SIDE EFFECTS
Clinical Events
Trial Adverse: Clomiphene citrate Tablets USP 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
|
%
|
| Ovarian
Enlargement |
13.6
|
| Vasomotor
Flushes |
10.4
|
| 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
|
Includes 495 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.
The following adverse events have been reported in fewer
than 1% of patients in clinical trails: 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 tablets USP therapy
may show elevated serum levels of desmoschol. This is most
likely due to a direct interference with cholesterols synthesis.
However, the serum sterols in patients receiving the recommended
dose of clomiphene citrate tablets USP 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 citrate tablets
USP may increase the risk of a borderline or invasive ovarian
tumor.
Postmarketing Adverse Events
The following adverse experiences were reported
spontaneously with clomiphene citrate tablets USP. The cause
and effect relationship of the listed events to the administration
of clomiphene citrate tablets USP is not known.
Dermatologic: Acne, allergic reaction,
erythema, erythema multiforme, erythema nodosum, hypertrichosis,
pruritus.
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 abcess);
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, th roid disorder.
Fetal/Neoastal Anomalies
The following fetal abnormalities have also
been reported 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 t.b.
defects (including anencephaly).
DRUG ABUSE AND DEPENDENCE
Tolerance, abuse, or dependence with clomiphene
citrate tablets USP has not been reported.
DRUG INTERACTIONS
Drug interactions with clomiphene citrate tablets
USP have not been documented.
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