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Rozerem Side Effects summary
Total Rozerem reports: 1389.Rozerem FDA safety alerts: 2007 .
Reported deaths: 14 Reported hospitalizations: 37.
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Rozerem Side Effects: initial insomnia, middle insomnia, poor quality sleep, somnolence, insomnia, feeling abnormal, nightmare, fatigue, abnormal dreams, nausea, headache,
Rozerem Usage.
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Rozerem Side Effects reported to FDA
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Rozerem Side Effects Report #5531610-6Consumer or non-health professional from UNITED STATES reported ROZEREM problem on July 31, 2007. Female patient, 49 years of age, weighting 145.0 lb, was diagnosed with middle insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abdominal pain, chills, diarrhoea, middle insomnia, pyrexia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with SYNTHROID. Patient recovered.
Rozerem Side Effects Report #5531618-0
ROZEREM problem was reported by a Physician from UNITED STATES on July 31, 2007. Female patient, 92 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: contusion, fall, skin ulcer. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5531619-2
Health Professional from UNITED STATES reported ROZEREM problem on July 31, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abdominal pain, diarrhoea. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5531620-9
ROZEREM problem was reported by a Health Professional from UNITED STATES on July 31, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abdominal pain, diarrhoea. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5531622-2
Health Professional from UNITED STATES reported ROZEREM problem on July 31, 2007. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abdominal pain, diarrhoea. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5531623-4
ROZEREM problem was reported by a Physician from UNITED STATES on Aug 20, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5531630-1
Pharmacist from UNITED STATES reported ROZEREM problem on Sept 25, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: hypersexuality. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5531640-4
ROZEREM problem was reported by a Health Professional from UNITED STATES on Aug 23, 2007. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, poor quality sleep. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with KLONOPIN. Patient recovered.
Rozerem Side Effects Report #5531657-X
Health Professional from UNITED STATES reported ROZEREM problem on Sept 25, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams, poor quality sleep. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5531670-2
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 23, 2007. Female patient, 56 years of age, weighting 135.0 lb, was diagnosed with middle insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: hangover, head discomfort, initial insomnia, middle insomnia, poor quality sleep, tension. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with VITAMIN, FISHLET, COENZYME Q, ALPHA LIPOIC ACID, BABY ASPIRIN, SULFAMETHOXAZOLE. Patient recovered.
Rozerem Side Effects Report #5531682-9
Physician from UNITED STATES reported ROZEREM problem on Aug 23, 2007. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5531689-1
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 24, 2007. Male patient, 61 years of age, weighting 154.0 lb, was diagnosed with initial insomnia, sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: asthenia, hangover, headache, nausea, somnolence. ROZEREM dosage: 8 MG, 1 IN 1 D, PER ORAL. During the same period patient was treated with KLONOPIN. Patient recovered.
Rozerem Side Effects Report #5531701-X
Health Professional from UNITED STATES reported ROZEREM problem on Sept 26, 2007. Female patient, 41 years of age, weighting 128.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: headache, initial insomnia, malaise, vomiting. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with SEROQUEL, MOTRIN, MS CONTIN, XANAX. Patient recovered.
Rozerem Side Effects Report #5531707-0
ROZEREM problem was reported by a Health Professional from UNITED STATES on Sept 07, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: breast discharge, fatigue, somnolence. ROZEREM dosage: unknown. Patient recovered.

Rozerem Side Effects Report #5531874-9
Physician from UNITED STATES reported ROZEREM problem on July 31, 2007. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: dizziness, feeling abnormal, initial insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with BONIVA, VITAMIN. Patient recovered.
Rozerem Side Effects Report #5531876-2
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 03, 2007. Male patient, 59 years of age, weighting 175.0 lb, was diagnosed with middle insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: derealisation, dizziness. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with ALPRAZOLAM, PROVIGIL, LEVOXYL, NIASPAN, PAXIL, METFORMIN, GLIMEPIRIDE, OMEPRAZOLE. Patient recovered.
Rozerem Side Effects Report #5531877-4
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 04, 2007. Male patient, 65 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, back pain, dysuria, gait disturbance, headache, initial insomnia, malaise, muscle spasms, nightmare. ROZEREM dosage: 8 MG, ONCE, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5531881-6
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 06, 2007. Male patient, 76 years of age, weighting 177.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: sluggishness. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5531882-8
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 07, 2007. Female patient, 37 years of age, weighting 132.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: fatigue, initial insomnia, middle insomnia, musculoskeletal disorder, neck pain. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.

Rozerem Side Effects Report #5531883-X
ROZEREM problem was reported by a Physician from UNITED STATES on Aug 07, 2007. Female patient, 49 years of age, was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: anxiety. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with SARAFEM, FLONASE, ALLEGRA. Patient recovered.
Rozerem Side Effects Report #5531884-1
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 08, 2007. Male patient, 59 years of age, weighting 175.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling abnormal, hangover, middle insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with TOPROL, ATIVAN, VYTORIN. Patient recovered.
Rozerem Side Effects Report #5531885-3
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 31, 2007. Female patient, 47 years of age, weighting 140.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, ocular discomfort, sensation of pressure. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5531897-X
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 09, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, malaise. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5531900-7
ROZEREM problem was reported by a Physician from UNITED STATES on Aug 28, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: abnormal dreams. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5531901-9
Physician from UNITED STATES reported ROZEREM problem on Aug 28, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: vaginal haemorrhage. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5531905-6
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 29, 2007. Female patient, 57 years of age, weighting 130.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia, somnolence, therapeutic response increased. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5531906-8
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 30, 2007. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling jittery. ROZEREM dosage: 8 MG, AS REQUIRED, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5531913-5
ROZEREM problem was reported by a Physician from UNITED STATES on Sept 04, 2007. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: nightmare. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5531914-7
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 05, 2007. Female patient, 53 years of age, weighting 170.0 lb, was diagnosed with circadian rhythm sleep disorder and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: feeling abnormal, middle insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with XANAX. Patient recovered.
Rozerem Side Effects Report #5531916-0
ROZEREM problem was reported by a Physician from UNITED STATES on Oct 10, 2007. Male patient, 50 years of age, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: ammonia increased, hallucination. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5532687-4
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 27, 2007. Male patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: depression, somnolence. ROZEREM dosage: 8 MG, QHS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5532689-8
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 28, 2007. Female patient, 70 years of age, weighting 150.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with VASOTEC, ALDOMET. Patient recovered.
Rozerem Side Effects Report #5532690-4
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 31, 2007. Female patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: poor quality sleep. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5532691-6
ROZEREM problem was reported by a Health Professional from UNITED STATES on Aug 23, 2007. Male patient was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: libido decreased. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5532693-X
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 29, 2007. Male patient, 49 years of age, weighting 255.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia, somnolence. ROZEREM dosage: 8 MG, HS, PER ORAL. During the same period patient was treated with OXYCODONE, BENICAR, LEFLUNOMIDE, LEVOTHYROXINE, CLONIDINE, DICLOFENAC, ZOLOFT. Patient recovered.
Rozerem Side Effects Report #5532694-1
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 29, 2007. Female patient, 62 years of age, weighting 108.0 lb, was diagnosed with initial insomnia, middle insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL. Patient recovered.
Rozerem Side Effects Report #5532697-7
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Sept 05, 2007. Male patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: middle insomnia. ROZEREM dosage: 8 MG, HS, PER ORAL ; 12.5 MG, HS, PER ORAL. During the same period patient was treated with AMBIEN. Patient recovered.
Rozerem Side Effects Report #5532699-0
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 28, 2007. Male patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: libido decreased. ROZEREM dosage: unknown. Patient recovered.
Rozerem Side Effects Report #5532710-7
Consumer or non-health professional from UNITED STATES reported ROZEREM problem on Aug 15, 2007. Female patient, 45 years of age, weighting 147.0 lb, was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, musculoskeletal pain, somnolence. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with GEODON, KLONOPIN, PEPCID, CYMBALTA. Patient recovered.
Rozerem Side Effects Report #5532711-9
ROZEREM problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 16, 2007. Female patient was diagnosed with insomnia and was treated with ROZEREM. After drug was administered, patient experienced the following problems/side effects: initial insomnia, malaise, poor quality sleep. ROZEREM dosage: 8 MG, QHS, PER ORAL. During the same period patient was treated with HYDROCHLOROTHIAZIDE, BONIVA. Patient recovered.
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Rozerem Side Effects


