MEGESTROL ACETATE (megestrol acetate)

There are 2 contraindications. Absolute contraindication.

Contraindication List
Lactation
Pregnancy

There are 1 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Adrenocortical insufficiency

There are 4 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Chronic heart failure
Diabetes mellitus
Hypertension
Thromboembolic disorder

There are 22 severe adverse reactions.

More Frequent	Less Frequent
Hypertension Skin rash	Anemia Bullous dermatitis

Rare/Very Rare
Abnormal glucose tolerance Adrenocortical insufficiency Altered mental status Cardiomyopathy Chest pain Deep venous thrombosis Depression Diabetes mellitus Dyspnea Edema Hepatomegaly Hyperglycemia Leukopenia Peripheral edema Pulmonary thromboembolism Seizure disorder Thrombophlebitis Tumor flare reaction

There are 35 less severe adverse reactions.

More Frequent	Less Frequent
Diarrhea Erectile dysfunction Flatulence Insomnia Nausea Vomiting	Acute cognitive impairment Candidiasis Constipation Dyspepsia Fever General weakness Headache disorder Increased urinary frequency Infection Libido changes Sialorrhea Urinary tract infection Xerostomia

Rare/Very Rare
Abnormal vaginal bleeding Acute abdominal pain Alopecia Cough Disturbance in thinking Gynecomastia Hyperhidrosis Hypoesthesia Pain Palpitations Paresthesia Peripheral sensory neuropathy Pharyngitis Pruritus of skin Toxic amblyopia Urinary incontinence

Although there are no adequate and controlled studies to date using megestrol acetate in pregnant women, the drug has been shown to produce fetal harm in rats. Administration of the drug to rats produced decreases in fetal weight and live births and feminization of male fetuses. No teratogenicity studies in animals have been performed using megestrol acetate dosages that are clinically relevant to humans.

Although progestins have been used beginning in the first trimester of pregnancy to prevent habitual abortion, there is no adequate evidence from well-controlled studies to substantiate the efficacy of progestins for these uses during any phase of pregnancy; however, there is evidence of potential adverse effects on the fetus when these drugs are administered during pregnancy. In addition, in most women, the cause of abortion is a defective ovum, which progestins could not be expected to influence. Because of their uterine-relaxant effects, progestins may delay spontaneous abortion of fertilized defective ova.

There is evidence of increased risk of hypospadias in male neonates associated with progestin use during pregnancy; however, there are insufficient data about the risk in female fetuses. Because of increased genital abnormalities caused by progestins in both male and female fetuses, the manufacturer states that megestrol acetate is not recommended during pregnancy. If a woman becomes pregnant while receiving megestrol acetate or is inadvertently exposed to the drug during pregnancy, she should notify her physician and should be advised of the potential risks to the fetus. Women of childbearing potential should be advised not to become pregnant while receiving megestrol acetate therapy, and they should be advised to use an effective form of contraception while receiving the drug.

The manufacturer states that because of the potential for serious adverse reactions to megestrol acetate in nursing infants, women receiving the drug should discontinue nursing.

No enhanced Geriatric Use information available for this drug.