; 62207-840; 63824-008; 63824-023; 63868-998; 65162-036; 68163-743; 68210-1160; 68210-4173; 68210-6110; 69822-200; 69848-018; 70518-1782; 70518-3445; 70677-1051; 71309-460; 72559-017; 59651-106; 11822-0342; 11822-7836; 36800-794; 0121-1744; 0121-2232; 41415-996; 55301-932; 55315-732; 56062-310; 63629-8348; 63868-149; 68016-545; 68196-996; 68210-0611; 68788-9098; 69618-061; 69842-732; 70000-0479; 71141-135; 71179-002; 79481-7430; 81522-006; 81522-203; 0904-6986; 51552-0140; 66326-205; 11822-0732; 11822-2252; 11822-3252; 24385-602; 36800-515; 41163-701; 46122-583; 49348-135; 50804-858; 53041-233; 53943-511; 55319-551; 59800-1365; 0363-0310; 62011-0382; 63187-341; 0363-7043; 63868-770; 63941-987; 64024-222; 68016-020; 69822-212; 70677-1013; 70677-1052; 72559-013; 68210-0116; 21130-179; 21130-399; 0113-0325; 36800-932; 0121-1488; 41520-732; 46122-299; 46122-683; 51660-072; 55681-301; 58552-145; 58593-265; 63187-954; 63548-0107; 63629-1156; 63739-067; 67091-404; 68391-000; 70010-199; 72559-001; 76162-123; 77333-360; 0904-5154; 58343-0144; 59651-107; 62207-950; 62991-1075; 11673-731; 11822-0731; 11822-7329; 41520-731; 50804-857; 55319-857; 55910-739
UNII 495W7451VQ
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Insomnia19.02.01.002; 17.15.03.0020.000616%
Lip swelling23.04.01.007; 10.01.05.005; 07.05.04.0050.000345%Not Available
Malaise08.01.01.0030.000364%
Muscle spasms15.05.03.0040.000205%
Nasal congestion22.04.04.0010.000317%
Nausea07.01.07.0010.001251%
Nephrolithiasis20.04.01.002--
Nervousness19.06.02.0030.000205%Not Available
Palpitations02.11.04.0120.000728%
Paraesthesia23.03.03.094; 17.02.06.0050.000205%
Pruritus23.03.12.0010.000299%
Rash23.03.13.0010.000523%Not Available
Retching07.01.07.002--Not Available
Rhinorrhoea22.12.03.0210.000476%
Serotonin syndrome15.05.04.016; 12.03.01.041; 17.05.02.0040.000093%Not Available
Somnolence19.02.05.003; 17.02.04.0060.000476%
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.000093%Not Available
Therapeutic response unexpected08.06.01.0010.000476%Not Available
Throat irritation22.12.03.029; 07.05.05.037--Not Available
Tremor17.01.06.0020.000093%
Urticaria23.04.02.001; 10.01.06.0010.000205%
Vomiting07.01.07.0030.000728%
Respiratory tract congestion22.02.07.003--Not Available
Perinephric collection20.02.03.014; 12.01.05.0030.000093%Not Available
Disease recurrence08.01.03.0500.000317%Not Available
Oropharyngeal pain22.12.03.016; 07.05.05.0040.000476%
Acute kidney injury20.01.03.0160.000093%
Concomitant disease aggravated08.01.03.063--Not Available
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