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What the label lists and what reports show

Meprobamate side effects

Meprobamate's FDA label lists its adverse reactions in its own words. FAERS holds 1,268 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 toxicity to various agents (323 reports).

  • Generic listed
  • DEA Schedule IV

Check it at the source: the meprobamate FDA label on DailyMed (effective January 10, 2023, Alembic Pharmaceuticals Limited); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Central Nervous System Drowsiness, ataxia, dizziness, slurred speech, headache, vertigo, weakness, paresthesias, impairment of visual accommodation, euphoria, overstimulation, paradoxical excitement, fast EEG activity. Gastrointestinal Nausea, vomiting, diarrhea. Cardiovascular Palpitation, tachycardia, various forms of arrhythmia, transient ECG changes, syncope; also hypotensive crisis (including one fatal case). Allergic or Idiosyncratic Allergic or idiosyncratic reactions are usually seen within the period of the first to fourth dose in patients having had no previous contact with the drug. Milder reactions are characterized by an itchy, urticarial, or erythematous maculopapular rash which may be generalized or confined to the groin. …

Source: FDA drug label, Alembic Pharmaceuticals Limited, effective January 10, 2023 (SPL set a0891a32-105b-48bc-a246-5e179d2e7fa1), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,268 reports list meprobamate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 838 are coded as a death and 239 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 17 reactions below, 1 is 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

  • Toxicity To Various Agents323
  • Drug Abuse160
  • Completed Suicide (an outcome recorded in the report)127
  • Overdose (a use or a product term, not a reaction)121
  • Accidental Overdose (a use or a product term, not a reaction)105
  • Drug Toxicity98
  • Cardiac Arrest95
  • Drug Ineffective (a use or a product term, not a reaction)79
  • Respiratory Arrest79
  • Death (an outcome recorded in the report)77
  • Multiple Drug Overdose (a use or a product term, not a reaction)54
  • Pulmonary Oedema54
  • Dyspnoea51
  • Accidental Death50
  • Cardio-Respiratory Arrest46
  • Pain42
  • Gait Disturbance39
  • Drug Dependence (named in the label)38
  • Sciatica38
  • Condition Aggravated (a use or a product term, not a reaction)35
  • Pulmonary Congestion35
  • Drug Interaction (a use or a product term, not a reaction)33
  • Hand Deformity33
  • Injection Site Reaction33
  • Fall32

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

What next?

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