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Serophene (Clomiphene Citrate) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS SECTION

Clinical Trial Adverse Events. ClomiPHENE citrate, at recommended dosages, is generally well tolerated.  Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued.  Adverse experiences reported in patients treated with clomiPHENE citrate during clinical studies are shown in Table 2.

Table 2. Incidence of Adverse Events in Clinical Studies (Events Greater than 1%) (n = 8029*)
Adverse Event%
*Includes 498 patients whose reports may have been duplicated in the event totals and could not be distinguished as such.  Also, excludes 47 patients who did not report symptom data.
Ovarian Enlargement13.6
Vasomotor Flushes10.4
Abdominal-Pelvic Discomfort/Distention/Bloating 5.5
Nausea and Vomiting 2.2
Breast Discomfort 2.1
Visual Symptoms:  Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes 1.5
Headache 1.3
Abnormal Uterine Bleeding: Intermenstrual spotting, menorrhagia 1.3

The following adverse events have been reported in fewer than 1% of patients in clinical trials: Acute abdomen, appetite increase, constipation, dermatitis or rash, depression, diarrhea, dizziness, fatigue, hair loss/dry hair, increased urinary frequency/volume, insomnia, light-headedness, nervous tension, vaginal dryness, vertigo, weight gain/loss.

Patients on prolonged clomiPHENE citrate therapy may show elevated serum levels of desmosterol.  This is most likely due to a direct interference with cholesterol synthesis.  However, the serum sterols in patients receiving the recommended dose of clomiPHENE citrate are not significantly altered.  Ovarian cancer has been infrequently reported in patients who have received fertility drugs.  Infertility is a primary risk factor for ovarian cancer; however, epidemiology data suggest that prolonged use of clomiPHENE may increase the risk of a borderline or invasive ovarian tumor.

Postmarketing Adverse Events

The following adverse experiences were reported spontaneously with clomiPHENE citrate.  The cause and effect relationship of the listed events to the administration of clomiPHENE citrate is not known.

Dermatologic: Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritus, urticaria

Central Nervous System: Migraine headache, paresthesia, seizure, stroke, syncope

Psychiatric: Anxiety, irritability, mood changes, psychosis

Visual Disorders: Abnormal accommodation, cataract, eye pain, macular edema, optic neuritis, photopsia, posterior vitreous detachment, retinal hemorrhage, retinal thrombosis, retinal vascular spasm, temporary loss of vision

Cardiovascular: Arrhythmia, chest pain, edema, hypertension, palpitation, phlebitis, pulmonary embolism, shortness of breath, tachycardia, thrombophlebitis

Musculoskeletal: Arthralgia, back pain, myalgia

Hepatic: Transaminases increased, hepatitis

Neoplasms: 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 (hydatiform mole, choriocarcinoma); miscellaneous (melanoma, myeloma, perianal cysts, renal cell carcinoma, Hodgkin’s lymphoma, tongue carcinoma, bladder carcinoma): and neoplasms of offspring (neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia).

Genitourinary: Endometriosis, ovarian cyst (ovarian enlargement or cysts could, as such, be complicated by adnexal torsion), ovarian hemorrhage, tubal pregnancy, uterine hemorrhage.

Body as a Whole: Fever, tinnitus, weakness

Other: Leukocytosis, thyroid disorder

Fetal/Neonatal Anomalies: The following fetal abnormalities have also been reported during postmarketing surveillance: delayed development; abnormal bone development including skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot, and joints, tissue malformations including imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, renal agenesis and dysgenesis, and malformations of the eye and lens (cataract), ear, lung, heart (ventricular septal defect and tetralogy of Fallot), and genitalia; as well as dwarfism, deafness, mental retardation, chromosomal disorders, and neural tube defects (including anencephaly).



REPORTS OF SUSPECTED SEROPHENE SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Serophene. The information is not vetted and should not be considered as verified clinical evidence.

Possible Serophene side effects / adverse reactions in 29 year old female

Reported by a pharmacist from Brazil on 2011-11-04

Patient: 29 year old female

Reactions: Abdominal Discomfort, Hypersensitivity, Nausea, Urinary Tract Infection, Dizziness

Suspect drug(s):
Antibiotics
    Indication: Urinary Tract Infection

Serophene
    Indication: Assisted Fertilisation
    Start date: 2011-10-05
    End date: 2011-10-09



Possible Serophene side effects / adverse reactions in 29 year old female

Reported by a physician from Japan on 2012-06-08

Patient: 29 year old female

Reactions: Intracranial Meningioma Malignant

Adverse event resulted in: death

Suspect drug(s):
Serophene



See index of all Serophene side effect reports >>

Drug label data at the top of this Page last updated: 2006-08-07

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