Drug information for PARAGARD T 380A

Form	Dosage	Status	Therapeutic Equivalence	Active Ingred	Ref.	Sponsor	Document
INTRAUTERINE DEVICE; INTRAUTERINE	309MG/COPPER	Prescription	(Reference Drug)	COPPER	Copper	DURAMED RES	18680 2011-02-15 Review 2005-09-08 Label 2005-09-08 Letter 2003-05-29 Letter 2003-04-30 Label

Drug Adverse Effects information for PARAGARD T 380A

Role code	Indications	Reaction	# Reports
PS	CONTRACEPTION	ABDOMINAL ADHESIONS	1
PS	CONTRACEPTION	ABDOMINAL DISTENSION	1
PS	CONTRACEPTION	ABDOMINAL PAIN	12
PS	CONTRACEPTION	ABDOMINAL PAIN LOWER	2
PS	CONTRACEPTION	ABDOMINAL PAIN UPPER	2
PS	CONTRACEPTION	ABORTION	1
PS	CONTRACEPTION	ABORTION SPONTANEOUS	20
PS	CONTRACEPTION	ABORTION SPONTANEOUS COMPLETE	1
PS	CONTRACEPTION	AMENORRHOEA	1
PS	CONTRACEPTION	AMNIORRHEXIS	1
PS	CONTRACEPTION	ANXIETY	1
PS	CONTRACEPTION	ARTHRALGIA	1
PS	CONTRACEPTION	ASTHENIA	1
PS	CONTRACEPTION	AUTOIMMUNE DISORDER	1
PS	CONTRACEPTION	BACK PAIN	2
PS	CONTRACEPTION	BLISTER	1
PS	CONTRACEPTION	BREAST TENDERNESS	1
PS	CONTRACEPTION	CELLULITIS	1
PS	CONTRACEPTION	CERVIX INFLAMMATION	1
PS	CONTRACEPTION	CHILLS	2
PS	CONTRACEPTION	COLITIS	2
PS	CONTRACEPTION	COMPLICATION OF DEVICE INSERTION	1
PS	CONTRACEPTION	COMPLICATION OF DEVICE REMOVAL	5
PS	CONTRACEPTION	CYSTITIS	1
PS	CONTRACEPTION	DECREASED APPETITE	1
PS	CONTRACEPTION	DEEP VEIN THROMBOSIS	1
PS	CONTRACEPTION	DEVICE BREAKAGE	15
PS	CONTRACEPTION	DEVICE DISLOCATION	42
PS	CONTRACEPTION	DEVICE EXPULSION	17
PS	CONTRACEPTION	DISCOMFORT	1
PS	CONTRACEPTION	DIZZINESS	2
PS	CONTRACEPTION	DRUG INEFFECTIVE	34
PS	CONTRACEPTION	DYSFUNCTIONAL UTERINE BLEEDING	1
PS	CONTRACEPTION	DYSMENORRHOEA	2
PS	CONTRACEPTION	DYSPAREUNIA	2
PS	CONTRACEPTION	ECTOPIC PREGNANCY	5
PS	CONTRACEPTION	ECTOPIC PREGNANCY WITH INTRAUTERINE DEVICE	3
PS	CONTRACEPTION	ENDOMETRITIS	1
PS	CONTRACEPTION	FALLOPIAN TUBE DISORDER	2
PS	CONTRACEPTION	FATIGUE	4
PS	CONTRACEPTION	FOETAL GROWTH RESTRICTION	1
PS	CONTRACEPTION	FUNGAL INFECTION	1
PS	CONTRACEPTION	GALLBLADDER DISORDER	1
PS	CONTRACEPTION	GASTROENTERITIS	1
PS	CONTRACEPTION	GENITAL DISCHARGE	1
PS	CONTRACEPTION	HAEMORRHAGE	4
PS	CONTRACEPTION	HEADACHE	1
PS	CONTRACEPTION	HYPERTENSION	1
PS	CONTRACEPTION	HYPERVENTILATION	1
PS	CONTRACEPTION	HYPOMENORRHOEA	1
PS	CONTRACEPTION	INFECTION	1
PS	CONTRACEPTION	INFECTIOUS PERITONITIS	1
PS	CONTRACEPTION	INTESTINAL PERFORATION	1
PS	CONTRACEPTION	INTRA-UTERINE DEATH	1
PS	CONTRACEPTION	KIDNEY INFECTION	2
PS	CONTRACEPTION	LABORATORY TEST ABNORMAL	1
PS	CONTRACEPTION	LACTIC ACIDOSIS	1
PS	CONTRACEPTION	LOSS OF CONSCIOUSNESS	2
PS	CONTRACEPTION	LOSS OF LIBIDO	1
PS	CONTRACEPTION	MATERNAL EXPOSURE DURING PREGNANCY	1
PS	CONTRACEPTION	MEDICAL DEVICE COMPLICATION	19
PS	CONTRACEPTION	MENOMETRORRHAGIA	1
PS	CONTRACEPTION	MENORRHAGIA	2
PS	CONTRACEPTION	MENSTRUATION DELAYED	2
PS	CONTRACEPTION	MENSTRUATION IRREGULAR	2
PS	CONTRACEPTION	METRORRHAGIA	1
PS	CONTRACEPTION	MUSCLE SPASMS	3
PS	CONTRACEPTION	MUSCULOSKELETAL PAIN	1
PS	CONTRACEPTION	MYALGIA	1
PS	CONTRACEPTION	NAUSEA	2
PS	CONTRACEPTION	NIPPLE PAIN	1
PS	CONTRACEPTION	OLIGOMENORRHOEA	1
PS	CONTRACEPTION	OVARIAN CYST	3
PS	CONTRACEPTION	OVERDOSE	1
PS	CONTRACEPTION	PAIN	6
PS	CONTRACEPTION	PELVIC INFLAMMATORY DISEASE	4
PS	CONTRACEPTION	PELVIC PAIN	14
PS	CONTRACEPTION	PERITONEAL HAEMORRHAGE	1
PS	CONTRACEPTION	PREGNANCY AFTER POST COITAL CONTRACEPTION	1
PS	CONTRACEPTION	PREGNANCY TEST POSITIVE	1
PS	CONTRACEPTION	PREGNANCY WITH CONTRACEPTIVE DEVICE	16
PS	CONTRACEPTION	PRURITUS	1
PS	CONTRACEPTION	PYREXIA	4
PS	CONTRACEPTION	RASH	1
PS	CONTRACEPTION	RESPIRATORY ARREST	1
PS	CONTRACEPTION	RUPTURED ECTOPIC PREGNANCY	1
PS	CONTRACEPTION	SALPINGITIS	1
PS	CONTRACEPTION	SCAR	1
PS	CONTRACEPTION	SYNCOPE	1
PS	CONTRACEPTION	URINARY TRACT INFECTION	1
PS	CONTRACEPTION	URTICARIA	2
PS	CONTRACEPTION	UTERINE ABSCESS	1
PS	CONTRACEPTION	UTERINE DISORDER	1
PS	CONTRACEPTION	UTERINE ENLARGEMENT	1
PS	CONTRACEPTION	UTERINE HAEMATOMA	1
PS	CONTRACEPTION	UTERINE HAEMORRHAGE	6
PS	CONTRACEPTION	UTERINE LEIOMYOMA	2
PS	CONTRACEPTION	UTERINE PERFORATION	19
PS	CONTRACEPTION	UTERINE RUPTURE	1
PS	CONTRACEPTION	VAGINAL DISCHARGE	6
PS	CONTRACEPTION	VAGINAL HAEMORRHAGE	15
PS	CONTRACEPTION	VAGINAL INFECTION	2
PS	CONTRACEPTION	VISION BLURRED	1
PS	CONTRACEPTION	VOMITING	1
PS	CONTRACEPTION	VULVOVAGINAL PRURITUS	1
PS	CONTRACEPTION	WHITE BLOOD CELL COUNT INCREASED	1
PS	CONTRACEPTION	WOUND INFECTION	1
PS	DEVICE BREAKAGE	DEVICE BREAKAGE	1
PS	DEVICE BREAKAGE	EMOTIONAL DISTRESS	1
PS	DEVICE BREAKAGE	IMPAIRED WORK ABILITY	1
PS	DEVICE BREAKAGE	PAIN	1
PS	TOXICITY TO VARIOUS AGENTS	ARTHRALGIA	1
PS	TOXICITY TO VARIOUS AGENTS	CANDIDIASIS	1
PS	TOXICITY TO VARIOUS AGENTS	DEVICE TOXICITY	1
PS	TOXICITY TO VARIOUS AGENTS	DIZZINESS	1
PS	TOXICITY TO VARIOUS AGENTS	DYSPLASTIC NAEVUS	1
PS	TOXICITY TO VARIOUS AGENTS	FATIGUE	1
PS	TOXICITY TO VARIOUS AGENTS	MALAISE	1
PS	TOXICITY TO VARIOUS AGENTS	MIGRAINE	1
PS	TOXICITY TO VARIOUS AGENTS	NAUSEA	1
PS	TOXICITY TO VARIOUS AGENTS	NIGHT SWEATS	1
PS	TOXICITY TO VARIOUS AGENTS	PRURITUS	1
PS	TOXICITY TO VARIOUS AGENTS	PYREXIA	1
PS	TOXICITY TO VARIOUS AGENTS	SKIN DISORDER	1
PS	TOXICITY TO VARIOUS AGENTS	SKIN ULCER	1
PS	TOXICITY TO VARIOUS AGENTS	VISUAL ACUITY REDUCED	1
C	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	DEEP VEIN THROMBOSIS	1
C	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	INJURY	1
C	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	JOINT SWELLING	1
C	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	PAIN	1
C	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	PAIN IN EXTREMITY	1
C	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	PULMONARY EMBOLISM	1
C	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	THROMBOCYTOPENIA	1
C	ATTENTION DEFICIT/HYPERACTIVITY DISORDER	THROMBOPHLEBITIS SUPERFICIAL	1
C	CONTRACEPTION	DEEP VEIN THROMBOSIS	2
C	CONTRACEPTION	ERYTHEMA	1
C	CONTRACEPTION	INJURY	1
C	CONTRACEPTION	JOINT SWELLING	1
C	CONTRACEPTION	OEDEMA PERIPHERAL	1
C	CONTRACEPTION	PAIN	1
C	CONTRACEPTION	PAIN IN EXTREMITY	2
C	CONTRACEPTION	PULMONARY EMBOLISM	1
C	CONTRACEPTION	THROMBOCYTOPENIA	1
C	CONTRACEPTION	THROMBOPHLEBITIS SUPERFICIAL	1
C	CONTRACEPTION	THROMBOSIS	1
C	MENSTRUATION IRREGULAR	DEEP VEIN THROMBOSIS	1
C	MENSTRUATION IRREGULAR	INJURY	1
C	MENSTRUATION IRREGULAR	JOINT SWELLING	1
C	MENSTRUATION IRREGULAR	PAIN	1
C	MENSTRUATION IRREGULAR	PAIN IN EXTREMITY	1
C	MENSTRUATION IRREGULAR	PULMONARY EMBOLISM	1
C	MENSTRUATION IRREGULAR	THROMBOCYTOPENIA	1
C	MENSTRUATION IRREGULAR	THROMBOPHLEBITIS SUPERFICIAL	1

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