Listed below are SOME of the adverse reactions/symptoms/diagnoses that have been reported and/or are associated with the use of Lupron. The adverse reactions/symptoms/diagnoses include those reported: a. in the package insert (*) which can be found in the book the Physicians Desk Reference (PDR) in any library b. to the FDA (+) as part of the Spontaneous Reporting System/Division of Epidemiology and Surveillance (MedWatch Report Forms) c. in the medical literature (#). Only side effects/conditions that have been REPORTED to the FDA, or in the medical literature, or in the package insert are included in the list below. Side effects/conditions that have been ATTRIBUTED to Lupron but have NOT BEEN REPORTED are NOT INCLUDED.
If "#" is the ONLY symbol present, then the symptom/diagnosis was ONLY reported in the medical literature and was NOT reported to the FDA. Even though it is possible to report findings in the medical literature to the FDA this information was NEVER reported to the FDA.

A

13.5% Decrease in Vertebral Trabecular Bone Density (with 6 months of the 3.75 mg per month Depot) * Ab(dominal) Enlargement + Ab(dominal) Synd(rome) Acute + Abortion + Abscess at the Inject(ion) Site * + Abscess Periodontal + Acne * + # Adenoma + Adren(al) Insuffic(iency) + Agitation * + Albuminuria + Alopecia * + Allerg(ic) React(ion) + Altered Hormone Level + Amblyopia + Amenorrhea + Amnesia + Amylase Inc(rease) + ANA + Anaphylactoid Symptoms * Anaphyl(axis) + Androgen-like Effects * Anemia + Anemia Aplastic + Anemia Hemol(ytic) DOP + Anemia Hypochrom(atic) + Anemia Iron Defic(iency) + Angina Pectoris + Angioedema + Anisocoria + Anomaly Congen(ital) + ASD Cardiac Problem [Unspecified] Coarction of the Aorta Enlarged Liver Enlarged Spleen Growth Retardation Hyperplastic Aortic Isthmus Imperforate Anus Rectovaginal Fistula Spinal Fusion Spinal Muscular Atrophy Thirteen Ribs Underdeveloped Brain Anomaly Vascul + Anorexia + Anxiety * + Apnea + Appetite Changes * Appetite Inc(rease) + Applicat(ion) Site React(ion) + Arrhythmia + Arthralgia + Arthralgias/Myalgias # Arthritis + Arthritis Rheu(matoid) + Arthrosis + Ascites + Asthenia * + Asthma * + Ataxia + Atrophy Breast + Atrophy Inject(ion) Site + Atrophy Muscle + Atrophy Skin + AV Block SD +

B

Bilirubinemia + + Bleed(ing) Time Inc(rease) + Blind Color + Blood Test Changes: Albumin Increase * Alkaline Phosphatase Increase * Bilirubin Increase * BUN Increase * Calcium Increase * Creatinine Increase * Glucose Increase * HDL cholesterol Decrease * HDL cholesterol Increase * LDH Increase * LDL cholesterol Increase * LDL/HDL ratio Increase * Neutrophil Decrease * Phosphorus Increase * Platelet Count Decrease * Total Cholesterol Increase * Total Protein Increase * Transamine Increase * Triglyceride Increase * Uric Acid Increase * WBC Decrease * Blurred Vision # Body Odor * + Bone Dis(order) + Bone Fracture Spontaneous + Bradycardia + Brain Synd(rome) Acute + Breast Changes * Breast Disorders * Breast Engorge(ment) + Breast Enlarge(ment) + Breast Fibrocyst(ic) + Breast Pain * Breast Size Reduction * Breast Tenderness * Bronchitis + BUN Inc(rease) +

C

Capill(ary) Fragil(ity) Inc(rease) + Carcinoma [Cancer] + Carcinoma [Cancer] Breast + Carcinoma [Cancer] Cervix + Carcinoma [Cancer] Endometr(ium) + Carcinoma [Cancer] Skin + Carcinoma [Cancer] Thyroid + Cardiomegaly + Cardiovasc(ular) Dis(order) + Cataract + Cellulitis + Cerebrovasc(ular) Accid(ent) + Cerebrovasc(ular) Dis(order) + Cervix Disorder * Chills + Chills/Fever + Chloasma + Cholecyst(itis) + Chondrodyst(rophy) [Dwarfism] + Chromosome Abnormality + Colitis + Colitis Ulcer(ative) + Collagen Dis(order) + Coma + Confus(ion) * + Conjunctivitis * + Constipation + Convuls(ions) + Convul(sions) Grand Mal + Corneal Lesion + Coronary Art(ery) Dis(ease) + Cough Inc(rease) + Cramps Legs + Creatine PK Inc(rease) + Creatinine Inc(rease) + Cyanosis + Cyst + Cystitis +

D

Deaf + Deaf Trans(itory) + Death + Decrease in IQ # Decreased Appetite # Decreased WBC * Dehydration + Delusions * Depersonal(ization) + Depression * + # Depression/Psychotic + Derm(atitis) Contact + Derm(atitis) Exfol(iative) + Derm(atitis) Lichen + Diabetes Mell(itus) + Diarrhea + Diarrhea Bloody + Dizziness * + Dream Abn(ormality) + Drug Inter(action) + Dry Eye + Dry Mouth * + Dysmenorrhea + Dyspareunia + Dyspepsia + Dysphagia + Dyspnea + Dysuria * +

E

Ecchymosis * + ECG Abnorm(ality) + Eczema + Edema * + Edema Face * + Edema General + Edema Inject(ion) Site + Edema Labia + Edema Larynx + Edema Peripheral + Edema Tongue + Effus(ion) Pleural + Electrolyte Deplet(ion) + Embolism Pulmonary * + Emotion(al) Labil(ity) * + Encephalopathy + Endometr(ial) Dis(order) + Enzyme Abnorm(ality) + Eosinophilia + Epiderm(al) Necro(sis) + Epistaxis + Erupt(ion) Fixed + Erythema Mult(iforme) + Erythema Nod(osum) + Esophagitis + ESR [Elevated Sedimentation Rate] Inc(rease) + Euphoria + Exophthalmus + Extrapyr(amidal) Synd(rome) + Extrasystoles + Extrasystoles Vent + Eye Dis(order) +

F

Fatigue # Fever + Fibrillat(ion) Vent(ricular) + Fibromyalgia * Fibro(sis) Lung + Flatul(ence) + Flu Syndrome * + Furunculosis +

G

Gait Abnorm(ality) + Gastritis + Gastro Intestinal Disorder * + Gastroenteritis + GGTP Inc(rease) + G I Disturbances * Gingivitis + Glaucoma + Glossitis * + Glycosuria + Goiter + Gonadotr(opin) Inc(rease) + Gonadotr(opin) Inc(rease) FSH + Gonadot(ropin) Inc(rease) LH + Gout + Granuloma + Guillain Barre Syndrome + Gynecomastia/Breast Disorders *

H

Hair Dis(order) * + Hair Discolor(ation) + Hair Loss # Halitosis + Hallucin(ation) + Hangover + HDL Decrease * Headache * + # Headache Vasc(ular) + Heart Arrest + Heart Failure Right + Hem(e) + Hem(e) G(astro) I(ntestinal) + Hem(e) Gum + Hem(e) Inject(ion) Site + Hem(e) Rectal + Hem(e) Uter(us) + Hem(e) Vaginal + Hematemesis + Hematuria + Hemiplegia + Hepatitis + Hernia + Herpes Simplex + Herpes Zoster + Hirsutism * + Hostility + Hot Flashes * # Hot Flushes # Hyper GUM + Hyperacusis + Hypercalcemi(a) + Hypercholesterem(ia) + Hyperesthesia + Hyperglycem(ia) + Hyperkalem(ia) + Hyperkinesia + Hyperlipem(ia) + Hyperphosphatem(ia) + Hypertens(ion) + Hyperthyr(oid) + Hypertonia + Hyperventilation + Hypesthesia * + Hypoglycem(ia) + Hypoglycem(ic) React(ion) + Hypokinesis + Hyponatrem(ia) + Hypotension * + Hypotension Post(ural) + Hypothyroid + Hysn + Hysn Inject(ion) Site +

I

Inability to Urinate # Incontin(ence) Urin(ary) + Increased Cholesterol Levels * Increased Triglycerides * Induration at the Injection Site * Infarct Myocard(ial) + Infect(ion) + Infect(ion) Bact(erial) + Infect(ion) Urin(ary) Tract + Inject(ion) Site Abscess * + Inject(ion) Site Atrophy + Inject(ion) Site Edema + Inject(ion) Site Fibro(sis) + Inject(ion) Site Hem(e) + Inject(ion) Site Hysn + Injection Site Induration * Inject(ion) Site Inflam(mation) + Inject(ion) Site Mass + Inject(ion) Site Pain + Inject(ion) Site React(ion) * + Insomnia * + # Intracran(ial) Hypertens(ion) + Ischemia Cerebral +

J

Joint Dis(order) * + Joint Pain * # Joint Pain: Elbows # Joint Pain: Costochondrals # Joint Pain: Knees # Joint Pain: Ankles # Joint Pain: Metacarpals # Joint Pain: Metatarsals # Joint Pain: Shoulder #

K

Keratoconjunctivitis + Ketosis + Kidney Calculus + Kidney Fail(ure) + Kidney Func(tion) Abnorm(ality) +

L Reported in 1999 PDR (Package Insert) Reported to the FDA Reported in the Medical Literature Lab Test Abnorm(ality) + Lacrimation Dis(order) + Lactation Fem(ale) * + Laryngismus + Laryngitis * LDH Inc(rease) * + LE [Lupus Erythematous] Synd(rome) + Leukemia + Leukemia: Chronic Monocytic + Leukocytosis + Leukoderma(titis) + Leukopenia + Leukoplakia Genit(al) + Leukoplakia Oral + Leukorrhea + Libido Decrease * + # Libido Increase + # Lipase Inc(rease) + Lipodystrophy + Liver Damage Aggr(avation) + Liver Fail(ure) + Liver Fatty + Liver Func(tion) Abnorm(ality) + Lung Dis(order) + Lung Func(tion) Dec(rease) + Lymphadenopathy * + # Lymphoma Like React(ion) +

M

Malaise + Manic React(ion) + Marrow Depression + Mastalgia # Mastitis + Melanoma Skin + Melanosis + Melena + Memory Disorder * Memory Loss # Memory Loss Short-Term # Meningitis + Menopause + Menorrhagia + Menorrhagia/Hypermenorrhea # Mens(trual) Dis(order) * + Metrorrhagia + Migraine + Monilia(sis) + Monilia(sis) Oral + Mood Lability # Mood Swings * Movement Dis(order) + Multiple Sclerosis + Myalgia * + # Myasthenia + Mydriasis + Myocarditis + Myopathy + Myositis +

N

Nail Disorder * Nausea + Nausea/Vomit * + Nausea/Vomit/Diarr(hea) + Neck Rigid + Necro(sis) + Necro(sis) Bone + Necro(sis) Skin + Necrotizing Myopathy + Neoplasia + Neoplasia Breast + Neopl(asm) + Neopl(asm) Breast + Neopl(asm) CNS [Central Nervous System] + Neopl(asm) Liver + Neopl(asm) Uter(us) + Nephritis + Nephrosis + Nervousness * + Neuralgia + Neuritis + Neuritis/Optic + Neuritis Periph(eral) + Neuromuscular Disorders * Neuropathy + Neurosis + Nocturia + Nodule Skin +

O

Obstruct(ion) Intest(inal) + Opthalmitis + Opthalmologic Disorders * Osteoporosis + Otitis Ext(ernal) + Otitis Media + Ovarian Cysts # Ovarian Dis(order) + Ovulation Fail(ure) +

P

Pain + Pain Abdo(minal) + Pain Back + Pain Bone + Pain Breast + Pain Chest + Pain Chest Substern(al) + Pain Ear * + Pain Eye + Pain General * Pain Inject(ion) Site + Pain Kidney + Pain Muscle * Pain Neck + Pain Pelvic + Pain Urethra + Pallor + Palpitations * + Pancreatitis + Pap Smear Susp + Papilledema + Paralysis * + Paralysis Facial + Paranoid Reaction + Paresthesias * + Paresth(esia) Circumoral + Parathyr(oid) Dis(order) + Parotid Enlarge(ment) + Peripheral Edema # Peripheral Neuritis + Peripheral Neuropathy * Perivascular Dermatitis + Person(ality) Dis(order) * + Petechia + Pharyngitis + Phleb(itis) + Phosphatase Alkaline Inc(rease) + Photophobia + Photosensitivity * + Platelet Abnorm(ality) + Pleural Dis(order) + Pneumonia + Polyuria + Pregnancy Dis(order) + Pregnancy Test False Positive + Pregnancy Unintend(ed) + Prolactin Inc(rease) + Prothrombin Dec(rease) + Pruritus + Pseudotumor Cerebri # Psychosis + Ptosis + Pupil Dilation + Pupil Dis(order) + Purpura + Pyelonephritis * +

R

Rash * + Rash Mac(ular) Pap(ular) + Rash Petech(ia) + Rash Pust(ular) + Rash Vesic(ular) Bull(ous) + React(ion) Aggr(avated) + Rectal Dis(order) + Refract Dis(order) + Respirat(ion) Dis(order) + Respiratory Disorders + Retinal Dis(order) + Rhinitis * +

S

Saliva Inc(rease) + Salivary Gland Enlarge(ment) + Salpingitis + Sarcoma + Scleritis + Seborrhea + Serum Sickness + Sexual Maturity Female Accelerated + SGOT Inc(rease) * + SGPT Inc(rease) + Shock + Shortness of Breath * Sinusitis + Skin Dis(order) + Skin Discolor(ation) + Skin Dry + Skin Reactions * Skin Striae + Sleep Disorder * + Somnolescence + Speech Disorder + Spinal Fracture * Stillbirth + Stomatitis + Stomatitis Aphth(ous) + Stomatitis Ulcer + Stridor + Stupor + Sudden Death + Suicidal Ideation * Suicide Attempt * + Sweat * + Syncope * +

T

Tachycardia * + Tachycardia Supervent(ricular) + Taste Pervers(ion) * + Tendon Dis(order) + Tenesmus + Tenosynovitis + Tenosynovitis-like symptoms * Thinking Abnorm(ality) + Thirst * + Thrombocythemia + Thrombocytopenia + Thrombophleb(itis) + Thrombophleb(itis) Deep + Thromboplastin Dec(rease) + Throm(bosis) + Throm(bosis) Art(erial) + Throm(bus) Coronary + Throm(bosis) Retinal Vein + Throm(bus) + Thyr(oid) Dis(order) + Thyroiditis + Tinnitus + Tooth Caries + Tooth Dis(order) + Tremor + Twitch +

U

Ulcer Duoden(al) + Ulcer Mouth + Ulcer Skin + Ulcer Stomach Hem(e) + Urin(ary) Abnorm(ality) + Urin(ary) Freq(uency) + Urin(ary) Retent(ion) + Urticaria [Hives] * + Uter(ine) Fib(roid) Enlarge(ment) + Uveitis +

V

Vaginal Bleeding * Vaginal Discharge * Vaginal Dryness * # Vaginitis * + Vasc(ular) Dis(order) + Vasc(ular) Dis(order) Peripheral + Vasculitis Vasodilat(ion) + Vertigo + Vein Varicose + Vertigo + Vestibul(ar) Dis(order) + Vis(ual) Field Defect + Vision Abnorm(ality) + Vitreous Dis(order) + Voice Alterat(ion) + Vomiting * + Vulvovaginitis +

W-Z

WBC [White Blood Cell] Abnormality + Weight Changes * Weight Dec(rease) + Weight Inc(rease) + Weight Gain/Loss * Withdrawal Synd(rome) +