Drug
Guaifenesin And Pseudoephedrine Hydrochloride
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Accidental Overdose | 76 | 22.7 | 23.6 | signal |
| 2 | Incorrect Drug Administration Duration | 53 | 20.3 | 20.8 | signal |
| 3 | Incorrect Product Administration Duration | 25 | 13.4 | 13.6 | signal |
| 4 | Feeling Jittery | 20 | 11.4 | 11.5 | signal |
| 5 | Expired Product Administered | 29 | 9.5 | 9.7 | signal |
| 6 | Dysuria | 30 | 8.9 | 9.0 | signal |
| 7 | Seasonal Allergy | 11 | 8.5 | 8.5 | signal |
| 8 | Sinus Congestion | 10 | 8.1 | 8.1 | signal |
| 9 | Sinusitis | 72 | 7.6 | 7.9 | signal |
| 10 | Tooth Infection | 9 | 7.4 | 7.5 | signal |
| 11 | Bronchitis | 47 | 6.9 | 7.0 | signal |
| 12 | Respiratory Tract Congestion | 10 | 6.9 | 6.9 | signal |
| 13 | Nervousness | 33 | 6.8 | 7.0 | signal |
| 14 | Insomnia | 165 | 6.7 | 7.3 | signal |
| 15 | Dry Throat | 6 | 6.4 | 6.5 | signal |
| 16 | Heart Rate Increased | 55 | 6.1 | 6.2 | signal |
| 17 | Infusion Site Pain | 7 | 6.0 | 6.0 | signal |
| 18 | Psychomotor Hyperactivity | 9 | 5.9 | 5.9 | signal |
| 19 | Ear Infection | 14 | 5.7 | 5.8 | signal |
| 20 | Initial Insomnia | 5 | 5.3 | 5.4 | signal |
| 21 | Anosmia | 7 | 5.3 | 5.3 | signal |
| 22 | Restlessness | 17 | 5.1 | 5.1 | signal |
| 23 | Disease Recurrence | 22 | 5.0 | 5.1 | signal |
| 24 | Epistaxis | 33 | 4.8 | 4.9 | signal |
| 25 | Drug Effective For Unapproved Indication | 12 | 4.5 | 4.5 | signal |
| 26 | Hospice Care | 4 | 4.4 | 4.4 | signal |
| 27 | Product Use Complaint | 6 | 4.2 | 4.2 | signal |
| 28 | Tooth Extraction | 4 | 3.5 | 3.5 | signal |
| 29 | Pharyngeal Oedema | 5 | 3.5 | 3.5 | signal |
| 30 | Underdose | 23 | 3.4 | 3.5 | signal |
| 31 | Mydriasis | 4 | 3.4 | 3.4 | signal |
| 32 | Wrong Technique In Drug Usage Process | 11 | 3.3 | 3.3 | signal |
| 33 | Overdose | 64 | 3.2 | 3.3 | signal |
| 34 | Internal Haemorrhage | 3 | 2.9 | 2.9 | no signal |
| 35 | Injection Site Discolouration | 3 | 2.6 | 2.6 | no signal |
| 36 | Multiple Fractures | 4 | 2.6 | 2.6 | no signal |
| 37 | Product Taste Abnormal | 3 | 2.4 | 2.4 | no signal |
| 38 | No Adverse Event | 34 | 2.1 | 2.1 | signal |
| 39 | Plasma Cell Myeloma | 7 | 2.0 | 2.0 | no signal |
| 40 | Injection Site Pruritus | 8 | 1.3 | 1.3 | no signal |
| 41 | Injection Site Swelling | 9 | 1.3 | 1.3 | no signal |
| 42 | Drug Abuse | 7 | 0.9 | 0.9 | no signal |