Adverse reactions : תופעות לוואי

4.8 Undesirable effects

The frequencies of occurrence of side effects are classified as follows: Very common (≥ 1/10)
Common (≥ 1/100 to < 1/10)
Uncommon (≥ 1/1,000 to < 1/100)
Rare (≥ 1/10,000 to < 1/1,000)
Very rare (< 1/10,000)
Not known (cannot be estimated from the available data)

Infections and infestations
Common:
- Infection following abortion. Suspected or confirmed infections (endometritis, pelvic inflammatory disease) have been reported in less than 5% of women.
Very rare:
- Very rare cases of serious or fatal toxic and septic shock (caused by Clostridium sordellii or Escherichia coli), which can be with or without fever or other obvious symptoms of infection, have been reported after medical abortion with the use of 200 mg mifepristone followed by non authorised vaginal or buccal administration of misoprostol tablets for oral use. Clinicians should be aware of this potentially fatal complication (see section 4.4. – special warnings and special precautions for use).


Nervous system disorders
Rare:
- Headache
Vascular disorders
Uncommon:
- Hypotension (0.25%)


Gastrointestinal disorders
Very common:
- Nausea, vomiting, diarrhoea (these gastro intestinal effects related to prostaglandin use are frequently reported).

Common:
- Cramping, light or moderate.

Skin and subcutaneous tissue disorders
Uncommon
- Hypersensitivity: skin rashes uncommon (0.2%).

Rare
- Single cases of urticaria, erythroderma, erythema nodosum, toxic epidermal necrolysis have also been reported.

Very rare:
- Angioedema
Not known
- Acute generalised exanthematous pustulosis


Reproductive system and breast disorders

Very common:
- Very common uterine contractions or cramping (10 to 45%) in the hours following prostaglandin intake.
Common:
- Heavy bleeding occurs in about 5% of the cases and may require hemostatic curettage in up to 1.4% of the cases.

Rare:
- During induction of second trimester termination of pregnancy or labour induction for foetal death in utero during the third trimester, uterine rupture has been uncommonly reported after prostaglandin intake. The reports occurred particularly in multiparous women or in women with a caesarean section scar.

General disorders and administration site conditions

Rare:
- Malaise, vagal symptoms (hot flushes, dizziness, chills), fever.