Drug Safety Information for MUCINEX (Guaifenesin)

Safety-related Labeling Changes for HYCOFENIX (GUAIFENESIN; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for FLOWTUSS (GUAIFENESIN; HYDROCODONE BITARTRATE) Discontinued Drug: FDA Link

Safety-related Labeling Changes for OBREDON (GUAIFENESIN; HYDROCODONE BITARTRATE) Discontinued Drug: FDA Link

Adverse Drug Reactions for MUCINEX* (Guaifenesin)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with MUCINEX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea1128
2Nausea826
3Pneumonia714
4Pain710
5Dizziness*683
6Drug ineffective671
7Fatigue664
8Cough660
9Headache*646
10Anxiety*595
11Diarrhoea585
12Asthenia575
13Vomiting503
14Chest pain467
15Hypertension458
16Insomnia*409
17Depression409
18Pyrexia402
19Bronchitis397
20Chronic obstructive pulmonary disease393

* This side effect also appears in "Top 10 Side Effects of MUCINEX " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking MUCINEX
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Product used for unknown indication6700
2Cough*2609
3Nasopharyngitis*627
4Hypersensitivity478
5Bronchitis422
6Sinusitis379
7Respiratory tract congestion*367
8Nasal congestion344
9Asthma327
10Chronic obstructive pulmonary disease300

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for MUCINEX

Total Reports Filed with FDA: 75834


Number of FDA Adverse Event Reports by Patient Age for MUCINEX

Total Reports Filed with FDA: 75834*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Guaifenesin (Donatussin dc, Iophen dm, Crantex la, Robitussin ac, Duratuss g, Expectorant, Giltuss, Humibid, Allfen c, Aquabid dm, Duratuss hd, Mucosa, Organidin, Kwelcof, Guaivent, Brontex, Primatene, Aquatab d, Wellbid-d, Guaifenex la, Duratuss gp, Pneumotussin, Zephrex, Hycotuss, Atuss g, Fenesin, Maxiphen dm, Guaifen-c, Adult tussin, Q-tussin, Muco-fen, Vortex, Muco-fen dm, Guaimax-d, Halotussin, Bronchoril, Equate tussin, Genexpect dm, Donatussin, Quindal, Relacon-dm, Cough out, Levall g, Crantex, Difil g, Organidin nr, Tussin cf cough, Iophen nr, Leader adult tussin, Leader mucus relief, Liqufruta, Robitussin dm, Panmist dm, Pseudovent dm, Mucus relief chest, Vicodin tuss, Qtussin, Dilex, Siltussin das, Siltussin sa, Smart sense tussin, Sunmark tussin, Tussin chest, Tussin original, Guiafenesin, Benylin expectorant, Guiatex, Z-dex, Exgest la, Dynex, Mucinex, Zotex, Phentex, Deconex dmx, Touro ex, Guiadex, Tussin, Bidex-400, Careone mucus relief, Good sense mucus er, Guaap, Leader cough tabs, Leader mucus er, Leader tabtussin 400, Liquituss gg, Mucus er, Mucus relief er, Sunmark mucus er, Topcare mucus er, Ultra tuss, Robitussin-pe, Amibid dm, Drituss g, Tussin expectorant, Careone adult tussin, Careone mucus er, Equaline mucus er, Equate mucus er, Health mart mucus er, Mucus releif, Ritussin expectorant, Simpex guaifenesin, Smart sense mucus er, Norel, Gani-tuss nr, Iophen, Oratuss, Q-bid dm, Robitussin-dac, Guaifenex gp, Q-bid la, Lusonex, Medent ld, Profen forte dm, Panmist, Tuss dm, Dura-vent, Duraphen ii, Muco-fen la, Maxiphen, Poly-vent, Pseudovent, Congestac, Levall, Sinuvent, Maxifed dmx, Tussadur-hd, Zephrex la, Liquibid-d, Hytuss, Panmist jr, Mucus relief, Guaifenex g, Quintex, Profen ii dm, Tussi-bid, Tussafed-hcg, Execof, Miraphen pse, Drituss gp, Profen ii, Phenavent la, Pseudovent ped, Duratuss, Pancof xp, Robitussin-ac, Aquatab dm, Maxifed-g, Tussin cf, Deconex, Humibid l.a., Phenavent, Mytussin ac, Halotussin ac, Ami-tex, Mucinex for kids, Q-bid, Guaifed, Giltuss tr, Banex, Dyphylline gg, Duradex, Mucaplex, Organ-i nr, Air power, Guiatuss ac, Maxifed, Allfen, Endal, Iophen-c nr, Codiclear dh, Prolex d, Guiatuss, Robafen dm, Touro la, Robitussin, Nasabid sr, Siltussin, Sudal sr, Mytussin, Phenylfenesin la, Profen forte, Drituss dm, Tusso-c, Respa dm, Tussex, Xpect, Tussin pe, Guaifenex dm, Dilor-g, Novahistine dmx, Robitussin-cf, Entex pse, Guaifenesin la, Su-tuss hd, Touro la-ld, Simuc, Duraphen forte, Guiatex la, Panmist la, Entex liquid, Q-tussin dm, Ami-tex la, Entex er, Liquibid, Gentex hc, Guaifed pd, Dilex-g, Mytussin dac, Sitrex, Medent dm, Deconsal ii, Prolex pd, Broncholate, Refenesen, Ru-tuss, Extendryl g, Humibid dm, Amibid la, Codafen, Bidex, Guaifenex, Medent, Guiatussin dac, Duramax, Vental, Nalex, Duraphen dm, Guaifenesin)

Charts are based on 75834 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

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Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.