LUPRON: ADVERSE REACTIONS REPORTED

LUPRON: ADVERSE REACTIONS REPORTED
FOR WOMEN

 

265 different adverse reactions are listed in the package insert for Lupron

 

By 1999, the FDA had received over 6,000 adverse reaction reports for Lupron“In an article in the Journal of the American Medical Association, then FDA Commissioner David A. Kessler revealed that ‘only about 1% of serious events are reported to the FDA.'” (1)

 

REPORTING TO THE FDA IS TOTALLY VOLUNTARY:
If your doctor believes/knows that a medical condition was CAUSED by a drug s/he is NOT REQUIRED to report it to the FDA.
Several years ago the American Medical Association fought a hard battle to ensure that reporting to the FDA REMAINS VOLUNTARY. That is, even if the doctor believes/knows that a drug CAUSED a medical problem, the AMA DID NOT WANT doctors to be REQUIRED to report the information to the FDA.

 

The package insert does NOT state that ALL medical problems CAUSED BY LUPRON will GO AWAY when YOU STOP TAKING Lupron

 

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:

  1. in the package insert (*) which can be found in the book the Physicians Desk Reference (PDR) in any library
  2. to the FDA (+) as part of the Spontaneous Reporting System/Division of Epidemiology and Surveillance (MedWatch Report Forms)
  3. 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 | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | R | S | T | U | V | W-Z

 

A Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
Fatigue #
Fever +
Fibrillat(ion) Vent(ricular) +
Fibromyalgia *
Fibro(sis) Lung +
Flatul(ence) +
Flu Syndrome * +
Furunculosis +
G Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
Obstruct(ion) Intest(inal) +
Opthalmitis +
Opthalmologic Disorders *
Osteoporosis +
Otitis Ext(ernal) +
Otitis Media +
Ovarian Cysts #
Ovarian Dis(order) +
Ovulation Fail(ure) +
P Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
Rash * +
Rash Mac(ular) Pap(ular) +
Rash Petech(ia) +
Rash Pust(ular) +
Rash Vesic(ular) Bull(ous) +
React(ion) Aggr(avated) +
React(ion) Aggr(avated) +
Rectal Dis(order) +
Refract Dis(order) +
Respirat(ion) Dis(order) +
Respiratory Disorders +
Retinal Dis(order) +
Rhinitis * +
S Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
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 Reported in
1999 PDR
(Package Insert)
Reported
to the
FDA
Reported
in the
Medical
Literature
WBC [White Blood Cell] Abnormality +
Weight Changes *
Weight Dec(rease) +
Weight Inc(rease) +
Weight Gain/Loss *
Withdrawal Synd(rome) +

REFERENCES