Pregina Adverse Reactions

The incidence and severity of adverse effects due to clomifene citrate therapy are usually related to the dose and duration of use. The most frequently reported adverse effects with clomifene citrate include ovarian enlargement or cyst formation and vasomotor symptoms such as hot flushes.
Neoplasms benign, malignant and unspecified (including cysts and polyps): Liver (hepatic hemangiosarcoma, liver cell adenoma, hepatocellular carcinoma); breast (fibrocystic disease, breast carcinoma); endometrium (endometrial carcinoma); nervous system (astrocytoma, pituitary tumor, prolactinoma, neurofibromatosis, glioblastoma multiforme, brain abscess); ovary (luteoma of pregnancy, dermoid cyst of the ovary, ovarian carcinoma); trophoblastic (hydatidiform mole, choriocarcinoma); miscellaneous (melanoma, myeloma, perianal cyst, renal cell carcinoma, hodgkin's lymphoma, tongue carcinoma, bladder carcinoma); neoplasms of offspring (neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia); isolated reports of endocrine-related or dependent tumors/neoplasms or their aggravation.
Blood and lymphatic system disorders: Leukocytosis.
Endocrine disorders: Thyroid disorder.
Metabolism and nutrition disorders: Hypertriglyceridemia (with or without pancreatitis), increased appetite, weight gain, weight loss.
Psychiatric disorders: Anxiety, depression, disorientation, nervous tension, insomnia, mood disturbances (including mood altered, mood swings and irritability), nervousness, psychotic reactions including paranoid psychosis.
Nervous system disorders: Cerebral thrombosis, cerebrovascular accident, convulsions, dizziness, headache, lightheadedness, migraine headache, neurological impairment, paresthesia, seizures, speech disturbance, stroke, syncope/fainting, vertigo.
Eye disorders: Visual symptoms (blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes), abnormal accommodation, cataract, eye pain, macular edema, optic neuritis, photopsia, posterior vitreous detachment, retinal hemorrhage, retinal thrombosis, retinal vascular spasm; temporary or prolonged loss of vision, possibly reversible; reduced visual acuity.
Ear and labyrinth disorders: Tinnitus.
Cardiac disorders: Arrythmia, chest pain, edema, palpitation, pulmonary embolism, shortness of breath, tachycardia.
Vascular disorders: Hypertension, phlebitis, thrombophlebitis.
Gastrointestinal disorders: Abdominal-pelvic discomfort (distention, bloating, pain or soreness), acute abdomen, constipation, diarrhea, nausea, pancreatitis, vomiting.
Hepatobiliary disorders: Ascites, hepatitis, infectious hepatitis, jaundice; increased levels of transaminases.
Skin and subcutaneous tissue disorders: Acne, allergic reaction, dermatitis/allergic dermatitis, alopecia, angioneurotic edema, ecchymosis, erythema, erythema multiforme, erythema nodosum, hair loss/dry hair, hypertrichosis, pruritus, rash, urticaria.
Musculoskeletal and connective tissue disorders: Arthralgia, back pain, myalgia, myopathy.
Renal and urinary disorders: Increased urinary frequency/volume.
Pregnancy, puerperium and perinatal conditions: Ectopic pregnancy, heterotopic pregnancy, multiple pregnancies (but rarely more than twins). tubal pregnancy.
Reproductive system and breast disorders: Abnormal uterine bleeding (intermestrual spotting, menorrhagia), breast discomfort, breast soreness, breast tenderness, cyclic ovarian pain (mittelschmerz), endometriosis. exacerbation of pre-existing endometriosis, ovarian cysts (ovarian enlargement or cysts could, such as, be complicated by adnexal torsion), ovarian hemorrhage, ovarian hyperstimulation syndrome, uterine hemorrhage, vaginal dryness; reduced endometrial thickness.
Congenital, familial and genetic disorders: Congenital heart lesions, Down's syndrome, neural tube defects, club foot, congenital gut lesions, hypospadias, microcephaly, harelip and cleft palate, congenital hip, hemangioma, undescended testes, polydactyl, conjoined twins with teratomatous malformation, patent ductus arteriosus, amaurosis (blindness), arteriovenous fistula, inguinal hernia, umbilical hernia, syndactyly, pectus excavatum, myopathy, dermoid cyst of scalp, omphalocele, spina bifida occulta, ichthyosis, persistent lingual frenulum, and multiple somatic defect.
General disorders and administration site conditions: Fatigue, fever, weakness.
Investigations: Administration of clomifene resulted in retention of sulfobromophthalein (BSP) in patients whom BSP is measured. Retention was usually minimal unless associated with prolonged continuous administration or with apparently unrelated liver disease.
Clomifene has not shown cause significant abnormality in hematologic or renal tests, in protein bound iodine or in serum cholesterol levels.