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What the label lists and what reports show

Oxytocin side effects

Oxytocin's FDA label lists its adverse reactions in its own words. FAERS holds 2,981 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 premature baby (206 reports).

  • Generic listed

Check it at the source: the oxytocin FDA label on DailyMed (effective January 12, 2026, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following adverse reactions have been reported in the mother: • Anaphylactic reaction • Postpartum hemorrhage • Cardiac arrhythmia • Fatal afibrinogenemia • Nausea • Vomiting • Premature ventricular contractions • Pelvic hematoma Excessive dosage or hypersensitivity to the drug may result in uterine hypertonicity, spasm, tetanic contraction or rupture of the uterus. The possibility of increased blood loss and afibrinogenemia should be kept in mind when administering the drug. Severe water intoxication with convulsions and coma has occurred, and is associated with a slow oxytocin infusion over a 24-hour period. Maternal death due to oxytocin-induced water intoxication has been reported. …

Source: FDA drug label, Fresenius Kabi USA, LLC, effective January 12, 2026 (SPL set c7fd585a-99b7-4309-b003-a6cbef05372c), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,981 reports list oxytocin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 150 are coded as a death and 887 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, 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.

Reports received each year

The 25 most reported reactions

  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)443
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)432
  • Drug Ineffective (a use or a product term, not a reaction)401
  • Exposure During Pregnancy (a use or a product term, not a reaction)361
  • Premature Baby206
  • Hypotension (named in the label)191
  • Off Label Use (a use or a product term, not a reaction)191
  • Premature Delivery160
  • Postpartum Haemorrhage (named in the label)144
  • Drug Exposure During Pregnancy (a use or a product term, not a reaction)143
  • Maternal Exposure During Delivery (a use or a product term, not a reaction)134
  • Caesarean Section (named in the label)105
  • Low Birth Weight Baby104
  • Nausea (named in the label)96
  • Dyspnoea90
  • Vomiting (named in the label)80
  • Tachycardia77
  • Hypertension (named in the label)69
  • Anaphylactic Reaction (named in the label)66
  • Pain66
  • Pyrexia64
  • Normal Newborn62
  • Live Birth60
  • Small For Dates Baby57
  • Haemoglobin Decreased56

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

What next?

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