Megace ES Side Effects

Generic Name: megestrol

Please note - some side effects for Megace ES may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Megace ES - for the Consumer

Megace ES Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Megace ES Suspension:

Difficulty sleeping; gas; headache; indigestion.

Seek medical attention right away if any of these SEVERE side effects occur when using Megace ES Suspension:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); calf pain or tenderness; chest pain; coughing up blood; decreased sexual desire or ability; depression; dizziness; increased appetite, thirst, or urination; irregular heartbeat; leg pain; menstrual changes; muscle weakness; nausea; seizures; shortness of breath; signs of infection (eg, fever, chills, sore throat); swelling of the ankles or fingers; unexplained vaginal bleeding; unusual thoughts; unusual weight gain in the face; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Megace ES Side Effects - for the Professional

Megace ES

Serious and Otherwise Important Adverse Reactions

The following serious reactions and otherwise important adverse drug reactions are discussed in greater detail in other sections of the labeling:

• Hypersensitivity [see Contraindications(4.1)]
• Pregnancy [see Contraindications (4.2)]
• Fetal Effects [see Warnings and Precautions (5.2)]
• Thromboembolic Disease [see Warnings and Precautions (5.1)]
• Adrenal Insufficiency [see Warnings and Precaution (5.3)]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial for megestrol acetate oral suspension are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks.

Table 2: Adverse Events

Percent of Patients Reporting Adverse Events
	Trial 1 (N=236)				Trial 2 (N=87)		Open Label Trial
	Placebo				Placebo
Megestrol Acetate mg/day	0	100	400	800	0	800		1200
No. of Patients	N=34	N=68	N=69	N=65	N=38	N=49		N=176
Diarrhea	15	13	8	15	8	6		10
Impotence	3	4	6	14	0	4		7
Rash	9	9	4	12	3	2		6
Flatulence	9	0	1	9	3	10		6
Hypertension	0	0	0	8	0	0		4
Asthenia	3	2	3	6	8	4		5
Insomnia	0	3	4	6	0	0		1
Nausea	9	4	0	5	3	4		5
Anemia	6	3	3	5	0	0		0
Fever	3	6	4	5	3	2		1
Libido Decreased	3	4	0	5	0	2		1
Dyspepsia	0	0	3	3	5	4		2
Hyperglycemia	3	0	6	3	0	0		3
Headache	6	10	1	3	3	0		3
Pain	6	0	0	2	5	6		4
Vomiting	9	3	0	2	3	6		4
Pneumonia	6	2	0	2	3	0		1
Urinary Frequency	0	0	1	2	5	2		1

Adverse events which occurred in 1% to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo.

Body as a Whole - abdominal pain, chest pain, infection, moniliasis and sarcoma

Cardiovascular System - cardiomyopathy and palpitation

Digestive System - constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis

Hemic and Lymphatic System - leukopenia

Metabolic and Nutritional - LDH increased, edema and peripheral edema

Nervous System - paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking

Respiratory System - dyspnea, cough, pharyngitis and lung disorder

Skin and Appendages - alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder

Special Senses - amblyopia

Urogenital System - albuminuria, urinary incontinence, urinary tract infection and gynecomastia.

Postmarketing Experience

Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis, deep vein thrombosis, and pulmonary embolism; and glucose intolerance [see WARNINGS and PRECAUTIONS (5.1, 5.4)].

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Side Effects by Body System - for Healthcare Professionals

Endocrine

Endocrine side effects including cases of new onset diabetes mellitus, exacerbation of preexisting diabetes mellitus, and overt Cushings syndrome have been reported in association of chronic use of megestrol. Adrenal insufficiency has also been reported in patients receiving or being withdrawn from chronic megestrol therapy in both the stressed and non-stressed state. Adrenocorticotropin (ACTH) stimulation testing has revealed the frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic megestrol therapy. Hot flashes have also been reported.

The possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol who presents with signs and/or symptoms suggestive of hypoadrenalism in either the stressed or non-stressed state.

General

General side effects including a significant risk of weight gain (secondary to increased appetite), mood changes, malaise, asthenia, and lethargy have been reported.

Cardiovascular

Cardiovascular side effects including thrombophlebitis, heart failure, edema, deep vein thrombosis, and hypertension have been reported.

Hematologic

Hematologic side effects including a significant risk to develop blood clots have been reported.

Blood clots are particularly a risk in cancer patients and others susceptible to clotting.

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting have been reported.

Genitourinary

Genitourinary side effects including breakthrough menstrual bleeding have been reported.

Respiratory

Respiratory side effects including pulmonary embolism (sometimes fatal) and dyspnea have been reported.

Dermatologic

Dermatologic side effects including alopecia, sweating, and rash have been reported.

Musculoskeletal

Musculoskeletal side effects have included at least two patients with severe osteoporosis complicated by multiple vertebral fractures experienced while the patients were receiving high-dose megestrol therapy.

Nervous system

Nervous system side effects including carpal tunnel syndrome have been reported.

Oncologic

Oncologic side effects including tumor flare (with or without hypercalcemia) have been reported. Long term animal studies have reported an increased risk for both benign and malignant tumors of the breast.

Other

Other side effects including a possible case of megestrol withdrawal syndrome have been reported.

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