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Review Clemastine Safety Reports submitted to FDA

Total Clemastine reports: 20.
Clemastine FDA safety alerts: No.
Reported deaths: 2    Reported hospitalizations: 5.
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FDA Reported Clemastine Side Effects: anaphylactic reaction, pruritus, confusional state, circulatory collapse, bradycardia, tongue blistering, swollen tongue, swelling, condition aggravated, suicidal ideation, aggression.
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Clemastine Side Effects Report #5671357-9
Physician from GERMANY reported CLEMASTINE problem on Feb 27, 2008. Male patient, 59 years of age, was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: stevens-johnson syndrome, toxic epidermal necrolysis. CLEMASTINE dosage: unknown. During the same period patient was treated with CLEMASTINE FUMARATE, FENISTIL, LORAZEPAM, CALCIUM, CLEMASTINE FUMARATE, PANTOPRAZOLE, VANCOMYCIN, CHLORIDE. Patient was hospitalized. Patient died.

Clemastine Side Effects Report #5622673-8
CLEMASTINE problem was reported by a Consumer or non-health professional from BRAZIL on Jan 25, 2008. Male patient, child 3 years of age, weighting 29.98 lb, was diagnosed with urticaria and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: condition aggravated, mass, oedema peripheral. CLEMASTINE dosage: unknown. During the same period patient was treated with IRON POLYMALTOSE. Patient recovered.

Clemastine Side Effects Report #5632913-7
Physician from JAPAN reported CLEMASTINE problem on Feb 06, 2008. Male patient, 63 years of age, was diagnosed with pruritus and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood bilirubin increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic function abnormal, neoplasm malignant, yellow skin. CLEMASTINE dosage: unknown. Patient recovered.

Clemastine Side Effects Report #5585312-0
CLEMASTINE problem was reported by a Physician from JAPAN on Dec 28, 2007. Male patient, 63 years of age, was diagnosed with pruritus and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, herpes zoster, liver disorder, neoplasm malignant. CLEMASTINE dosage: unknown. Patient recovered.

Clemastine Side Effects Report #5613185-6
Physician from GERMANY reported CLEMASTINE problem on Jan 14, 2008. Female patient, 77 years of age, was diagnosed with nausea, grand mal convulsion, supraventricular tachycardia, asthma and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: stevens-johnson syndrome, toxic epidermal necrolysis. CLEMASTINE dosage: unknown. During the same period patient was treated with METOCLOPRAMIDE, DIAZEPAM, PANTOPRAZOLE, CARBAMAZEPINE, DIGITOXIN, CLONAZEPAM, THEOPHYLLINE, ISOPTIN. Patient was hospitalized. Patient died.

Clemastine Side Effects Report #5579069-7
CLEMASTINE problem was reported by a Physician from NETHERLANDS on Dec 11, 2007. Female patient, 38 years of age, was diagnosed with allergy test and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: feeling of body temperature change, malaise, somnolence, urticaria. CLEMASTINE dosage: 1.5 MG, ONCE/SINGLE, ORAL. Patient was hospitalized. Patient recovered.

Clemastine Side Effects Report #5579095-8
Physician from JAPAN reported CLEMASTINE problem on Dec 11, 2007. Male patient, 63 years of age, was diagnosed with pruritus and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, hepatic function abnormal, yellow skin. CLEMASTINE dosage: unknown. Patient recovered.

Clemastine Side Effects Report #5449492-X
CLEMASTINE problem was reported by a Consumer or non-health professional from BRAZIL on Aug 25, 2007. Female patient, child 3 years of age, was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: condition aggravated, pruritus, swelling, swollen tongue, tongue blistering. CLEMASTINE dosage: 5 ML, QD. Patient recovered.

Clemastine Side Effects Report #5474697-1
Consumer or non-health professional from NETHERLANDS reported CLEMASTINE problem on Jan 19, 2007. Female patient, 44 years of age, weighting 127.9 lb, was diagnosed with dermatitis allergic and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, bradycardia, circulatory collapse. CLEMASTINE dosage: 2 MG, ONCE/SINGLE, PARENTERAL. Patient recovered.

Clemastine Side Effects Report #5383555-2
CLEMASTINE problem was reported by a Physician from SWITZERLAND on June 25, 2007. Female patient, 28 years of age, weighting 112.4 lb, was diagnosed with hypersensitivity and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. CLEMASTINE dosage: 1 MG, ONCE/SINGLE, INTRAVENOUS. During the same period patient was treated with CETIRIZINE. Patient recovered.

Clemastine Side Effects Report #5385516-6
Physician from NETHERLANDS reported CLEMASTINE problem on June 28, 2007. Male patient, 32 years of age, weighting 165.3 lb, was diagnosed with urticaria and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: aggression, suicidal ideation. CLEMASTINE dosage: 1 MG, BID, ORAL. During the same period patient was treated with PAROXETINE. Patient recovered.

Clemastine Side Effects Report #5383555-2
CLEMASTINE problem was reported by a Physician from SWITZERLAND on June 25, 2007. Female patient, 28 years of age, weighting 112.4 lb, was diagnosed with hypersensitivity and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. CLEMASTINE dosage: 1 MG, ONCE/SINGLE, INTRAVENOUS. During the same period patient was treated with CETIRIZINE. Patient recovered.

Clemastine Side Effects Report #5385516-6
Physician from NETHERLANDS reported CLEMASTINE problem on June 28, 2007. Male patient, 32 years of age, weighting 165.3 lb, was diagnosed with urticaria and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: aggression, suicidal ideation. CLEMASTINE dosage: 1 MG, BID, ORAL. During the same period patient was treated with PAROXETINE. Patient recovered.

Clemastine Side Effects Report #5758710-X
CLEMASTINE problem was reported by a Pharmacist from JAPAN on May 22, 2008. Male patient, child 7 years of age, was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: epilepsy. CLEMASTINE dosage: unknown. Patient recovered.

Clemastine Side Effects Report #5765586-3
Pharmacist from JAPAN reported CLEMASTINE problem on May 29, 2008. Male patient, 59 years of age, was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, pyrexia, stomatitis. CLEMASTINE dosage: unknown. During the same period patient was treated with CLARITHROMYCIN, MUCOSTA, ASVERIN, PROCATEROL, SELTEPNON. Patient recovered.

Clemastine Side Effects Report #5771724-9
CLEMASTINE problem was reported by a Pharmacist from JAPAN on June 03, 2008. Male patient, 59 years of age, was diagnosed with respiratory tract infection and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, pyrexia, stomatitis. CLEMASTINE dosage: unknown. During the same period patient was treated with CLARITHROMYCIN, MUCOSTA, ASVERIN, PROCATEROL, SELTEPNON. Patient was hospitalized. Patient recovered.

Clemastine Side Effects Report #5771732-8
Pharmacist from JAPAN reported CLEMASTINE problem on June 04, 2008. Male patient, child 7 years of age, was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: epilepsy. CLEMASTINE dosage: unknown. Patient recovered.

Clemastine Side Effects Report #5694042-6
CLEMASTINE problem was reported by a Pharmacist from JAPAN on Mar 21, 2008. Female patient was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: convulsion. CLEMASTINE dosage: unknown. During the same period patient was treated with ACETAMINOPHEN, LEVOFLOXACIN. Patient recovered.

Clemastine Side Effects Report #5354787-4
Consumer or non-health professional from BRAZIL reported CLEMASTINE problem on May 30, 2007. Male patient, child 2 years of age, weighting 33.07 lb, was diagnosed with rash papular and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: disease progression, erythema, pruritus, rash papular, wound, wound complication, wound haemorrhage. CLEMASTINE dosage: unknown. Patient recovered.

Clemastine Side Effects Report #5141048-1
CLEMASTINE problem was reported by a Physician from JAPAN on Sept 08, 2006. Male patient, 25 years of age, was diagnosed with pruritus and was treated with CLEMASTINE. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, feeling hot, hyperhidrosis, malaise, paraesthesia, pulse absent, shock. CLEMASTINE dosage: 1 MG, ONCE/SINGLE, ORAL. During the same period patient was treated with VEEN D. Patient was hospitalized. Patient recovered.


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stevens-johnson syndrome, toxic epidermal necrolysis, condition aggravated, mass, oedema peripheral, , was diagnosed with urticaria and was diagnosed with pruritus and was diagnosed with pruritus and was diagnosed with nausea, grand mal convulsion, supraventricular tachycardia, asthma and