Megace (Megestrol Acetate) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Clinical Adverse Events

Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. These adverse events should be considered by the physician when prescribing MEGACE (megestrol acetate, USP) Oral Suspension.

ADVERSE EVENTS

% of Patients Reporting
	Trial 1 (N=236)				Trial 2 (N=87)		Open Label Trial
Megestrol Acetate, mg/day No. of Patients	Placebo 0 N=34	100 N=68	400 N=69	800 N=65	Placebo 0 N=38	800 N=49	1200 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

Postmarketing reports associated with MEGACE Oral Suspension include thromboembolic phenomena including thrombophlebitis and pulmonary embolism, and glucose intolerance (see WARNINGS and PRECAUTIONS).

REPORTS OF SUSPECTED MEGACE SIDE EFFECTS / ADVERSE REACTIONS

Possible Megace side effects / adverse reactions in 66 year old female

Reported by a physician from United States on 2011-11-15

Patient: 66 year old female weighing 59.4 kg (130.7 pounds)

Reactions: Abdominal Pain, Vomiting, Fatigue, Malaise, Cognitive Disorder, Headache

Adverse event resulted in: hospitalization

Suspect drug(s):
Magnesium Citrate
    Dosage: before surgery
    Administration route: Oral

Carvedilol
    Dosage: 25 mg, 2x/day

Lortab
    Dosage: 1 dosage forms, every 6 hours

Simvastatin
    Dosage: 40 mg, 2x/day
    Administration route: Oral

Pioglitazone Hydrochloride
    Dosage: 30 mg, 1x/day
    Administration route: Oral

Tessalon
    Dosage: 100 mg, 3x/day
    Administration route: Oral

Amlodipine Besylate
    Dosage: 10 mg, 1x/day
    Administration route: Oral

Megace
    Dosage: unk
    Administration route: Oral

Ranitidine
    Dosage: 150 mg, 2x/day

Colace
    Dosage: 100 mg, 2x/day

Fergon
    Dosage: 325 mg, 2x/day
    Administration route: Oral

Sunitinib Malate
    Dosage: 50 mg, 2x/day
    Administration route: Oral

Zofran
    Dosage: 1 dosage forms, every 6 hrs
    Administration route: Oral

Other drugs received by patient: Artificial Tears; Tylenol Extra-Strength; Ciprofloxacin; Aspirin; Actonel

Possible Megace side effects / adverse reactions in 66 year old female

Reported by a physician from United States on 2011-11-23

Patient: 66 year old female weighing 59.4 kg (130.7 pounds)

Reactions: Abdominal Pain, Malaise, Vomiting, Fatigue, Headache, Cognitive Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Radiation
    Dosage: every day, five days a week for three weeks
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-04-08
    End date: 2009-04-01

Simvastatin
    Dosage: 80 mg, daily
    Indication: Product Used FOR Unknown Indication

Study Drug
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Pioglitazone Hydrochloride
    Dosage: 30 mg, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Ranitidine
    Dosage: 300 mg, daily
    Indication: Product Used FOR Unknown Indication

Tessalon
    Dosage: 300 mg, daily
    Indication: Product Used FOR Unknown Indication

Citrate OF Magnesium
    Dosage: before surgery
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Fergon
    Dosage: 650 mg, daily
    Administration route: Oral
    Indication: Iron Deficiency

Megace
    Dosage: 3 df, daily
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Sunitinib Malate
    Dosage: 100 mg, daily
    Indication: Product Used FOR Unknown Indication

Zofran
    Dosage: 1 df, q6h prn
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Colace Capsules
    Dosage: 200 mg, daily
    Indication: Product Used FOR Unknown Indication

Lortab
    Dosage: 1 df, q6h prn
    Indication: Product Used FOR Unknown Indication

Carvedilol
    Dosage: 50 mg, daily
    Indication: Product Used FOR Unknown Indication

Amlodipine
    Dosage: 10 mg, daily
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Aspirin; Cipro; Tylenol (Caplet); Artificial Tears /00445101/; Actonel

Possible Megace side effects / adverse reactions in 66 year old female

Reported by a physician from United States on 2011-11-28

Patient: 66 year old female weighing 59.4 kg (130.7 pounds)

Reactions: Abdominal Pain, Vomiting, Malaise, Fatigue, Cognitive Disorder, Headache

Adverse event resulted in: hospitalization

Suspect drug(s):
Ranitidine

Carvedilol

Fergon
    Administration route: Oral
    Indication: Iron Deficiency

Megace
    Administration route: Oral

Sunitinib Malate

Tessalon

Simvastatin

Pioglitazone HCL
    Administration route: Oral

Zofran
    Dosage: 1 dosage form every 6 hours as needed
    Administration route: Oral

Study Medication

Radiation
    Dosage: qd 5 days a week, x 3weeks external beam 2d
    Start date: 2009-04-08
    End date: 2009-04-01

Citrate OF Magnesium
    Dosage: unknown dose before surgery
    Administration route: Oral

Lortab
    Dosage: i dosage for every 6 hours as needed (5mg/500mg)

Amlodipine

Colace

Other drugs received by patient: Actonel; Artificial Tear; Ciprofloxacin; Extra Strength Tylenol; Aspirin