Ovulet Adverse Reactions



Renata Limited


Full Prescribing Info
Adverse Reactions
The incidence and severity of adverse effects of Clomifene citrate tend to be related to the dose used.
Common: Cardiovascular: Syncope.
Dermatologic: Acne, Dermatitis, Dry hair, Erythema, Erythema multiforme, Erythema nodosum, Vasomotor Flushes, Hypertrichosis, Loss of hair, Pruritus, Rash, Urticaria.
Endocrine metabolic: Disorder of thyroid gland, Weight decreased , Weight increased.
Gastrointestinal: Abdominal-pelvic discomfort (distention, bloating), acute abdominal pain, Constipation, Diarrhea, Gastrointestinal tract finding, Increased appetite), nausea and vomiting.
Hepatic: Increased liver enzymes.
Musculoskeletal: Arthralgia, Backache, Myalgia.
Neurologic: Asthenia, Dizziness, Headache, Insomnia, Light-headedness, Migraine, Paresthesia, Unsteady when walking, Vertigo.
Ophthalmic: Eye/vision finding, temporary functional visual loss, Pain in eye, Photopsia.
Otic: Tinnitus.
Psychiatric: Anxiety, Depression, Fatigue, Feeling nervous, Irritability, Mood disorder.
Renal: Polyuria.
Reproductive: Cyst of ovary, Endometriosis, Hyperstimulation of ovaries, Pain of breast.
Urogenital finding: Vaginal dryness.
Other: Fever.
Serious: Cardiovascular: Cardiac dysrhythmia, Chest pain, Edema, Hypertension, Palpitations, Phlebitis, Pulmonary embolism, Tachycardia.
Endocrine metabolic: Gynecomastia.
Gastrointestinal: Pancreatitis, acute.
Hematologic: Leukocytosis, Thrombophlebitis.
Hepatic: Hepatitis, Liver carcinoma.
Neurologic: Cerebrovascular accident, Neoplasm of nervous system, Seizure.
Ophthalmic: Cataract, Macular retinal edema, Optic neuritis, Posterior vitreous detachment, Retinal hemorrhage, Retinal vascular disorder, Thrombosis of retinal artery, Thrombosis of retinal vein.
Psychiatric: Psychotic disorder.
Reproductive: Disorder of menstruation, Ectopic pregnancy, Endometrial carcinoma, Gestational trophoblastic neoplasm, Hemorrhagic cyst of ovary, Hypertrophy of ovary, Neoplasm of ovary, Ovarian cancer, Testicular cancer, Tubal pregnancy, Uterine hemorrhage.
Other: Carcinoma of breast, Fetal neoplasm, Gestational trophoblastic neoplasm, Malignant neoplasm of liver, Neoplasm of breast, Neoplasm of endometrium, Neoplasm of nervous system, Neoplasm of ovary.
Ovarian Enlargement: At recommended dosage, abnormal ovarian enlargement is infrequent, although the usual cyclic variation in ovarian size may be exaggerated. Similarly, cyclic pain (mittelschmerz) may be accentuated. With higher or prolonged dosage, more frequent ovarian enlargement and cyst formation may occur, and the luteal phase of the cycle may be prolonged.
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