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Levonorgestrel Side Effects

Report Levonorgestrel Side Effects

If you experienced any harmful or unwanted effects of Levonorgestrel, please share your experience. This could help to raise awareness about Levonorgestrel side effects, identify uknown risks and inform health professionals and patients taking Levonorgestrel.

Examples: headache, dizziness


The most commonly reported Levonorgestrel side effects are:
Depression (40 reports)
Agitation (24 reports)
Acne (16 reports)
I Feel Pregnant (15 reports)
Anxiety (14 reports)
Uterus Pain (10 reports)
Agitation, Tremor, Acne, Muscle Spasms, Depression (9 reports)
Gain (7 reports)
Muscle Spasms (7 reports)

If you have experienced a side effect listed above, you can check a box to report it.


To view a complete list of submitted side effects, please follow the link Levonorgestrel side effects . You can also compare Levonorgestrel side effects or view FDA reports.

Levonorgestrel Side Effects reported to FDA

The following Levonorgestrel reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
The FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Levonorgestrel on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has identified a causal relationship between the drug and the listed risk.

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Porphyria, Inappropriate Antidiuretic Hormone Secretion, Neuropathy Peripheral
on Jan 14, 2013 Female from COUNTRY NOT SPECIFIED , 28 years of age, was treated with Levonorgestrel. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: porphyria, inappropriate antidiuretic hormone secretion, neuropathy peripheral. Levonorgestrel dosage: N/A.

Arterial Haemorrhage, Device Difficult To Use
Patient was taking Levonorgestrel. Patient felt the following Levonorgestrel side effects: arterial haemorrhage, device difficult to use on Jan 02, 2013 from IL Additional patient health information: Female , 51 years of age, . Levonorgestrel dosage: 20 Mcg/24hr, Cont.

Diarrhoea Haemorrhagic, Nausea, Vomiting
Adverse event was reported on Dec 28, 2012 by a Female taking Levonorgestrel 1.5 Mg Tablet (Dosage: N/A) was diagnosed with and. Location: BE , 45 years of age, After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: diarrhoea haemorrhagic, nausea, vomiting.

Syncope, Cardio-respiratory Arrest, Device Difficult To Use
on Dec 12, 2012 Female from NL , 35 years of age, was diagnosed with and was treated with Levonorgestrel. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: syncope, cardio-respiratory arrest, device difficult to use. Levonorgestrel dosage: 20 Mcg/24hr, Cont.


Menorrhagia
on Nov 02, 2012 Female from US , 29 years of age, weighting 172.0 lb, was treated with Levonorgestrel. Patient felt the following Levonorgestrel side effects: menorrhagia. Levonorgestrel dosage: N/A.

Ovarian Cyst, Amenorrhoea, Vaginal Haemorrhage, Abdominal Pain
Patient was taking Levonorgestrel. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: ovarian cyst, amenorrhoea, vaginal haemorrhage, abdominal pain on Oct 26, 2012 from US Additional patient health information: Female , 31 years of age, weighting 185.0 lb, was diagnosed with and. Levonorgestrel dosage: 0.75 Mg, Single At 1200.

Metrorrhagia
Adverse event was reported on Oct 11, 2012 by a Female taking Levonorgestrel, Ethinyl Estradiol (Dosage: 90/20 Mcg, Daily) was diagnosed with
  • menorrhagia
  • mood swings
  • loss of consciousness
  • malaise
  • rheumatoid arthritis
and. Location: US , 44 years of age, weighting 145.1 lb, Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: metrorrhagia.

Pregnancy After Post Coital Contraception, Exposure During Pregnancy, Abortion Spontaneous
on Oct 02, 2012 Female from GB , 33 years of age, was diagnosed with and was treated with Levonorgestrel 1.5 Mg Tablet. Patient felt the following Levonorgestrel side effects: pregnancy after post coital contraception, exposure during pregnancy, abortion spontaneous. Levonorgestrel 1.5 Mg Tablet dosage: N/A.

Intracranial Venous Sinus Thrombosis
on Oct 03, 2012 Female from US , 40 years of age, weighting 241.0 lb, was diagnosed with and was treated with Levonorgestrel/ethinyl Estradiol. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: intracranial venous sinus thrombosis. Levonorgestrel/ethinyl Estradiol dosage: 1pill Once A Day Po . Patient was hospitalized.

Ovarian Cyst Ruptured, Fungal Infection, Convulsion, Pelvic Pain
Patient was taking Levonorgestrel. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: ovarian cyst ruptured, fungal infection, convulsion, pelvic pain on Sep 27, 2012 from US Additional patient health information: Female , 26 years of age, . Levonorgestrel dosage: 20 ?g/d, Cont.
Associated medications used:
  • Motrin (800 Mg, Unk)
  • Lamictal (250 Mg, Qd)
Patient was hospitalized.

Pelvic Inflammatory Disease, Vaginitis Bacterial
Adverse event was reported on Sep 27, 2012 by a Female taking Levonorgestrel (Dosage: N/A) . Location: US , 19 years of age, Patient felt the following Levonorgestrel side effects: pelvic inflammatory disease, vaginitis bacterial. Patient was hospitalized.

Pelvic Inflammatory Disease
on Sep 27, 2012 Female from US , 17 years of age, was treated with Levonorgestrel. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: pelvic inflammatory disease. Levonorgestrel dosage: N/A.

Uterine Leiomyoma
on Sep 06, 2012 Female from MT , 45 years of age, was diagnosed with and was treated with Levonorgestrel. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: uterine leiomyoma. Levonorgestrel dosage: 20 Mcg/24hr, Cont.

Candidiasis, Metrorrhagia, Nausea, Vomiting, Headache
Patient was taking Levonorgestrel + Ethinyl Estradiol. Patient felt the following Levonorgestrel side effects: candidiasis, metrorrhagia, nausea, vomiting, headache on Sep 10, 2012 from ES Additional patient health information: Female , 21 years of age, weighting 132.3 lb, was diagnosed with and. Levonorgestrel + Ethinyl Estradiol dosage: Unk.

Breast Cancer Female, Metrorrhagia
Adverse event was reported on Sep 26, 2012 by a Female taking Levonorgestrel (Dosage: Daily Dose 20 ?g) was diagnosed with and. Location: JP , 41 years of age, weighting 211.6 lb, After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: breast cancer female, metrorrhagia.
Multiple concurrent drugs taken:

Abnormal Withdrawal Bleeding
on Jun 19, 2012 Female from FRANCE , 24 years of age, was diagnosed with and was treated with Levonorgestrel. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: abnormal withdrawal bleeding. Levonorgestrel dosage: 1 Df, Qd.
Associated medications used:

Menstruation Irregular, Abortion Spontaneous
on Jun 02, 2012 Female from UNITED STATES , 25 years of age, was treated with Levonorgestrel. Patient felt the following Levonorgestrel side effects: menstruation irregular, abortion spontaneous. Levonorgestrel dosage: Unk.

Multi-organ Failure, Parotid Gland Enlargement, Lymphadenopathy, Influenza Like Illness, Tonsillar Hypertrophy, Dizziness, Fatigue, Eye Swelling, Sepsis
Patient was taking Levonorgestrel. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: multi-organ failure, parotid gland enlargement, lymphadenopathy, influenza like illness, tonsillar hypertrophy, dizziness, fatigue, eye swelling, sepsis on Jun 01, 2012 from UNITED KINGDOM Additional patient health information: Female , 22 years of age, . Levonorgestrel dosage: N/A. Patient was hospitalized.

Multi-organ Failure, Peritonsillar Abscess, Eye Swelling, Lemierre Syndrome, Eye Discharge
Adverse event was reported on May 23, 2012 by a Female taking Levonorgestrel (Dosage: N/A) . Location: UNITED KINGDOM , 22 years of age, Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: multi-organ failure, peritonsillar abscess, eye swelling, lemierre syndrome, eye discharge. Patient was hospitalized.

Vision Blurred, Eye Pain, Vulvovaginal Dryness, Product Label Issue, Oedema Peripheral, Hyperhidrosis, Flatulence, Diplopia, Dry Eye
on Jun 04, 2012 Female from UNITED STATES , 32 years of age, weighting 245.0 lb, was treated with Levonorgestrel And Ethinyl Estradiol. Patient felt the following Levonorgestrel side effects: vision blurred, eye pain, vulvovaginal dryness, product label issue, oedema peripheral, hyperhidrosis, flatulence, diplopia, dry eye. Levonorgestrel And Ethinyl Estradiol dosage: N/A.

Breast Cancer Female, Metrorrhagia
on May 29, 2012 Female from JAPAN , 41 years of age, weighting 211.6 lb, was diagnosed with and was treated with Levonorgestrel. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: breast cancer female, metrorrhagia. Levonorgestrel dosage: Daily Dose 20 ?g.
Multiple concurrent drugs taken:

Galactorrhoea, Metrorrhagia, Vaginal Haemorrhage
Patient was taking Levonorgestrel. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: galactorrhoea, metrorrhagia, vaginal haemorrhage on May 23, 2012 from DENMARK Additional patient health information: Female , 30 years of age, was diagnosed with and. Levonorgestrel dosage: 20 ?g/day, Cont.

Thyroid Neoplasm
Adverse event was reported on May 25, 2012 by a Female taking Levonorgestrel (Dosage: 50 Ug, Unk) . Location: AUSTRALIA , weighting 175.3 lb, Patient felt the following Levonorgestrel side effects: thyroid neoplasm.
Multiple prescriptions taken:
  • Triphasil-21 (1 Df, Qd)
  • Ethinyl Estradiol (30 Ug, Unk)
  • Norvasc (10 Mg, Qd)
  • Ethinyl Estradiol (40 Ug, Unk)


Pulmonary Embolism, Psoriasis, Pneumonia
on May 23, 2012 Female from FRANCE , weighting 136.7 lb, was diagnosed with and was treated with Levonorgestrel And Ethinyl Estradiol. After Levonorgestrel was administered, patient encountered several Levonorgestrel side effects: pulmonary embolism, psoriasis, pneumonia. Levonorgestrel And Ethinyl Estradiol dosage: N/A.
Multiple concurrent drugs taken: Patient was hospitalized.

Peritonsillar Abscess, Multi-organ Failure, Jugular Vein Thrombosis, Fatigue, Sepsis, Body Temperature Increased, Nausea, Tonsillar Hypertrophy, Influenza Like Illness
on May 18, 2012 Female from UNITED KINGDOM , 22 years of age, was treated with Levonorgestrel. Directly after, patient experienced the unwanted or unexpected Levonorgestrel side effects: peritonsillar abscess, multi-organ failure, jugular vein thrombosis, fatigue, sepsis, body temperature increased, nausea, tonsillar hypertrophy, influenza like illness. Levonorgestrel dosage: N/A. Patient was hospitalized.

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Record and Track Your Side Effects

It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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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.

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JustAnswer.com

Safety Alerts, Active Ingredients, Usage Information

Alternative LEVONORGESTREL Names:ETHINYL E LEVONORGE NEXT CHOI

Active Ingredient: LEVONORGE

More About Levonorgestrel

Side Effects reported to FDA: 377

Levonorgestrel safety alerts: 2012 2002 2000

Reported deaths: 10

Reported hospitalizations: 50

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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