If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.
Prostine Side Effects Reported to FDA
Prostine Side Effect Report#9381851 Foetal Distress Syndrome
This is a report of a male patient (weight: NA) from FR, suffering from the following health symptoms/conditions: labour induction, who was treated with Prostine E2 (dosage: 2 Mg, Unk, start time:
Oct 09, 2003), combined with:
and developed a serious reaction and side effect(s): Foetal Distress Syndrome after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prostine E2 treatment in male patients, resulting in Foetal Distress Syndrome side effect. The patient was hospitalized.
This report suggests a potential Prostine E2Postpartum Haemorrhage side effect(s) that can have serious consequences. A 33-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: labour induction and used Prostine E2 (dosage: 2 Mg, Unk) starting
Oct 09, 2003. After starting Prostine E2 the patient began experiencing various side effects, including: Postpartum Haemorrhage, Urinary Tract Infection, Incorrect Dose AdministeredAdditional drugs used concurrently:
The patient was hospitalized. Although Prostine E2 demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Postpartum Haemorrhage, may still occur.
Prostine Side Effect Report#8355514-9 Postpartum Haemorrhage, Maternal Exposure During Pregnancy
This Postpartum Haemorrhage problem was reported by a health professional from Australia. A 33-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 19, 2012 this consumer started treatment with Prostine (dosage: 2 Mg X 2). The following drugs were being taken at the same time:
Syntocinon (10 Iu, Unk)
Oxytocin (1 Iu, Unk)
Syntocinon (40 Iu, Unk)
When using Prostine, the patient experienced the following unwanted symptoms/side effects: Postpartum Haemorrhage, Maternal Exposure During PregnancyAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Postpartum Haemorrhage, may become evident only after a product is in use by the general population.
Prostine Side Effect Report#6566217-5 Angioedema, Urticaria
This Angioedema side effect was reported by a health professional from France. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: induced labour.The patient was prescribed Prostine E2 (drug dosage: 1 Df, Single), which was initiated on
Feb 10, 2009. Concurrently used drugs:
.After starting to take Prostine E2 the consumer reported adverse symptoms, such as: Angioedema, UrticariaThese side effects may potentially be related to Prostine E2.
Prostine Side Effect Report#6525586-2 Chest X-ray Abnormal
This is a report of a male patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Prostine Vr (dosage: 0.2 Ug/kg, Unk, start time:
Nov 04, 2009), combined with: NA. and developed a serious reaction and side effect(s): Chest X-ray Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Prostine Vr treatment in male patients, resulting in Chest X-ray Abnormal side effect. The patient was hospitalized.
The appearance of Prostine on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.
Why Your Notes are Important
Your notes could be helpful in several ways:
You can use them to remind you of details that may alert your health care professional(s) to a problem
You will have a record to refer to in the future, in case you are ever prescribed the same medicine again
You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.
Medicine Name and Dosage:
Date & Time
Other Medicine(s) or Treatment(s)
Scale: 1 = very mild to 10 = very bad
Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Prostine reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.