Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The most frequently reported adverse drug reactions (ADR) during treatment with MENOPUR in clinical trials are ovarian hyperstimulation syndrome (OHSS), abdominal pain, headache, abdominal distension and injection site reactions and injection site pain. None of these ADRs have been reported with an incidence rate of more than 5%.
The table below displays the main ADRs in women treated with MENOPUR in clinical trials distributed by system organ classes (SOCs) and frequency. ADRs seen during post-marketing experience are mentioned with unknown frequency.

System Organ          Common              Uncommon                 Rare        Unknown Class                 (> 1/100 and <      (> 1/1000 and <          (> 1/10)               1/100)                   1/10000 and <
1/1000)
Eye disorders                                                                  Visual disorders Gastrointestinal      Abdominal pain,     Vomiting,
disorders             Abdominal           Abdominal distension,         discomfort,
nausea,             Diarrhoea

General disorders     Injection site      Fatigue and administration    reactions a site condition
Immune system                                                                  Hypersensitivity disorders                                                                      reactions b 
Musculoskeletal &                                                              Musculoskeletal connective tissue                                                              pain c disorders
Nervous system        Headache            Dizziness disorders
Reproductive          OHSS d,             Ovarian cyst, Breast                 Ovarian torsion system disorders      pelvic pain e       complaints f                         d 
Skin and                                                           Acne,       Pruritus, subcutaneous                                                      Rash         Urticaria tissue disorders
Vascular disorders                       hot flush

 a
Most frequently reported injection site reaction was injection site pain.
b
Cases of localised or generalised allergic reactions , including anaphylactic reaction, along with associated symptomatology have been reported rarely.
c
Musculoskeletal pain includes arthralgia, back pain, neck pain and pain in extremities.
d
Gastrointestinal symptoms associated with OHSS such as abdominal distension and discomfort, nausea, vomiting and diarrhoea have been reported with MENOPUR in clinical trials. In cases of severe OHSS ascites and pelvic fluid collection, pleural effusion, dyspnoea, oliguria, thromboembolic events and ovarian torsion have been reported as rare complications.
e
Pelvic pain includes ovarian pain and adnexa uteri pain.
f
Breast complaints include breast pain, breast tenderness, breast discomfort, nipple pain and breast swelling.

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/