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Estradiol Side Effects

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Common Estradiol Side Effects


The most commonly reported Estradiol side effects (click to view or check a box to report):

Application Site Pruritus (133)
Application Site Erythema (124)
Application Site Rash (84)
Hot Flush (63)
Headache (56)
Application Site Irritation (47)
Nausea (35)
Application Site Pain (32)
Pain (28)
Rash (26)
Vomiting (24)
Dizziness (24)
Product Adhesion Issue (24)
Pruritus (24)
Insomnia (23)
Fatigue (23)
Depression (22)
Pregnancy On Oral Contraceptive (22)
Product Substitution Issue (21)
Pulmonary Embolism (20)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Estradiol Side Effects Reported to FDA



Estradiol Side Effect Report#9997698
Stupor, Hot Flush, Insomnia
This is a report of a 79-year-old patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Estradiol (dosage: Unk, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Stupor, Hot Flush, Insomnia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estradiol treatment in patients, resulting in Stupor side effect.
Estradiol Side Effect Report#9995953
Product Adhesion Issue, Hot Flush, Product Physical Consistency Issue, Vulvovaginal Dryness, Skin Disorder, Extra Dose Administered
This report suggests a potential Estradiol Hemihydrate Product Adhesion Issue side effect(s) that can have serious consequences. A 56-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Estradiol Hemihydrate (dosage: 0.075 Mg, Unk) starting 2009. After starting Estradiol Hemihydrate the patient began experiencing various side effects, including: Product Adhesion Issue, Hot Flush, Product Physical Consistency Issue, Vulvovaginal Dryness, Skin Disorder, Extra Dose AdministeredAdditional drugs used concurrently: NA. Although Estradiol Hemihydrate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Adhesion Issue, may still occur.
Estradiol Side Effect Report#9984579
Hot Flush, Irritability
This Hot Flush problem was reported by a pharmacist from US. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 1972 this consumer started treatment with Estradiol Hemihydrate (dosage: 0.1 Mg, Ow). The following drugs were being taken at the same time:
  • Levothyroxine (112 ?g, Qd)
  • Omeprazole (40 Mg, Qd)
When using Estradiol Hemihydrate, the patient experienced the following unwanted symptoms/side effects: Hot Flush, IrritabilityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hot Flush, may become evident only after a product is in use by the general population.
Estradiol Side Effect Report#9933103
Abdominal Adhesions, Cervical Dysplasia, Dyspareunia, Menometrorrhagia, Mood Altered, Adnexa Uteri Pain, Endometriosis, Hot Flush, Abdominal Pain
This Abdominal Adhesions side effect was reported by a physician from US. A 25-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Estradiol (drug dosage: 1 In 1 D), which was initiated on
Oct 17, 2013. Concurrently used drugs:
  • Progestin (progesterone) (1 In 1 D)
  • Lupron Depot (1 M)
  • Flonase
  • Prenatal Vitamins
  • Vitamin C
.After starting to take Estradiol the consumer reported adverse symptoms, such as: Abdominal Adhesions, Cervical Dysplasia, Dyspareunia, Menometrorrhagia, Mood Altered, Adnexa Uteri Pain, Endometriosis, Hot Flush, Abdominal PainThese side effects may potentially be related to Estradiol.
Estradiol Side Effect Report#9893958
Application Site Irritation, Application Site Erythema, Device Material Issue, Product Packaging Quantity Issue, Off Label Use
This is a report of a 77-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Estradiol Hemihydrate (patch) (dosage: 5 Mcg/24hr, Cont, start time: 2000), combined with:
  • Escitalopram (10 Mg, Qd)
  • Levothroid (Unk)
and developed a serious reaction and side effect(s): Application Site Irritation, Application Site Erythema, Device Material Issue, Product Packaging Quantity Issue, Off Label Use after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estradiol Hemihydrate (patch) treatment in female patients, resulting in Application Site Irritation side effect.
Estradiol Side Effect Report#9883845
Product Adhesion Issue, Hot Flush, Product Quality Issue, Product Adhesion Issue, Product Adhesion Issue
This report suggests a potential Estradiol Hemihydrate Product Adhesion Issue side effect(s) that can have serious consequences. A 68-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: hot flush and used Estradiol Hemihydrate (dosage: 0.025 Mg, Ow) starting 201310. After starting Estradiol Hemihydrate the patient began experiencing various side effects, including: Product Adhesion Issue, Hot Flush, Product Quality Issue, Product Adhesion Issue, Product Adhesion IssueAdditional drugs used concurrently: NA. Although Estradiol Hemihydrate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Product Adhesion Issue, may still occur.
Estradiol Side Effect Report#9883832
Fungal Infection
This Fungal Infection problem was reported by a consumer or non-health professional from US. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hot flush. On 1995 this consumer started treatment with Estradiol Hemihydrate (dosage: 0.1 Mg, Ow). The following drugs were being taken at the same time:
  • Vivelle-dot (Unk)
  • Progesterone (100 Mg, Qd)
  • Vitamin D (Unk)
  • B-complex [vitamin B Nos] (Unk)
  • Gluborid (10 Mg, Qd)
When using Estradiol Hemihydrate, the patient experienced the following unwanted symptoms/side effects: Fungal InfectionAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Fungal Infection, may become evident only after a product is in use by the general population.
Estradiol Side Effect Report#9853363
Pulmonary Embolism, Dyspnoea
This Pulmonary Embolism side effect was reported by a health professional from GB. A 46-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Estradiol Valerate (drug dosage: 3 Mg, Qd), which was initiated on NS. Concurrently used drugs:
  • Hydroxychloroquine
  • Mirtazapine
  • Mst Continus
  • Omeprazole
  • Paracetamol
  • Tramadol
  • Seretide
  • Spironolactone
.After starting to take Estradiol Valerate the consumer reported adverse symptoms, such as: Pulmonary Embolism, DyspnoeaThese side effects may potentially be related to Estradiol Valerate. The patient was hospitalized.
Estradiol Side Effect Report#9848656
Fatigue, Emotional Disorder, Sinusitis, Product Substitution Issue
This is a report of a 46-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Estradiol Valerate (dosage: 1 Ml Weekly Into The Muscle, start time:
Jan 12, 2014), combined with: NA. and developed a serious reaction and side effect(s): Fatigue, Emotional Disorder, Sinusitis, Product Substitution Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estradiol Valerate treatment in female patients, resulting in Fatigue side effect.
Estradiol Side Effect Report#9840179
Blood Disorder, Depression, Suicidal Ideation
This report suggests a potential Estradiol Blood Disorder side effect(s) that can have serious consequences. A 29-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: depression and used Estradiol (dosage: 1 Unit) starting
Aug 19, 2013. After starting Estradiol the patient began experiencing various side effects, including: Blood Disorder, Depression, Suicidal IdeationAdditional drugs used concurrently: NA.The patient was hospitalized. Although Estradiol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Disorder, may still occur.
Estradiol Side Effect Report#9821841
Aphagia, Fungal Infection, Mouth Ulceration, Cyst, Weight Decreased, Malaise, Mobility Decreased
This Aphagia problem was reported by a consumer or non-health professional from US. A 43-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201201 this consumer started treatment with Estradiol (dosage: NA). The following drugs were being taken at the same time:
  • Lansoprazole (15 Milligram Daily; 24 Hr, Slow Release)
  • Fluconazole
  • Clindamycin
When using Estradiol, the patient experienced the following unwanted symptoms/side effects: Aphagia, Fungal Infection, Mouth Ulceration, Cyst, Weight Decreased, Malaise, Mobility DecreasedAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Aphagia, may become evident only after a product is in use by the general population.
Estradiol Side Effect Report#9816292
Burning Sensation, Insomnia, Feeling Abnormal
This Burning Sensation side effect was reported by a consumer or non-health professional from US. A 87-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Estradiol (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Estradiol the consumer reported adverse symptoms, such as: Burning Sensation, Insomnia, Feeling AbnormalThese side effects may potentially be related to Estradiol.
Estradiol Side Effect Report#9732184
Viith Nerve Paralysis, Cerebrovascular Accident, Carotid Artery Occlusion, Unresponsive To Stimuli, Convulsion, Oedema
This is a report of a 48-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Estradiol (dosage: 1 Patch, Every 3 Days, Transdermal, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Viith Nerve Paralysis, Cerebrovascular Accident, Carotid Artery Occlusion, Unresponsive To Stimuli, Convulsion, Oedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estradiol treatment in female patients, resulting in Viith Nerve Paralysis side effect.
Estradiol Side Effect Report#9725271
Hypersensitivity
This report suggests a potential Estradiol Hypersensitivity side effect(s) that can have serious consequences. A 52-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: blood oestrogen decreased and used Estradiol (dosage: One Weekly Applied To A Surface?usually The Skin) starting
Sep 23, 2013. After starting Estradiol the patient began experiencing various side effects, including: HypersensitivityAdditional drugs used concurrently: NA. Although Estradiol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypersensitivity, may still occur.
Estradiol Side Effect Report#9632197
Dyskinesia, Therapeutic Response Unexpected, Off Label Use
This Dyskinesia problem was reported by a physician from US. A 53-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: feminisation acquired. On NS this consumer started treatment with Estradiol Hemihydrate (patch) (dosage: 0.1 Mg, Unk). The following drugs were being taken at the same time:
  • Spironolactone (50 Mg, Unk)
  • Carbidopa W/levodopa (25/100)
  • Carbidopa W/levodopa (Reduced To 3 Tabs Daily (nos))
  • Ropinirole (6 Mg, Bid)
  • Ropinirole (8 Mg, Unk)
  • Amantadine (100 Mg, Bid)
When using Estradiol Hemihydrate (patch), the patient experienced the following unwanted symptoms/side effects: Dyskinesia, Therapeutic Response Unexpected, Off Label UseAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dyskinesia, may become evident only after a product is in use by the general population.
Estradiol Side Effect Report#9616796
Vaginal Haemorrhage, Abdominal Pain Lower, Endometrial Hypertrophy, Thrombophlebitis Superficial
This Vaginal Haemorrhage side effect was reported by a consumer or non-health professional from US. A 86-year-old female patient (weight:NA) experienced the following symptoms/conditions: breast cancer recurrent,skin mass.The patient was prescribed Estradiol (watson Laboratories) (drug dosage: 2 Mg, Daily), which was initiated on
Jul 15, 2013. Concurrently used drugs: NA..After starting to take Estradiol (watson Laboratories) the consumer reported adverse symptoms, such as: Vaginal Haemorrhage, Abdominal Pain Lower, Endometrial Hypertrophy, Thrombophlebitis SuperficialThese side effects may potentially be related to Estradiol (watson Laboratories).
Estradiol Side Effect Report#9603148
Premature Baby, Low Birth Weight Baby, Foetal Exposure During Pregnancy
This is a report of a patient (weight: NA) from IL, suffering from the following health symptoms/conditions: NA, who was treated with Estradiol (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Premature Baby, Low Birth Weight Baby, Foetal Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estradiol treatment in patients, resulting in Premature Baby side effect. The patient was hospitalized.
Estradiol Side Effect Report#9602360
Blood Thyroid Stimulating Hormone Increased
This report suggests a potential Estradiol Blood Thyroid Stimulating Hormone Increased side effect(s) that can have serious consequences. A 33-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Estradiol (dosage: 12 Mg, Unk) starting NS. After starting Estradiol the patient began experiencing various side effects, including: Blood Thyroid Stimulating Hormone IncreasedAdditional drugs used concurrently:
  • Progesterone (100 Mg, Unk)
  • Levothyroxine
Although Estradiol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Thyroid Stimulating Hormone Increased, may still occur.
Estradiol Side Effect Report#9563968
Hot Flush, Alopecia, Weight Loss Poor
This Hot Flush problem was reported by a pharmacist from US. A 66-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 1993 this consumer started treatment with Estradiol Hemihydrate (patch) (dosage: 0.025 Mg/d, Unk). The following drugs were being taken at the same time:
  • Fenofibrate (67 Mg, Qd)
  • Vitamin C [ascorbic Acid] (1 G, Qd)
  • Fish Oil (1 G, Qd)
  • Glucosamine/msm (1500 Mg, Qd)
  • Calcium D3 [calcium Carbonate,colecalciferol] (600 Mg, Qd)
When using Estradiol Hemihydrate (patch), the patient experienced the following unwanted symptoms/side effects: Hot Flush, Alopecia, Weight Loss PoorAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Hot Flush, may become evident only after a product is in use by the general population.
Estradiol Side Effect Report#9561181
Acne, Erythema, Pruritus, Pain, Skin Disorder
This Acne side effect was reported by a consumer or non-health professional from US. A 48-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Estradiol Hemihydrate (patch) (drug dosage: 0.05 Mg/d, Ow), which was initiated on 2010. Concurrently used drugs:
  • Nexium (40 Mg, Qd)
  • Progesterone (300 Mg, Qd)
  • Losartan Potassium (25 Mg, Qd)
.After starting to take Estradiol Hemihydrate (patch) the consumer reported adverse symptoms, such as: Acne, Erythema, Pruritus, Pain, Skin DisorderThese side effects may potentially be related to Estradiol Hemihydrate (patch).
Estradiol Side Effect Report#9532177
Application Site Pruritus, Erythema, Multiple Allergies
This is a report of a 53-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Estradiol Hemihydrate (patch) (dosage: 01 Mg, Qd, start time: 200805), combined with:
  • Prometrium (100 Mg, Qd)
  • Fluticasone (Unk Unk, Prn)
and developed a serious reaction and side effect(s): Application Site Pruritus, Erythema, Multiple Allergies after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estradiol Hemihydrate (patch) treatment in female patients, resulting in Application Site Pruritus side effect.
Estradiol Side Effect Report#9516606
Application Site Rash, Dermatitis Contact
This report suggests a potential Estradiol Hemihydrate (patch) Application Site Rash side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Estradiol Hemihydrate (patch) (dosage: Unk) starting
Aug 15, 2013. After starting Estradiol Hemihydrate (patch) the patient began experiencing various side effects, including: Application Site Rash, Dermatitis ContactAdditional drugs used concurrently: NA. Although Estradiol Hemihydrate (patch) demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Application Site Rash, may still occur.
Estradiol Side Effect Report#9476925
Angioedema
This Angioedema problem was reported by a pharmacist from US. A 55-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
May 29, 2013 this consumer started treatment with Estradiol Transdermal System, Usp (dosage: Changed Qweek). The following drugs were being taken at the same time: NA. When using Estradiol Transdermal System, Usp, the patient experienced the following unwanted symptoms/side effects: AngioedemaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Angioedema, may become evident only after a product is in use by the general population.
Estradiol Side Effect Report#9471049
Dysgeusia
This Dysgeusia side effect was reported by a consumer or non-health professional from US. A 74-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Estradiol Hemihydrate (patch) (drug dosage: 0.05 Mg, Qd), which was initiated on
Aug 09, 2013. Concurrently used drugs:
  • Omeprazole (20 Mg, Qd)
.After starting to take Estradiol Hemihydrate (patch) the consumer reported adverse symptoms, such as: DysgeusiaThese side effects may potentially be related to Estradiol Hemihydrate (patch).
Estradiol Side Effect Report#9456435
Underdose, Product Adhesion Issue
This is a report of a 77-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: blood disorder,hot flush, who was treated with Estradiol Hemihydrate (patch) (dosage: 0.075 Mg, Qd, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Underdose, Product Adhesion Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Estradiol Hemihydrate (patch) treatment in female patients, resulting in Underdose side effect.


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The appearance of Estradiol on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.


What are common Estradiol Side Effects for Women?

Women Side EffectsReports
Application Site Pruritus 132
Application Site Erythema 124
Application Site Rash 84
Hot Flush 61
Headache 54
Application Site Irritation 47
Nausea 35
Application Site Pain 32
Pain 27
Rash 26

What are common Estradiol Side Effects for Men?

Men Side EffectsReports
Meningioma 4
Pulmonary Embolism 4
Gynaecomastia 3
Convulsion 2
Dizziness 2
Headache 2
Metabolic Acidosis 2
Off Label Use 2
Premature Baby 2
Septic Shock 2

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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.

    Estradiol reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Estradiol Side Effects

    Did You Have a Estradiol Side Effect?

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    Yes, Minor
    No

    How Effective is Estradiol for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Estradiol Safety Alerts, Active Ingredients, Usage Information

    NDC0009-0271
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDepo-Estradiol
    Nameestradiol cypionate
    Dosage FormINJECTION
    RouteINTRAMUSCULAR
    On market since19790815
    LabelerPharmacia and Upjohn Company
    Active Ingredient(s)ESTRADIOL CYPIONATE
    Strength(s)5
    Unit(s)mg/mL
    Pharma ClassEstradiol Congeners [Chemical/Ingredient],Estrogen [EPC],Estrogen Receptor Agonists [MoA]

    Estradiol Dosage, Warnings, Usage.

    Side Effects reported to FDA: 927

    Estradiol safety alerts: 2014 2012 2010 2006 2005 2003 2002

    Reported deaths: 20

    Reported hospitalizations: 95

    Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw

     

    [Posted 06/06/2012]

    AUDIENCE: Consumer, Pharmacy

    ISSUE: Sandoz notified the public that it issued a voluntary recall of 10 lots of its generic oral contraceptive Introvale in the US, following a recent report of a packaging flaw. A consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled “Week 13”). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week. While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.

    The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012. 

    BACKGROUND: Introvale is an extended-cycle oral contraceptive. Sandoz is not aware of any reports of related adverse events.

    RECOMMENDATION: If a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception and contact their healthcare professional.

    Healthcare professionals and patients are encouraged to report adverse events, side effects, or quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

    • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
    • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

     

    [06/05/2012 - Press Release - Sandoz]

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