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What the label lists and what reports show

Ephedrine side effects

Ephedrine's FDA label: “Most common adverse reactions during treatment: nausea, vomiting, and tachycardia.” FAERS holds 212 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 abuse (15 reports).

  • Generic listed

Check it at the source: the ephedrine FDA label on DailyMed (effective September 16, 2024, Nexus Pharmaceuticals, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common adverse reactions during treatment: nausea, vomiting, and tachycardia.

From the label: adverse reactions, continued

ADVERSE REACTIONS The following adverse reactions associated with the use of ephedrine sulfate were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Gastrointestinal disorders: Nausea, vomiting Cardiac disorders: Tachycardia, palpitations (thumping heart), reactive hypertension, bradycardia, ventricular ectopics, R-R variability Nervous system disorders: Dizziness Psychiatric disorders: Restlessness Most common adverse reactions during treatment: nausea, vomiting, and tachycardia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Nexus Pharmaceuticals at (855) 642-2594 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: FDA drug label, Nexus Pharmaceuticals, LLC, effective September 16, 2024 (SPL set 14601778-93ac-43ec-b66b-5a942317133f), via openFDA; the full label on DailyMed

What do FAERS reports show?

212 reports list ephedrine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 23 are coded as a death and 51 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 20 reactions below, 3 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)32
  • Off Label Use (a use or a product term, not a reaction)17
  • Drug Abuse15
  • Cardiac Arrest13
  • Overdose (a use or a product term, not a reaction)13
  • Toxicity To Various Agents13
  • Drug Dependence11
  • Respiratory Arrest11
  • Administration Related Reaction10
  • Drug Hypersensitivity10
  • Hypotension (a use or a product term, not a reaction)10
  • No Adverse Event (a use or a product term, not a reaction)10
  • Acute Kidney Injury9
  • Anxiety9
  • Asthenia9
  • Dizziness (named in the label)9
  • Dyspnoea9
  • Pain9
  • Back Pain8
  • Blood Pressure Increased8
  • Fatigue8
  • Loss Of Consciousness8
  • Nausea (named in the label)8
  • Cough7
  • Bradycardia (named in the label)6

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

What next?

Ephedrine: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions