Recommended Topic Related To:

Megestrol Acetate Oral Suspension

"The U.S. Food and Drug Administration today approved Kadcyla (ado-trastuzumab emtansine), a new therapy for patients with HER2-positive, late-stage (metastatic) breast cancer.

HER2 is a protein involved in normal cell growth. It is foun"...

Megestrol Acetate Oral Suspension

SIDE EFFECTS

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 megestrol acetate oral suspension.

ADVERSE EVENTS
% of Patients Reporting

  Trial 1
(N=236)
Trial 2
(N=87)
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
Open Label Trial
1200
N=176
Diarrhea 15 13 8 15 8 16 10
Impotence 13 14 6 14 0 14 17
Rash 19 19 4 12 3 12 16
Flatulence 19 10 1 19 3 10 16
Hypertension 10 10 0 18 0 10 14
Asthenia 13 12 3 16 8 14 15
Insomnia 10 13 4 16 0 10 11
Nausea 19 14 0 15 3 14 15
Anemia 16 13 3 15 0 10 10
Fever 13 16 4 15 3 12 11
Libido Decreased 13 14 0 15 0 12 11
Dyspepsia 10 10 3 13 5 14 12
Hyperglycemia 13 10 6 13 0 10 13
Headache 16 10 1 13 3 10 13
Pain 16 10 0 12 5 16 14
Vomiting 19 13 0 12 3 16 14
Pneumonia 16 12 0 12 3 10 11
Urinary Frequency 10 10 1 12 5 12 11

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 megestrol acetate oral suspension included throm-boembolic phenomena including thrombophlebitis and pulmonary embolism and glucose intolerance (see WARNINGS and PRECAUTIONS sections).

Read the Megestrol Acetate Oral Suspension (megestrol acetate oral suspension) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Pharmacokinetic studies show that there are no significant alterations in pharmacokinetic parameters of zidovudine or rifabutin to warrant dosage adjustment when megestrol acetate is administered with these drugs. The effects of zidovudine or rifabutin on the pharmacokinetics of megestrol acetate were not studied.

Last reviewed on RxList: 6/3/2008
This monograph has been modified to include the generic and brand name in many instances.

A A A

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.


Breast Cancer

Find support and advances in treatment.

Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations