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Claravis Side Effects summary

Total Claravis reports: 514.
Claravis FDA safety alerts: 2007 .
Reported deaths: 17    Reported hospitalizations: 57.
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Claravis Side Effects: unintended pregnancy, abortion induced, treatment noncompliance, pregnancy on oral contraceptive, abortion spontaneous, pregnancy with contraceptive device, depression, suicidal ideation, pregnancy with injectable contraceptive, lip dry, anotia,
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Claravis Side Effects reported to FDA

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Claravis Side Effects Report #5610615-0
Consumer or non-health professional from UNITED STATES reported CLARAVIS problem on Jan 18, 2008. Female patient, 17 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: unintended pregnancy. CLARAVIS dosage: unknown. Patient recovered.



Claravis Side Effects Report #5610620-4
CLARAVIS problem was reported by a Physician from UNITED STATES on Jan 16, 2008. Female patient, 21 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 20 MG, QD, ORAL. Patient recovered.



Claravis Side Effects Report #5610657-5
Consumer or non-health professional from UNITED STATES reported CLARAVIS problem on Jan 14, 2008. Female patient, 31 years of age, weighting 127.0 lb, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: gastroenteritis viral, pregnancy on contraceptive. CLARAVIS dosage: 40 MG, QD, ORAL. Patient recovered.



Claravis Side Effects Report #5610942-7
CLARAVIS problem was reported by a Physician from UNITED STATES on Jan 14, 2008. Male patient, 16 years of age, weighting 215.0 lb, was diagnosed with acne and was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: completed suicide, gun shot wound. CLARAVIS dosage: 20 MG,QD,ORAL; 40 MG, QD, ORAL. Patient died on 01/12/2008.




Claravis Side Effects Report #5610946-4
Physician from UNITED STATES reported CLARAVIS problem on Jan 16, 2008. Male patient, 14 years of age, was diagnosed with acne cystic and was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: abdominal pain, appendicitis, colitis, colon injury. CLARAVIS dosage: 30 MG, BID, ORAL; 30 MG, BID, ORAL. During the same period patient was treated with SINGULAIR, ADVAIR DISKUS, NASONEX. Patient was hospitalized. Patient recovered.



Claravis Side Effects Report #5610963-4
CLARAVIS problem was reported by a Physician from UNITED STATES on Jan 16, 2008. Female patient, 17 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: pregnancy on oral contraceptive, treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 40 MG,QD, ORAL; 40 MG, QD, ORAL; 40 MG, QD, ORAL. Patient recovered.



Claravis Side Effects Report #5613169-8
Physician from UNITED STATES reported CLARAVIS problem on Jan 09, 2008. Female patient, 20 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: headache, treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 40 MG, QD, ORAL. Patient recovered.



Claravis Side Effects Report #5613651-3
CLARAVIS problem was reported by a Physician from UNITED STATES on Jan 09, 2008. Female patient, 25 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: abortion induced, unintended pregnancy. CLARAVIS dosage: 40 MG, BID, ORAL. Patient recovered.



Claravis Side Effects Report #5613658-6
Physician from UNITED STATES reported CLARAVIS problem on Jan 08, 2007. Female patient, 27 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: brain oedema, spinal cord oedema. CLARAVIS dosage: unknown. Patient recovered.




Claravis Side Effects Report #5613659-8
CLARAVIS problem was reported by a Physician from UNITED STATES on Jan 09, 2008. Female patient, 29 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 30 MG, BID, ORAL. Patient recovered.



Claravis Side Effects Report #5614690-9
Physician from UNITED STATES reported CLARAVIS problem on Jan 16, 2008. Female patient, 21 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: unintended pregnancy. CLARAVIS dosage: 20 MG, QD, ORAL. Patient recovered.



Claravis Side Effects Report #5534975-4
CLARAVIS problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 16, 2007. Male patient, 48 years of age, was diagnosed with cyst and was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: abdominal pain lower, abdominal pain upper, flushing, food poisoning, gastrointestinal pain, heart rate increased, nausea, retching, skin fragility. CLARAVIS dosage: 20 MG/DAY, ORAL : 40 MG/DAY, ORAL. During the same period patient was treated with MOBIC. Patient was hospitalized. Patient recovered.



Claravis Side Effects Report #5535028-1
Health Professional from UNITED STATES reported CLARAVIS problem on Nov 16, 2007. Female patient, 18 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: surgery. CLARAVIS dosage: 40 MG, BID, ORAL. Patient recovered.



Claravis Side Effects Report #5535030-X
CLARAVIS problem was reported by a Physician from UNITED STATES on Nov 21, 2007. Female patient, 27 years of age, weighting 125.0 lb, was diagnosed with acne and was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, acne, dry skin, lip dry, unintended pregnancy. CLARAVIS dosage: 20MG, TID, ORAL. Patient recovered.




Claravis Side Effects Report #5535336-4
Consumer or non-health professional from UNITED STATES reported CLARAVIS problem on Nov 19, 2007. Female patient, 41 years of age, was diagnosed with rosacea and was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: anxiety, dizziness, dyspnoea, eructation, gait disturbance, hyperventilation, panic attack, throat tightness. CLARAVIS dosage: 40 MG, QD, ORAL; 40 MG, BID, ORAL. During the same period patient was treated with ALLEGRA, ASPIRIN, VITAMIN E. Patient recovered.



Claravis Side Effects Report #5538363-6
CLARAVIS problem was reported by a Physician from UNITED STATES on Nov 20, 2007. Male patient was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: congenital central nervous system anomaly, congenital choroidal anomaly, congenital hydrocephalus, foetal cardiac disorder, head deformity, low set ears. CLARAVIS dosage: unknown. Patient died on 10/05/2007.



Claravis Side Effects Report #5538364-8
Physician from UNITED STATES reported CLARAVIS problem on Nov 20, 2007. Female patient, 15 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: caesarean section, pregnancy on contraceptive, unintended pregnancy. CLARAVIS dosage: 40 MG, QD, ORAL. Patient recovered.



Claravis Side Effects Report #5538365-X
CLARAVIS problem was reported by a Health Professional from UNITED STATES on Nov 30, 2007. Female patient, 40 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 30 MG, BID, ORAL, 20 MG, ORAL, 40 MG, ORAL. Patient recovered.



Claravis Side Effects Report #5543761-0
Physician from UNITED STATES reported CLARAVIS problem on Nov 21, 2007. Female patient, 17 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 40 MG, BID, ORAL. Patient recovered.




Claravis Side Effects Report #5549812-1
CLARAVIS problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 26, 2007. Female patient, 27 years of age, weighting 115.1 lb, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: benign hydatidiform mole, unintended pregnancy. CLARAVIS dosage: 40 MG, QD, ORAL. During the same period patient was treated with YASMIN. Patient recovered.



Claravis Side Effects Report #5549965-5
Consumer or non-health professional from UNITED STATES reported CLARAVIS problem on Nov 28, 2007. Male patient was diagnosed with acne and was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: crohn's disease, gastrointestinal disorder, inflammatory bowel disease. CLARAVIS dosage: unknown. During the same period patient was treated with SOTRET. Patient recovered.



Claravis Side Effects Report #5550145-8
CLARAVIS problem was reported by a Physician from UNITED STATES on Nov 27, 2007. Female patient, 22 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 40MG,QD,ORAL. Patient recovered.



Claravis Side Effects Report #5550210-5
Health Professional from UNITED STATES reported CLARAVIS problem on Nov 27, 2007. Female patient, 16 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 40MG,QD,ORAL. Patient recovered.



Claravis Side Effects Report #5550255-5
CLARAVIS problem was reported by a Health Professional from UNITED STATES on Nov 27, 2007. Female patient, 24 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: pregnancy test false positive. CLARAVIS dosage: 40 MG,BID,ORAL. Patient recovered.



Claravis Side Effects Report #5550256-7
Physician from UNITED STATES reported CLARAVIS problem on Nov 26, 2007. Female patient, 21 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: abortion induced, treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 40MG,BID,ORAL. Patient recovered.



Claravis Side Effects Report #5550278-6
CLARAVIS problem was reported by a Physician from UNITED STATES on Nov 26, 2007. Female patient, 32 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: abortion induced, treatment failure, unintended pregnancy. CLARAVIS dosage: 40 MG,QD,ORAL. Patient recovered.



Claravis Side Effects Report #5550301-9
Physician from UNITED STATES reported CLARAVIS problem on July 31, 2006. Female patient, 31 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous, treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 40 MG,BID,ORAL. Patient recovered.



Claravis Side Effects Report #5553711-9
CLARAVIS problem was reported by a Physician from UNITED STATES on Nov 30, 2007. Female patient, 19 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: abortion induced, treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 40 MG, QD, ORAL. Patient recovered.



Claravis Side Effects Report #5563405-1
Physician from UNITED STATES reported CLARAVIS problem on Nov 28, 2007. Male patient, 14 years of age, was diagnosed with acne cystic and was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: appendicitis, colitis. CLARAVIS dosage: 30 MG, BID, ORAL. During the same period patient was treated with SINGULAIR, ADVAIR DISKUS, NASONEX. Patient was hospitalized. Patient recovered.



Claravis Side Effects Report #5565792-7
CLARAVIS problem was reported by a Physician from UNITED STATES on Nov 29, 2007. Female patient, 20 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: oral surgery, pregnancy on oral contraceptive. CLARAVIS dosage: 40 MG, BID ORAL. Patient recovered.



Claravis Side Effects Report #5565793-9
Physician from UNITED STATES reported CLARAVIS problem on Nov 29, 2007. Female patient, 23 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: pregnancy on oral contraceptive, treatment noncompliance. CLARAVIS dosage: 60 MG, QD; ORAL. Patient recovered.



Claravis Side Effects Report #5565794-0
CLARAVIS problem was reported by a Physician from UNITED STATES on Dec 07, 2007. Female patient, 29 years of age, weighting 134.9 lb, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: abortion induced, arthralgia, chest discomfort, constipation, dyspepsia, lip dry, oesophageal spasm, unintended pregnancy. CLARAVIS dosage: 40 MG, QD; ORAL, 80 MG, QD; ORAL, 40 MG, QD; ORAL. Patient recovered.



Claravis Side Effects Report #5565795-2
Physician from UNITED STATES reported CLARAVIS problem on Nov 28, 2007. Male patient, 16 years of age, weighting 185.0 lb, was diagnosed with acne and was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: injury. CLARAVIS dosage: 40 MG, BID; ORAL, 40 MG, QD; ORAL. Patient recovered.



Claravis Side Effects Report #5566171-9
CLARAVIS problem was reported by a Health Professional from UNITED STATES on Dec 17, 2007. Male patient, weighting 141.0 lb, was diagnosed with acne cystic and was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: acne cystic, activities of daily living impaired, emotional disorder. CLARAVIS dosage: 40 MG, PO, BID. Patient recovered.



Claravis Side Effects Report #5566523-7
Health Professional from UNITED STATES reported CLARAVIS problem on Nov 30, 2007. Female patient, 22 years of age, weighting 125.0 lb, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: cystitis, treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 40 MG, BID, ORAL. Patient was hospitalized. Patient recovered.



Claravis Side Effects Report #5566524-9
CLARAVIS problem was reported by a Physician from UNITED STATES on Nov 30, 2007. Female patient, 18 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: treatment noncompliance, unintended pregnancy. CLARAVIS dosage: 40 MG, QD, ORAL. Patient recovered.



Claravis Side Effects Report #5568014-6
Physician from UNITED STATES reported CLARAVIS problem on Dec 03, 2007. Female patient, 20 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: unintended pregnancy. CLARAVIS dosage: 10 MG, QD, ORAL; 40 MG, QD, ORAL. Patient recovered.



Claravis Side Effects Report #5568112-7
CLARAVIS problem was reported by a Physician from UNITED STATES on Dec 03, 2007. Male patient, 26 years of age, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: surgery. CLARAVIS dosage: unknown. Patient recovered.



Claravis Side Effects Report #5571063-5
Consumer or non-health professional from UNITED STATES reported CLARAVIS problem on Dec 06, 2007. Female patient, 31 years of age, weighting 127.0 lb, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: gastroenteritis viral, pregnancy on oral contraceptive, treatment noncompliance, unintended pregnancy. CLARAVIS dosage: unknown. Patient recovered.



Claravis Side Effects Report #5571081-7
CLARAVIS problem was reported by a Health Professional from UNITED STATES on Dec 10, 2007. Female patient, 22 years of age, weighting 125.0 lb, was treated with CLARAVIS. After drug was administered, patient experienced the following problems/side effects: cystitis, pregnancy on oral contraceptive, treatment noncompliance. CLARAVIS dosage: 40 MG, BID, ORAL. Patient was hospitalized. Patient recovered.



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