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Mitotane adverse events reported to FDA.

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Summary

FDA Adverse Reports: 10. View All

Mitotane FDA safety alerts: No

Reported hospitalizations: 5

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Often additional risks of using a medication, such as Mitotane, become known after product is used by a larger number of patients, for a longer period of time, and by patients with different health characteristics from those studied before drug approval. This page allows You to Find answers and discuss health symptoms with other Mitotane users, Learn more about unwanted side effects & find ways to reduce them. Browse Mitotane Adverse Reports reported to FDA and participate in Mitotane discussion, find alternative treatments and find ways to avoid or reduce risks associated with using Mitotane. You can also Post a question to users community or Ask a Doctor. PatientsVille.com is Your Complete Guide to all common, undocumented and undisclosed side effects associated with drugs and vaccines. Browse More Drug Reports Here: A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z

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Mitotane Adverse Effect Reports (FDA)

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6744462-3 | Abdominal Pain, Alanine Aminotransferase Increased, Fatigue, Gamma-glutamyltransferase Increased, Malaise, Vomiting
on May 25, 2010 Male patient from FRANCE , 67 years of age, was diagnosed with adrenocortical carcinoma and was treated with Mitotane (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal pain (What is abdominal pain?), alanine aminotransferase increased, fatigue, gamma-glutamyltransferase increased, malaise, vomiting. Mitotane dosage: Reduced To 1.5gm. During the same period patient was treated with CORTONE ACETATE (1.25 Df= (1/2+1/2+1/4)) (View Cortone Acetate Review and Cortone Acetate Label ), NITRODERM (View Nitroderm Review and Nitroderm Label ), CORDARONE (View Cordarone Review and Cordarone Label ), COUMADIN (View Coumadin Review and Coumadin Label ), DILATREND (View Dilatrend Review and Dilatrend Label ).

6744461-1 | Abdominal Pain, Alanine Aminotransferase Increased, Fatigue, Gamma-glutamyltransferase Increased, Malaise, Vomiting
Patient was taking Mitotane (View Usage). Patient had the following side effects: abdominal pain (What is abdominal pain?), alanine aminotransferase increased, fatigue, gamma-glutamyltransferase increased, malaise, vomiting on May 25, 2010 from FRANCE Additional patient health information: Male patient , 67 years of age, was diagnosed with adrenocortical carcinoma and. Mitotane dosage: Dose Reduced 2.5mg To 1.5mg Daily.. During the same period patient was treated with CORTONE ACETATE (Frequency=1.25 Dosage Forms(1/2+1/2+1/4)) (View Cortone Acetate Review and Cortone Acetate Label ), NITRODERM (View Nitroderm Review and Nitroderm Label ), CORDARONE (View Cordarone Review and Cordarone Label ), COUMADIN (View Coumadin Review and Coumadin Label ), DILATREND (View Dilatrend Review and Dilatrend Label ).

6527202-2 | Abasia, Asthenia, Neurotoxicity
Adverse event was reported on Dec 29, 2009 by a Male patient taking Mitotane (View Usage) (Dosage: ) was diagnosed with adrenal carcinoma and. Location: FRANCE , 69 years of age, After Mitotane was administered, patient had the following side effects: abasia, asthenia, neurotoxicity. During the same period patient was treated with ASPIRIN (View Aspirin Review and Aspirin Label ), HYDROCORTISONE (View Hydrocortisone Review and Hydrocortisone Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), PARACETAMOL (View Paracetamol Review and Paracetamol Label ), SIMVASTATIN (View Simvastatin Review and Simvastatin Label ). Patient was hospitalized and became disabled.

6526525-0 | Abdominal Pain, Alanine Aminotransferase Increased, Fatigue, Gamma-glutamyltransferase Increased, Malaise, Vomiting
on Dec 29, 2009 Male patient from FRANCE , 67 years of age, was diagnosed with adrenocortical carcinoma and was treated with Mitotane (View Usage). Patient experienced the following unwanted or unexpected effects: abdominal pain (What is abdominal pain?), alanine aminotransferase increased, fatigue, gamma-glutamyltransferase increased, malaise, vomiting. Mitotane dosage: Dose Reduced 2.5mg To 1.5mg Daily.. During the same period patient was treated with CORTONE ACETATE (Frequency=1.25 Dosage Forms(1/2+1/2+1/4)) (View Cortone Acetate Review and Cortone Acetate Label ), NITRODERM (View Nitroderm Review and Nitroderm Label ), CORDARONE (View Cordarone Review and Cordarone Label ), COUMADIN (View Coumadin Review and Coumadin Label ), DILATREND (View Dilatrend Review and Dilatrend Label ).


6515570-7 | Cholangitis Sclerosing, Hepatitis
on Dec 11, 2009 Female patient from UNITED KINGDOM , 62 years of age, was diagnosed with adrenal carcinoma and was treated with Mitotane (View Usage). Patient had the following side effects: cholangitis sclerosing, hepatitis (What is hepatitis?). Mitotane dosage: . During the same period patient was treated with STEROIDS (View Steroids Review and Steroids Label ). Patient was hospitalized and became disabled.

6415578-6 | Abdominal Pain, Alanine Aminotransferase Increased, Fatigue, Gamma-glutamyltransferase Increased, Malaise, Vomiting
Patient was taking Mitotane (View Usage). After Mitotane was administered, patient had the following side effects: abdominal pain (What is abdominal pain?), alanine aminotransferase increased, fatigue, gamma-glutamyltransferase increased, malaise, vomiting on Oct 19, 2009 from FRANCE Additional patient health information: Male patient , 67 years of age, was diagnosed with adrenocortical carcinoma and. Mitotane dosage: Reduced To 1.5gm. During the same period patient was treated with CORTONE ACETATE (1.25 Df= (1/2+1/2+1/4)) (View Cortone Acetate Review and Cortone Acetate Label ), NITRODERM (View Nitroderm Review and Nitroderm Label ), CORDARONE (View Cordarone Review and Cordarone Label ), COUMADIN (View Coumadin Review and Coumadin Label ), DILATREND (View Dilatrend Review and Dilatrend Label ).

6398149-X | Cholangitis Sclerosing, Hepatitis
Adverse event was reported on Oct 01, 2009 by a Female patient taking Mitotane (View Usage) (Dosage: ) was diagnosed with adrenal carcinoma and. Location: FRANCE , 62 years of age, Patient experienced the following unwanted or unexpected effects: cholangitis sclerosing, hepatitis (What is hepatitis?). During the same period patient was treated with STEROIDS (View Steroids Review and Steroids Label ). Patient was hospitalized.

6149153-8 | Encephalopathy
on Mar 30, 2009 Male patient from FRANCE , child 4 years of age, weighting 52.91 lb, was diagnosed with adrenocortical carcinoma, precocious puberty, adrenal insufficiency and was treated with Mitotane (View Usage). Patient had the following side effects: encephalopathy. Mitotane dosage: Dose Increased Gradually By 0.5g/d Up To 5g/d. During the same period patient was treated with LEUPRORELIN (View Leuprorelin Review and Leuprorelin Label ), HYDROCORTISONE (View Hydrocortisone Review and Hydrocortisone Label ).

5771680-3 | Abasia, Asthenia, Neurotoxicity
on Jun 02, 2008 Male patient from FRANCE , 69 years of age, was diagnosed with adrenal carcinoma and was treated with Mitotane (View Usage). After Mitotane was administered, patient had the following side effects: abasia, asthenia, neurotoxicity. Mitotane dosage: . During the same period patient was treated with ASPIRIN (View Aspirin Review and Aspirin Label ), HYDROCORTISONE (View Hydrocortisone Review and Hydrocortisone Label ), OMEPRAZOLE (View Omeprazole Review and Omeprazole Label ), ACETAMINOPHEN (View Acetaminophen Review and Acetaminophen Label ), SIMVASTATIN (View Simvastatin Review and Simvastatin Label ). Patient was hospitalized and became disabled.

5708996-2 | Adrenal Carcinoma, Blister, Disease Progression, Erythema Multiforme, Lip Erosion, Wound Secretion
Patient was taking Mitotane (View Usage). Patient experienced the following unwanted or unexpected effects: adrenal carcinoma, blister, disease progression, erythema multiforme, lip erosion, wound secretion on Apr 16, 2008 from UNITED STATES Additional patient health information: Female patient , 65 years of age, weighting 198.4 lb, was diagnosed with adrenal carcinoma and. Mitotane dosage: 2000mg Qid Po. During the same period patient was treated with DECADRON (View Decadron Review and Decadron Label ), SENOKET (View Senoket Review and Senoket Label ), ENOXAPARIN SODIUM (View Enoxaparin Sodium Review and Enoxaparin Sodium Label ), ZETIA (View Zetia Review and Zetia Label ), FENTANYL CITRATE (View Fentanyl Citrate Review and Fentanyl Citrate Label ), LASIX (View Lasix Review and Lasix Label ), ATARAX (View Atarax Review and Atarax Label ), LISINOPRIL (View Lisinopril Review and Lisinopril Label ). Patient was hospitalized.


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To find out about documented side effects or safety concerns read either the drug label or the drug's package insert. You may also want to speak with your pharmacist or healthcare provider. All medicines have benefits and risks. The risks are the chances that something unwanted or unexpected could happen to you when you use them. You can protect yourself by searching summaries of recent safety alerts, adverse reports. Sometimes there are risks that only come to light after a medical product gets on the market and is used in a larger number of patients, for a longer period of time, and in patients whose health characteristics are different from those of the patients studied before approval.

Be aware of the following potential Mitotane risks to be aware of: 1. Watch for any Serious adverse events, such as life-threatening situation, which can require an admission to hospital or longer-than-expected hospital stay, permanent disability, birth defect, miscarriage, stillbirth, or birth with serious disease requires medical care to prevent permanent damage
2. Any potential Mitotane quality problem: suspected counterfeit product, potentially contaminated product indicated by suspicious odor or unusual color, inaccurate or unreadable product labeling
3. Potential Mitotane use error: mixing up products with similar drug names or packaging, taking wrong dose of a drug because of confusing dosing instructions on label
4. When applicable, Problems with different manufacturer of same medicine: not getting same results from a generic drug as a brand name drug, or from another generic

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Mitotane Reactions
Abasia
Abdominal PainWhat is Abdominal pain?
Adrenal Carcinoma
Alanine Aminotransferase Increased
Asthenia
Blister
Cholangitis Sclerosing
Disease Progression
Encephalopathy
Erythema Multiforme
Fatigue
Gamma-glutamyltransferase Increased
HepatitisWhat is Hepatitis?
Lip Erosion
Malaise
Neurotoxicity
Vomiting
Wound Secretion
Mitotane Side Effects Notice - The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. PatientsVille.com does not provide medical advice, diagnosis or treatment. The information regarding Mitotane adverse reports, reviews and polls contained on PatientsVille.com site has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of adverse drug reactions or for establishing or changing of patient treatments. Thank you for visiting Patientsville.com!