What the label lists and what reports show
Aspirin and caffeine and orphenadrine side effects
Aspirin and caffeine and orphenadrine's FDA label lists its adverse reactions in its own words. FAERS holds 128 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 nausea (17 reports).
- Generic listed
Check it at the source: the aspirin and caffeine and orphenadrine FDA label on DailyMed (effective January 8, 2026, Galt Pharmaceuticals, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsSide effects of Norgesic TM Tablets are those seen with aspirin and caffeine or those usually associated with mild anti-cholinergic agents. These may include tachycardia, palpitation, urinary hesitancy or retention, dry mouth, blurred vision, dilation of the pupil, increased intraocular tension, weakness, nausea, vomiting, headache, dizziness, constipation, drowsiness, and rarely, urticaria and other dermatosis. Infrequently, an elderly patient may experience some degree of confusion. Mild central excitation and occasional hallucinations may be observed. These mild side effects can usually be eliminated by reduction in dosage. One case of aplastic anemia associated with the use of orphenadrine citrate, aspirin and caffeine has been reported. No causal relationship has been established. Rare G.I. …
Source: FDA drug label, Galt Pharmaceuticals, LLC, effective January 8, 2026 (SPL set be2761bc-e537-4039-846a-2ffa3d8b2afc), via openFDA; the full label on DailyMed
What do FAERS reports show?
128 reports list aspirin and caffeine and orphenadrine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 39 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 22 reactions below, 5 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Aspirin and caffeine and 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