"Oct. 20, 2012 -- Babies conceived with the help of high-tech fertility treatments such as in vitro fertilization (IVF) have an increased risk for birth defects, a new study shows.
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Clomid Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Clomid (clomiphene citrate) is a nonsteroidal, ovulatory stimulant used to treat ovulatory dysfunction and polycystic ovary syndrome in women who, after other reasons for pregnancy failure have been ruled out, desire pregnancy and follow additional instructions that make pregnancy more likely to occur with this drug use (see below about dosage and use). In addition, these women and their sperm donors usually need to undergo a number of tests scheduled by their OB-GYN doctor before this drug is started. Generic Clomid is available under many names but the generic name is clomiphene citrate. Common side effects of Clomid may be abnormal vaginal bleeding, breast discomfort, headache, and GI symptoms of nausea and vomiting.
Clomid is available in 50 mg tablets. Treatment of the selected patient should begin with a low dose, 50 mg daily (1 tablet) for 5 days; dose changes are made by the treating physician. The first dose should occur on the 5th day of the female's ovulatory cycle and then subsequent doses at about the same time of day for a total of 5 days. Patients should be familiar with their ovulatory cycle so that properly timed coitus and ovulation stimulated by the drug occur. Long term therapy (past 6 cycles) is not recommended to avoid possible increases in cancer risk. Serious side effects of Clomid include shortness of breath, seizures, stroke, chest pain, vision changes, GI symptoms of pain and swelling. Ovarian hyperstimulation syndrome may occur (ovarian enlargement, severe GI symptoms, abdominal swelling, shortness of breath, pleural effusions, decreased urination). Patients should seek medical care if these serious symptoms develop. This drug is not for use in males or pediatric patients; studies on its excretion in breast milk have not been done.
Our Clomid Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Clomid in Detail - Patient Information: Side Effects
Stop taking clomiphene and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).
The ovarian hyperstimulation syndrome (OHSS) has been reported to occur in patients receiving clomiphene. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these side effects.
Other side effects may also occur. Notify your doctor if you experience
- ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;
- nausea, vomiting, or diarrhea;
- breast tenderness or discomfort;
- blurred vision or other visual disturbances;
- headache; or
- abnormal uterine bleeding.
Clomiphene may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Clomid (Clomiphene) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Clomid Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Vision changes (e.g., blurred vision, seeing spots or flashes) may sometimes occur during clomiphene treatment, especially if you are exposed to bright light. These side effects usually go away a few days or weeks after treatment is stopped. However, in rare cases, vision changes may be permanent. Tell your doctor immediately if any of the following occur: vision problems/changes, eye pain.
Tell your doctor immediately if any of these unlikely but serious side effects occur: abnormal vaginal bleeding, mental/mood changes.
This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. This may occur during therapy or after treatment has been stopped. Seek immediate medical attention if you develop any of the following side effects: severe pain/swelling in the lower abdomen (pelvic) area, sudden/rapid weight gain, nausea/vomiting, diarrhea, shortness of breath, change in the amount of urine, pain/redness/swelling of the legs, chest pain, fast/irregular heartbeat.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Clomid (Clomiphene)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Clomid FDA Prescribing Information: Side Effects
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 = 8029*)
|Nausea and Vomiting||2.2|
|Visual Symptoms Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes||1.5|
|Abnormal Uterine Bleeding Intermenstrual spotting, menorrhagia||1.3|
|*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.|
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 reactions have been identified during post approval use of Clomid. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole: Fever, tinnitus, weakness
- Abnormal bone development: skeletal malformations of the skull, face, nasal passages, jaw, hand, limb (ectromelia including amelia, hemimelia, and phocomelia), foot (clubfoot), spine, and joints
- Cardiac abnormalities: septal heart defects, muscular ventricular septal defect, patent ductus arteriosus, tetralogy of Fallot, and coarctation of the aorta
- Chromosomal disorders: Downs syndrome
- Ear abnormalities and deafness
- Gastrointestinal tract abnormalities: cleft lip and palate, imperforate anus, tracheoesophageal fistula, diaphragmatic hernia, omphalocele
- Genitalia abnormalities: hypospadias, cloacal exstrophy
- Lung tissue malformations
- Malformations of the eye and lens (cataract)
- Neoplasms: neuroectodermal tumor, thyroid tumor, hepatoblastoma, lymphocytic leukemia
- Nervous system abnormalities: neural tube defects (anencephaly, meningomyelocele), microcephaly, and hydrocephalus
- Renal abnormalities: renal agenesis and renal dysgenesis
- Others: dwarfism, mental retardation
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)
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 or prolonged loss of vision, possibly irreversible.
Other: Leukocytosis, thyroid disorder
Drug Abuse And Dependence
Tolerance, abuse, or dependence with CLOMID has not been reported.
Read the entire FDA prescribing information for Clomid (Clomiphene) »
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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