Drug Safety Information for PITOCIN (Oxytocin)

Safety-related Labeling Changes for OXYTOCIN (OXYTOCIN) Rx Drug: FDA Link

Adverse Drug Reactions for PITOCIN* (Oxytocin)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with PITOCIN
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Caesarean section156
2Hypotension126
3Postpartum haemorrhage116
4Drug ineffective113
5Dyspnoea62
6Uterine atony51
7Maternal drugs affecting foetus51
8Haemoglobin decreased47
9Nausea46
10Vomiting46
11Haemorrhage40
12Pain38
13Cardiac arrest38
14Foetal distress syndrome37
15Heart rate increased36
16Premature baby36
17Tachycardia35
18Disseminated intravascular coagulation35
19Convulsion33
20Bradycardia33

* This side effect also appears in "Top 10 Side Effects of PITOCIN " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking PITOCIN
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Labour induction651
2Product used for unknown indication418
3Induced labour278
4Postpartum haemorrhage242
5Caesarean section95
6Uterine atony80
7Uterine contractions abnormal73
8Delivery59
9Labour stimulation51
10Uterine haemorrhage38

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for PITOCIN

Total Reports Filed with FDA: 6414


Number of FDA Adverse Event Reports by Patient Age for PITOCIN

Total Reports Filed with FDA: 6414*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Oxytocin (Oxytocin, Syntocinon, Pitocin)

Charts are based on 6414 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and PITOCIN Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.