Applies to clomiphene: oral tablets.
Side effects include:
Ovarian enlargement; abdominal or pelvic discomfort including distention, bloating, or pain; hot flushes (flashes).
For Healthcare Professionals
Applies to clomiphene: compounding powder, oral tablet.
General
At recommended doses, this drug is well tolerated. Most side effects have been mild and transient and disappear promptly after treatment has stopped.[Ref]
Genitourinary
Very common (10% or more): Ovarian enlargement (up to 13.6%), vasomotor flushes (10.4%)
Common (1% to 10%): Abdominal/pelvic discomfort/distention/bloating, breast discomfort, uterine bleeding abnormal, intermenstrual spotting, menorrhagia
Frequency not reported: Urinary frequency increased, urinary volume increased, vaginal dryness
Postmarketing reports: Endometriosis, ovarian hemorrhage, tubal pregnancy, uterine hemorrhage, reduced endometrial thickness, ovarian hemorrhage, tubal pregnancy, uterine hemorrhage, endometrial thickness reduced
Fetal/Neonatal Patients:
-Postmarketing reports: Hypospadias, cloacal exstrophy[Ref]
Ocular
Common (1% to 10%): Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes
Postmarketing reports: 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
Fetal/Neonatal Patients:
-Postmarketing reports: Eye malformed, lens malformed/cataract[Ref]
Cardiovascular
Postmarketing reports: Arrhythmia, chest pain, hypertension, palpitation, phlebitis, tachycardia, thrombophlebitis
Fetal/Neonatal Patients:
-Postmarketing reports: Septal heart defect, muscular ventricular septal defect, patent ductus arteriosus, tetralogy of Fallot, coarctation of aorta[Ref]
Endocrine
Postmarketing reports: Thyroid disorder
Fetal/Neonatal Patients:
-Postmarketing reports: Dwarfism[Ref]
Oncologic
Frequency not reported: Ovarian cancer, ovarian tumor
Postmarketing reports: Ovarian cyst, hepatic hemangiosarcoma, liver cell adenoma, hepatocellular carcinoma, fibrocystic disease, breast carcinoma, endometrial carcinoma, astrocytoma, pituitary tumor, prolactinoma, neurofibromatosis, glioblastoma multiforme, brain abscess, ovary (luteoma of pregnancy, dermoid cyst of the ovary, ovarian carcinoma, hydatiform mole, choriocarcinoma, melanoma, myeloma, perianal cysts, renal cell carcinoma, Hodgkin's lymphoma, tongue carcinoma, bladder carcinoma
Fetal/Neonatal Patients:
-Postmarketing reports: Neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia[Ref]
Nervous system
Common (1% to 10%): Headache
Frequency not reported: Dizziness, lightheadedness
Postmarketing reports: Migraine headache, paresthesia, seizure, stroke, syncope
Fetal/Neonatal Patients:
-Postmarketing reports: Neural tube defect, anencephaly, meningomyelocele), microcephaly, hydrocephalus[Ref]
Dermatologic
Frequency not reported: Dermatitis, rash, hair loss/dry hair
Postmarketing reports: Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritus, urticaria[Ref]
Gastrointestinal
Common (1% to 10%): Nausea, vomiting
Frequency not reported: Acute abdomen, constipation, diarrhea
Postmarketing reports: Pancreatitis
Fetal/Neonatal Patients:
-Postmarketing reports: Cleft lip/palate, imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, omphalocele[Ref]
Hematologic
Postmarketing reports: Leukocytosis[Ref]
Hepatic
Postmarketing reports: Increased transaminases, hepatitis[Ref]
Metabolic
Frequency not reported: Appetite increased, serum desmosterol levels increase
Postmarketing reports: Hypertriglyceridemia[Ref]
Musculoskeletal
Postmarketing reports: Arthralgia, back pain, myalgia
Fetal/Neonatal Patients:
-Postmarketing reports: Abnormal bone development, skeletal malformations of skull/face/nasal passages/jaw/hand limb/foot/spine/joints[Ref]
Other
Frequency not reported: Fatigue, vertigo, weight gain, weight loss
Postmarketing reports: Fever, tinnitus, weakness, edema
Fetal/Neonatal Patients:
-Postmarketing reports: Down's syndrome, ear abnormal, deafness[Ref]
Psychiatric
Frequency not reported: Depression, insomnia, nervous tension
Postmarketing reports: Anxiety, irritability, mood changed, psychosis
Fetal/Neonatal Patients:
Postmarketing reports: Intellectual disability[Ref]
Respiratory
Postmarketing reports: Pulmonary embolism, shortness of breath
Fetal/Neonatal Patients:
-Postmarketing reports: Lung tissue malformation[Ref]
Renal
Fetal/Neonatal Patients:
-Postmarketing reports: Renal agenesis, renal dysgenesis[Ref]
