GUAIFENESIN: 8,042 Adverse Event Reports & Safety Profile
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Drug Class: Decreased Respiratory Secretion Viscosity [PE] · Route: ORAL · Manufacturer: Ohm Laboratories, Inc. · FDA Application: 021282 · HUMAN OTC DRUG · FDA Label: Available
First Report: 1940 · Latest Report: 20250815
What Are the Most Common GUAIFENESIN Side Effects?
All GUAIFENESIN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug ineffective | 1,583 | 19.7% | 8 | 71 |
| Incorrect drug administration duration | 490 | 6.1% | 0 | 5 |
| No adverse event | 462 | 5.7% | 0 | 1 |
| Product use in unapproved indication | 451 | 5.6% | 5 | 6 |
| Dizziness | 423 | 5.3% | 1 | 26 |
| Accidental overdose | 396 | 4.9% | 3 | 2 |
| Diarrhoea | 359 | 4.5% | 2 | 9 |
| Nausea | 344 | 4.3% | 3 | 56 |
| Headache | 308 | 3.8% | 4 | 46 |
| Product use issue | 290 | 3.6% | 4 | 5 |
| Incorrect product administration duration | 282 | 3.5% | 0 | 1 |
| Insomnia | 271 | 3.4% | 1 | 14 |
| Overdose | 271 | 3.4% | 9 | 23 |
| Wrong technique in product usage process | 263 | 3.3% | 1 | 0 |
| Drug effective for unapproved indication | 246 | 3.1% | 0 | 0 |
| Somnolence | 237 | 3.0% | 3 | 40 |
| Dyspnoea | 225 | 2.8% | 1 | 36 |
| Off label use | 213 | 2.7% | 5 | 52 |
| Vomiting | 209 | 2.6% | 5 | 25 |
| Cough | 205 | 2.6% | 1 | 19 |
Who Reports GUAIFENESIN Side Effects? Age & Gender Data
Gender: 64.3% female, 35.7% male. Average age: 63.4 years. Most reports from: US. View detailed demographics →
Is GUAIFENESIN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 1 | 0 | 0 |
| 2001 | 1 | 1 | 0 |
| 2002 | 1 | 0 | 0 |
| 2003 | 3 | 0 | 0 |
| 2004 | 1 | 0 | 0 |
| 2005 | 4 | 0 | 1 |
| 2007 | 1 | 0 | 0 |
| 2008 | 1 | 0 | 0 |
| 2009 | 6 | 1 | 1 |
| 2010 | 7 | 2 | 0 |
| 2011 | 10 | 2 | 0 |
| 2012 | 7 | 1 | 0 |
| 2013 | 30 | 4 | 3 |
| 2014 | 210 | 8 | 17 |
| 2015 | 667 | 6 | 20 |
| 2016 | 703 | 2 | 20 |
| 2017 | 406 | 6 | 13 |
| 2018 | 336 | 2 | 24 |
| 2019 | 268 | 3 | 9 |
| 2020 | 208 | 9 | 11 |
| 2021 | 150 | 3 | 16 |
| 2022 | 235 | 3 | 15 |
| 2023 | 178 | 0 | 8 |
| 2024 | 182 | 3 | 6 |
| 2025 | 93 | 0 | 4 |
What Is GUAIFENESIN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 4,414 |
| Cough | 747 |
| Respiratory tract congestion | 588 |
| Productive cough | 522 |
| Nasopharyngitis | 274 |
| Chronic obstructive pulmonary disease | 168 |
| Nasal congestion | 117 |
| Secretion discharge | 113 |
| Sinusitis | 86 |
| Pulmonary congestion | 82 |
GUAIFENESIN vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Decreased Respiratory Secretion Viscosity [PE]
Official FDA Label for GUAIFENESIN
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Directions Do not crush, chew, or break tablet. Take with a full glass of water. This product can be administered without regard for timing of meals. Adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours. Childrens under 12 years of age: do not use.
Dosage & Administration
Directions Follow dosage below or use as directed by a physician. do not take more than 6 doses in any 24-hour period. Age (yr) Dose (ml) adults and children 12 years and over 10 to 20 ml (2 to 4 teaspoonfuls) every 4 hours children 6 years to under 12 years 5 to 10 ml (1 to 2 teaspoonfuls) every 4 hours children 2 years to under 6 years 2.5 to 5 ml (1 /2 to 1 teaspoonful) every 4 hours children under 2 years consult a physician Other Information Each 5 ml contains: sodium 4 mg.
Each
10 ml contains: sodium 8 mg.
Each
15 ml contains: sodium 12 mg. Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Protect from light. DO NOT USE IF SEAL IS BROKEN.
Guaifenesin Oral
Solution is a red, raspberry flavored solution and is available in the following dosage forms: 5 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-852-17 10 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-863-56 15 ml unit-dose cups: 100 cups (10 x 10) NDC 60687-874-16
FDA Boxed Warning
Caution: do not use if imprinted seal under cap is broken or missing.
Warnings
Warnings Do not exceed recommended dosage. Do not use this product if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. Do not take this product, unless directed by a doctor, if you have heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland Do not take this product for persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. Stop use and ask a doctor if nervousness, dizziness, or sleeplessness occur cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition. new symptoms occur If pregnant or breastfeeding , ask a health professional before use. Keep out of reach of children. In case of accidental overdose, seek professional help or contact a Poison Control Center immediately.
Active Ingredient
Active ingredient(s) Guaifenesin USP, 600 mg................................................................................Expectorant Pseudoephedrine HCl USP, 60 mg......................................................Nasal Decongestant Guaifenesin USP, 1200 mg................................................................................Expectorant Pseudoephedrine HCl USP, 120 mg......................................................Nasal Decongestant
Inactive Ingredients
Inactive Ingredients: Blue Cohosh root extract, Citric Acid, Echinacea root extract, Eucalyptus Oil, Ginkgo Biloba leaf extract, Glycerin, Golden Seal Root extract, Honey Flavor, Horehound, Licorice Root extract, Menthol, Methylparaben, Mullein Leaf extract, Myrrh gum extract, Potassium Citrate, Potassium Sorbate, Propylene Glycol, Propylparaben, Slippery Elm Bark extract, Sodium Chloride, Sucralose, Water, Wild Cherry Bark extract and Zinc Sulfate.