What the label lists and what reports show

Flavoxate side effects

Flavoxate's FDA label lists its adverse reactions in its own words. FAERS holds 101 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (13 reports).

Generic listed

Check it at the source: the flavoxate FDA label on DailyMed (effective December 27, 2023, Epic Pharma, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
The following adverse reactions have been observed, but there are not enough data to support an estimate of their frequency. Gastrointestinal: Nausea, vomiting, dry mouth. CNS: Vertigo, headache, mental confusion, especially in the elderly, drowsiness, nervousness. Hematologic: Leukopenia (one case which was reversible upon discontinuation of the drug). Cardiovascular: Tachycardia and palpitation. Allergic: Urticaria and other dermatoses, eosinophilia and hyperpyrexia. Ophthalmic: Increased ocular tension, blurred vision, disturbance in eye accommodation. Renal: Dysuria.

Source: FDA drug label, Epic Pharma, LLC, effective December 27, 2023 (SPL set b4260d7e-2ab3-49f6-aa57-bae19a23d82a), via openFDA; the full label on DailyMed

What do FAERS reports show?

101 reports list flavoxate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 57 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 23 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

Pyrexia13
Mucosal Inflammation10
Pruritus9
Hepatic Function Abnormal8
Toxic Epidermal Necrolysis8
Pneumonia7
Aspartate Aminotransferase Increased6
Exposed Bone In Jaw6
Oral Disorder6
Oroantral Fistula6
Osteonecrosis Of Jaw6
Alanine Aminotransferase Increased5
Blood Lactate Dehydrogenase Increased5
Decreased Appetite5
Lip Erosion5
Nausea (named in the label)5
Ocular Hyperaemia5
Skin Lesion5
Cheilitis4
Constipation4
Drug Ineffective (a use or a product term, not a reaction)4
Dysuria (a use or a product term, not a reaction)4
Erythema4
Gamma-Glutamyltransferase Increased4
Headache (named in the label)4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Flavoxate: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions