Drug Safety Information for RITODRINE Hydrochloride (Ritodrine hydrochloride)

Adverse Drug Reactions for RITODRINE Hydrochloride* (Ritodrine hydrochloride)

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 RITODRINE Hydrochloride
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Premature baby53
2Caesarean section36
3Maternal drugs affecting foetus30
4Premature labour22
5Pulmonary oedema16
6Threatened labour14
7Apgar score low14
8Premature rupture of membranes11
9Neonatal respiratory distress syndrome11
10Pyrexia10
11Premature delivery9
12Small for dates baby9
13Hypoxia8
14Anaemia8
15Tachycardia7
16Renal failure acute7
17Dyspnoea7
18Pulmonary hypertension7
19Neonatal disorder7
20Neonatal asphyxia7

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

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

Reason # of FDA Reports
1Threatened labour114
2Product used for unknown indication102
3Premature labour*53
4Tocolysis36
5Uterine contractions abnormal35
6Abortion threatened25
7Foetal cardiac disorder16
8Foetal heart rate decreased15
9Uterine contractions during pregnancy15
10Foetal exposure during pregnancy6

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


Types of Adverse Events for RITODRINE Hydrochloride

Total Reports Filed with FDA: 968


Number of FDA Adverse Event Reports by Patient Age for RITODRINE Hydrochloride

Total Reports Filed with FDA: 968*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Ritodrine hydrochloride (Ritodrine, Pre par, Yutopar)

Charts are based on 968 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 RITODRINE Hydrochloride 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.