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PROSTIN E2® (dinoprostone) Adverse Reactions

ADVERSE REACTIONS

The most frequent adverse reactions observed with the use of dinoprostone for abortion are related to its contractile effect on smooth muscle.

In the patients studied, approximately two-thirds experienced vomiting, one-half temperature elevations, two-fifths diarrhea, one-third some nausea, one-tenth headache, and one-tenth shivering and chills.

In addition, approximately one-tenth of the patients studied exhibited transient diastolic blood pressure decreases of greater than 20 mmHg.

Two cases of myocardial infarction following the use of dinoprostone have been reported in patients with a history of cardiovascular disease.

It is not known whether these events were related to the administration of dinoprostone.

Adverse effects in decreasing order of their frequency, observed with the use of dinoprostone, not all of which are clearly drug related include:

Vomiting
Diarrhea
Nausea
Fever
Headache
Chills or shivering
Backache
Joint inflammation or pain new or exacerbated
Flushing or hot flashes
Dizziness
Arthralgia
Vaginal pain
Chest pain
Dyspnea
Endometritis
Syncope or fainting sensation
Vaginitis or vulvitis
Weakness
Muscular cramp or pain
Tightness in chest
Nocturnal leg cramps
Uterine rupture
Breast tenderness
Blurred vision
Coughing
Rash
Myalgia
Stiff neck
Dehydration
Tremor
Paresthesia
Hearing impairment
Urine retention
Pharyngitis
Laryngitis
Diaphoresis
Eye pain
Wheezing
Cardiac arrhythmia
Skin discoloration
Vaginismus
Tension

Post-marketing surveillance

Immune system disorders: Hypersensitivity reactions (e.g., Anaphylactic reaction, Anaphylactic shock, Anaphylactoid reaction).

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