What the label lists and what reports show

Carbinoxamine side effects

Carbinoxamine's FDA label lists its adverse reactions in its own words. FAERS holds 190 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 drug toxicity (14 reports).

Generic listed

Check it at the source: the carbinoxamine FDA label on DailyMed (effective March 6, 2024, Genus Lifesciences Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
The most frequent adverse reactions are underlined: Body as a Whole: Urticaria, drug rash, anaphylactic shock, photosensitivity, excessive perspiration, chills, dryness of mouth, nose and throat. Cardiovascular: Hypotension, headache, palpitations, tachycardia, extrasystoles. Hematologic: Hemolytic anemia, thrombocytopenia, agranulocytosis. Central Nervous System: Sedation, sleepiness, dizziness, disturbed coordination, fatigue, confusion, restlessness, excitation, nervousness, tremor, irritability, insomnia, euphoria, paresthesia, blurred vision, diplopia, vertigo, tinnitus, acute labyrinthitis, hysteria, neuritis, convulsions. Gastrointestinal: Epigastric distress, anorexia, nausea, vomiting, diarrhea, constipation. Urogenital: Urinary frequency, difficult urination, urinary retention, early menses. …

Source: FDA drug label, Genus Lifesciences Inc., effective March 6, 2024 (SPL set 9d11b197-cfdc-4b9b-9935-2920ccb6e522), via openFDA; the full label on DailyMed

What do FAERS reports show?

190 reports list carbinoxamine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 29 are coded as a death and 29 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 21 reactions below, 7 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

Drug Ineffective (a use or a product term, not a reaction)16
Drug Toxicity14
Headache (named in the label)14
Sinusitis10
Pain9
Pyrexia9
Fatigue (named in the label)8
Pruritus8
Urticaria (a use or a product term, not a reaction)8
Dizziness (named in the label)7
Product Dose Omission Issue (a use or a product term, not a reaction)7
Rash (named in the label)7
Somnolence7
Unresponsive To Stimuli7
Vomiting (named in the label)7
Anxiety6
Arthralgia6
Chest Pain6
Cough6
Hypersensitivity6
Insomnia (named in the label)6
Loss Of Consciousness6
Nausea (named in the label)6
Off Label Use (a use or a product term, not a reaction)6
Asthenia5

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

What next?

Carbinoxamine: 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