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Depression (39)
Agitation (23)
Acne (16)
I Feel Pregnant (15)
Anxiety (14)
Uterus Pain (10)
Agitation, Tremor, Acne, Muscle Spasms, Depression (9)
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Levonorgestrel Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 336 

Breast Tenderness, Breast Swelling (8273487-4)
on Apr 09, 2012 Female from UNITED STATES , weighting 126.0 lb, was diagnosed with
  • oral contraception
and was treated with Levonorgestrel And Ethinyl Estradiol. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: breast tenderness, breast swelling. Levonorgestrel And Ethinyl Estradiol dosage: N/A.

Papilloma Viral Infection, Menorrhagia (8270902-7)
Patient was taking Levonorgestrel And Ethinyl Estradiol. Patient felt the following Levonorgestrel side effects: papilloma viral infection, menorrhagia on Apr 04, 2012 from BRAZIL Additional patient health information: Female , 29 years of age, was diagnosed with
  • contraception
and. Levonorgestrel And Ethinyl Estradiol dosage: (levonorgestrel 0.05mg)/(ethinyl Estradiol 0.25mg) Per Day.

Pregnancy On Oral Contraceptive, Abortion Induced (8240639-9)
Adverse event was reported on Mar 22, 2012 by a Female taking Levonorgestrel And Ethinyl Estradiol (Dosage: 1 Df, 1x/day) was diagnosed with
  • contraception
and. Location: FRANCE , 43 years of age, After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: pregnancy on oral contraceptive, abortion induced.

Menstruation Irregular (8238852-X)
on Mar 23, 2012 Female from UNITED STATES , 27 years of age, was diagnosed with
  • post coital contraception
and was treated with Levonorgestrel. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: menstruation irregular. Levonorgestrel dosage: N/A.
Associated medications used:
  • Plan B One-step (1.5 Milligram;)



Pregnancy On Oral Contraceptive, Nausea, Headache, Endometriosis (8237098-9)
on Mar 15, 2012 Female from BRAZIL , 38 years of age, was diagnosed with
  • oral contraception
and was treated with Levonorgestrel + Ethinyl Estradiol. Patient felt the following Levonorgestrel side effects: pregnancy on oral contraceptive, nausea, headache, endometriosis. Levonorgestrel + Ethinyl Estradiol dosage: 1 Df, Qd. Patient was hospitalized.

Pregnancy After Post Coital Contraception, Vaginal Haemorrhage, Ectopic Pregnancy, Pain, Maternal Exposure During Pregnancy (8234071-1)
Patient was taking Levonorgestrel. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: pregnancy after post coital contraception, vaginal haemorrhage, ectopic pregnancy, pain, maternal exposure during pregnancy on Mar 26, 2012 from UNITED STATES Additional patient health information: Female , 26 years of age, weighting 115.0 lb, was diagnosed with
  • post coital contraception
and. Levonorgestrel dosage: One Pill.

Ocular Icterus, Pruritus (8231438-2)
Adverse event was reported on Mar 19, 2012 by a Female taking Levonorgestrel And Ethinyl Estradiol (Dosage: Unk) . Location: NORWAY , 20 years of age, Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: ocular icterus, pruritus.

Device Dislocation, Amenorrhoea (8203682-1)
on Mar 09, 2012 Female from CANADA , 27 years of age, weighting 99.98 lb, was treated with Levonorgestrel. Patient felt the following Levonorgestrel side effects: device dislocation, amenorrhoea. Levonorgestrel dosage: Unk.

Pulmonary Thrombosis (8202864-2)
on Mar 12, 2012 Female from UNITED STATES , 27 years of age, weighting 176.0 lb, was treated with Levonorgestrel. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: pulmonary thrombosis. Levonorgestrel dosage: N/A.

Abdominal Pain Upper, Abdominal Pain Lower (8198121-3)
Patient was taking Levonorgestrel. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: abdominal pain upper, abdominal pain lower on Feb 24, 2012 from UNITED STATES Additional patient health information: Female , weighting 136.0 lb, was diagnosed with
  • post coital contraception
and. Levonorgestrel dosage: First Dose Taken Within 24 Hours, Second Dose Taken 12 Hours Later.

Dysgeusia, Phaeochromocytoma, Tinnitus, Ear Discomfort, Chest Discomfort, Headache, Loss Of Consciousness, Nausea, Deafness (8187728-5)
Adverse event was reported on Mar 02, 2012 by a Female taking Levonorgestrel (Dosage: N/A) . Location: UNITED STATES , 19 years of age, Patient felt the following Levonorgestrel side effects: dysgeusia, phaeochromocytoma, tinnitus, ear discomfort, chest discomfort, headache, loss of consciousness, nausea, deafness.
Multiple prescriptions taken:
  • Mirena (20 Mcg/24hr, Cont)
Patient was hospitalized.

Device Dislocation, Amenorrhoea (8179879-6)
on Feb 29, 2012 Female from CANADA , 27 years of age, was treated with Levonorgestrel. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: device dislocation, amenorrhoea. Levonorgestrel dosage: Unk.

Hypertensive Crisis (8175372-5)
on Feb 28, 2012 Female from GERMANY , 44 years of age, weighting 147.9 lb, was treated with Levonorgestrel + Ethinyl Estradiol. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: hypertensive crisis. Levonorgestrel + Ethinyl Estradiol dosage: N/A.
Associated medications used:
  • Amitriptyline Hcl
  • Nitrolingual
  • Metoprolol Tartrate And Hydrochlorothiazide
  • Metoclopramide
  • Actemra (Date Of Last Dose Prior To Sae: 01/dec/2011)
  • Ramipril
Patient was hospitalized.

Foetal Exposure During Pregnancy, Congenital Naevus (8156519-3)
Patient was taking Levonorgestrel. Patient felt the following Levonorgestrel side effects: foetal exposure during pregnancy, congenital naevus on Feb 16, 2012 from IRELAND Additional patient health information: Male , weighting 7.01 lb, was diagnosed with
  • post coital contraception
and. Levonorgestrel dosage: N/A.
Multiple prescriptions taken:
  • Motilium
  • Herbal Preparation


Vomiting, Diarrhoea, Abdominal Distension, Ovarian Cyst Ruptured, Influenza Like Illness, Nausea, Abnormal Sleep-related Event, Dizziness, Abdominal Pain (8153275-X)
Adverse event was reported on Feb 01, 2012 by a Female taking Levonorgestrel (Dosage: N/A) . Location: UNITED STATES , 24 years of age, weighting 135.0 lb, After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: vomiting, diarrhoea, abdominal distension, ovarian cyst ruptured, influenza like illness, nausea, abnormal sleep-related event, dizziness, abdominal pain.
Multiple concurrent drugs taken:
  • Amphetamine And Dextroamphetamine Salts
  • Xyrem (Oral ; 7.5 Gm (3.75 Gm,2 In 1 D),oral)
  • Xyrem (Oral ; 7.5 Gm (3.75 Gm,2 In 1 D),oral)


Menorrhagia, Loss Of Consciousness, Vaginal Haemorrhage, Dizziness, Nausea (8142068-5)
on Feb 01, 2012 Female from UNITED STATES , 19 years of age, weighting 155.0 lb, was diagnosed with
  • post coital contraception
and was treated with Levonorgestrel. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: menorrhagia, loss of consciousness, vaginal haemorrhage, dizziness, nausea. Levonorgestrel dosage: 1st Tablet Within 1hour And 2nd Tablet 12 Hours Later.

Ocular Icterus, Pruritus (8139086-X)
on Feb 08, 2012 Female from NORWAY , 20 years of age, was treated with Levonorgestrel And Ethinyl Estradiol. Patient felt the following Levonorgestrel side effects: ocular icterus, pruritus. Levonorgestrel And Ethinyl Estradiol dosage: Unk.

Amenorrhoea, Device Dislocation (8137692-X)
Patient was taking Levonorgestrel. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: amenorrhoea, device dislocation on Feb 14, 2012 from CANADA Additional patient health information: Female , 27 years of age, . Levonorgestrel dosage: Unk.

Skin Necrosis, Thrombosis (8137443-9)
Adverse event was reported on Feb 02, 2012 by a Female taking Levonorgestrel (Dosage: N/A) . Location: FRANCE , 41 years of age, Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: skin necrosis, thrombosis.
Associated medications used:
  • Temodal (75 Mg/m2;qd, 220 Mg; 220 Mg; 220 Mg; 220; 220 Mg)
  • Temodal (75 Mg/m2;qd, 220 Mg; 220 Mg; 220 Mg; 220; 220 Mg)
  • Temodal (75 Mg/m2;qd, 220 Mg; 220 Mg; 220 Mg; 220; 220 Mg)
  • Temodal (75 Mg/m2;qd, 220 Mg; 220 Mg; 220 Mg; 220; 220 Mg)
  • Temodal (75 Mg/m2;qd, 220 Mg; 220 Mg; 220 Mg; 220; 220 Mg)
  • Keppra
  • Prednisolone


Caesarean Section, Dyspnoea, Maternal Exposure During Pregnancy (8131960-3)
on Feb 06, 2012 Female from BRAZIL , 15 years of age, was diagnosed with
  • menstrual cycle management
  • contraception
and was treated with Levonorgestrel + Ethinyl Estradiol. Patient felt the following Levonorgestrel side effects: caesarean section, dyspnoea, maternal exposure during pregnancy. Levonorgestrel + Ethinyl Estradiol dosage: N/A.

Maternal Exposure During Pregnancy, Pregnancy On Oral Contraceptive, Product Quality Issue (8129820-7)
on Feb 10, 2012 Female from UNITED STATES , 21 years of age, weighting 210.0 lb, was diagnosed with
  • contraception
and was treated with Levonorgestrel + Ethinyl Estradiol. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: maternal exposure during pregnancy, pregnancy on oral contraceptive, product quality issue. Levonorgestrel + Ethinyl Estradiol dosage: N/A.

Ectopic Pregnancy, Pregnancy After Post Coital Contraception, Abortion Spontaneous, Abdominal Pain Lower, Abdominal Pain Upper, Maternal Exposure During Pregnancy (8128762-0)
Patient was taking Levonorgestrel. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: ectopic pregnancy, pregnancy after post coital contraception, abortion spontaneous, abdominal pain lower, abdominal pain upper, maternal exposure during pregnancy on Jan 28, 2012 from UNITED STATES Additional patient health information: Female , weighting 136.0 lb, was diagnosed with
  • post coital contraception
and. Levonorgestrel dosage: First Dose Taken Within 24 Hours, Second Dose Taken 12 Hours Later.

Ectopic Pregnancy, Paraesthesia (8125450-1)
Adverse event was reported on Jan 25, 2012 by a Female taking Levonorgestrel (Dosage: 1st Tab Taken After 48h, 2nd Tab Taken Within 12h After 1st Tab) was diagnosed with
  • contraception
and. Location: UNITED STATES , weighting 154.0 lb, Patient felt the following Levonorgestrel side effects: ectopic pregnancy, paraesthesia. Patient was hospitalized.

Bronchitis (8124297-X)
on Feb 06, 2012 Female from GERMANY , 24 years of age, was treated with Levonorgestrel. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: bronchitis. Levonorgestrel dosage: Unk.

Intracranial Venous Sinus Thrombosis (8108133-3)
on Jan 25, 2012 Female from FRANCE , 53 years of age, was treated with Levonorgestrel And Ethinyl Estradiol. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: intracranial venous sinus thrombosis. Levonorgestrel And Ethinyl Estradiol dosage: N/A.
Associated medications used:
  • Nozinan (Unk)
  • Diltiazem Hcl (Unk)
  • Artane (Unk)
Patient was hospitalized.

Showing 1-25 of 336 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Levonorgestrel Information

Alternative LEVONORGESTREL Names:ETHINYL E LEVONORGE NEXT CHOI

Active Ingredient: LEVONORGE

More About Levonorgestrel

Side Effects reported to FDA: 336. View Levonorgestrel Adverse Reports

Levonorgestrel safety alerts: 2012 2002 2000

Reported deaths: 8

Reported hospitalizations: 42

Introvale (levonorgestrel and ethinyl estradiol) Tablets: Recall - Packaging Flaw

 

[Posted 06/06/2012]

AUDIENCE: Consumer, Pharmacy

ISSUE: Sandoz notified the public that it issued a voluntary recall of 10 lots of its generic oral contraceptive Introvale in the US, following a recent report of a packaging flaw. A consumer reported that the white placebo tablets were mistakenly in the ninth row (labeled “Week 9”) of the 13-row blister card, rather than in the correct position in the 13th and final row (labeled “Week 13”). Each three-month blister card contains 84 peach-colored active tablets and seven white placebo tablets in 13 rows, each representing one week. While the white placebo tablets can be clearly distinguished from the peach-colored active tablets, the risk of an unintended pregnancy for a patient taking the wrong tablet over several days cannot be excluded.

The lot numbers involved in the recall are as follows: LF00478C, LF00479C, LF00551C, LF00552C, LF00687C, LF00688C, LF00763C, LF00764C, LF00765C and LF01261C. These lots were distributed only in the US between January 2011 and May 2012. 

BACKGROUND: Introvale is an extended-cycle oral contraceptive. Sandoz is not aware of any reports of related adverse events.

RECOMMENDATION: If a patient finds a white placebo tablet in any position other than the 13th and final row (Week 13), they should immediately begin using a non-hormonal form of contraception and contact their healthcare professional.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[06/05/2012 - Press Release - Sandoz]

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