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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