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What the label lists and what reports show

Misoprostol side effects

Misoprostol's FDA label lists its adverse reactions in its own words. FAERS holds 9,682 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 haemorrhage (1,260 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the misoprostol FDA label on DailyMed (effective June 4, 2026, Pfizer Laboratories Div Pfizer Inc); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The following have been reported as adverse events in subjects receiving Cytotec: Gastrointestinal In subjects receiving Cytotec 400 or 800 mcg daily in clinical trials, the most frequent gastrointestinal adverse events were diarrhea and abdominal pain. The incidence of diarrhea at 800 mcg in controlled trials in patients on NSAIDs ranged from 14–40% and in all studies (over 5,000 patients) averaged 13%. Abdominal pain occurred in 13–20% of patients in NSAID trials and about 7% in all studies, but there was no consistent difference from placebo. Diarrhea was dose related and usually developed early in the course of therapy (after 13 days), usually was self-limiting (often resolving after 8 days), but sometimes required discontinuation of Cytotec (2% of the patients). Rare instances of profound diarrhea leading to severe dehydration have been reported. …

Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective June 4, 2026 (SPL set 4ab12da7-5731-4e06-bf1c-bc3f2e711f12), via openFDA; the full label on DailyMed

What do FAERS reports show?

9,682 reports list misoprostol among the medicines taken, each a report of something that happened, not proof the medicine caused it; 741 are coded as a death and 2,992 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 18 reactions below, 10 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

  • Haemorrhage1,260
  • Abortion Incomplete1,160
  • Off Label Use (a use or a product term, not a reaction)916
  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)632
  • Pain540
  • Anaemia (named in the label)510
  • Pregnancy (named in the label)449
  • Nausea (named in the label)445
  • Drug Ineffective (a use or a product term, not a reaction)436
  • Vomiting (named in the label)426
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)410
  • Pyrexia407
  • Dizziness (named in the label)396
  • Muscle Spasms352
  • Abdominal Pain (named in the label)348
  • Exposure During Pregnancy (a use or a product term, not a reaction)334
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)316
  • Fatigue (named in the label)288
  • Menorrhagia262
  • Diarrhoea (named in the label)250
  • Malaise230
  • Drug Ineffective For Unapproved Indication (a use or a product term, not a reaction)219
  • Dyspnoea (named in the label)210
  • Foetal Exposure During Delivery207
  • Headache (named in the label)206

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

What next?

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