Clomid (Clomiphene Citrate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical Trial Adverse Events

CLOMID, 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 = 8029Includes 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.)

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	1.5
Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes
Headache	1.3
Abnormal Uterine Bleeding	1.3
Intermenstrual spotting, menorrhagia

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 CLOMID 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 CLOMID 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 CLOMID. The cause and effect relationship of the listed events to the administration of CLOMID 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, 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 CLOMID SIDE EFFECTS / ADVERSE REACTIONS

Possible Clomid side effects / adverse reactions in 34 year old female

Reported by a consumer/non-health professional from United States on 2012-03-27

Patient: 34 year old female weighing 79.4 kg (174.6 pounds)

Reactions: Hot Flush, Mood Altered, Pain, Vertigo, Pyrexia, Headache

Suspect drug(s):
Clomid

Possible Clomid side effects / adverse reactions in 37 year old female

Reported by a physician from France on 2012-04-11

Patient: 37 year old female

Reactions: Breast Cancer Female, Maternal Exposure Before Pregnancy, Pregnancy

Adverse event resulted in: hospitalization

Suspect drug(s):
Clomid
    Dosage: 100 mg;qd;po
    Administration route: Oral
    Indication: in Vitro Fertilisation
    Start date: 2004-01-01

Puregon (Follitropin Beta /01348901/)
    Dosage: sc;sc
    Indication: in Vitro Fertilisation
    Start date: 2008-04-01

Puregon (Follitropin Beta /01348901/)
    Dosage: sc;sc
    Indication: in Vitro Fertilisation
    Start date: 2005-03-22
    End date: 2005-04-02

Gonadorelin INJ
    Dosage: sc;sc
    Indication: in Vitro Fertilisation
    Start date: 2008-04-01

Gonadorelin INJ
    Dosage: sc;sc
    Indication: in Vitro Fertilisation
    Start date: 2005-03-11
    End date: 2005-04-02

Possible Clomid side effects / adverse reactions in 23 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-09

Patient: 23 year old male

Reactions: Acute Psychosis, Erectile Dysfunction

Suspect drug(s):
Nandrolone Decanoate
    Indication: Muscle Mass
    Start date: 2012-04-01
    End date: 2012-05-01

Clomid
    Administration route: Oral
    Start date: 2012-05-01
    End date: 2012-05-01

Sustanon 100
    Dosage: dose:1 unit(s)
    Indication: Muscle Mass
    Start date: 2012-04-01
    End date: 2012-05-01