What the label lists and what reports show
Orphenadrine side effects
Orphenadrine's FDA label lists its adverse reactions in its own words. FAERS holds 621 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 pain (65 reports).
- Generic listed
Check it at the source: the orphenadrine FDA label on DailyMed (effective September 10, 2025, Lupin Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAdverse reactions of orphenadrine are mainly due to the mild anticholinergic action of orphenadrine, and are usually associated with higher dosage. Dryness of the mouth is usually the first adverse effect to appear. When the daily dose is increased, possible adverse effects include: tachycardia, palpitation, urinary hesitancy or retention, blurred vision, dilatation of pupils, increased ocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, hypersensitivity reactions, pruritus, hallucinations, agitation, tremor, gastric irritation, and rarely urticaria and other dermatoses. Infrequently, an elderly patient may experience some degree of mental confusion. These adverse reactions can usually be eliminated by reduction in dosage. Very rare cases of aplastic anemia associated with the use of orphenadrine tablets have been reported. …
Source: FDA drug label, Lupin Pharmaceuticals, Inc., effective September 10, 2025 (SPL set 7b76c8a7-dd0c-481c-8299-26dfd38ce066), via openFDA; the full label on DailyMed
What do FAERS reports show?
621 reports list orphenadrine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 65 are coded as a death and 173 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 24 reactions below, 6 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.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Orphenadrine: 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